AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is publishing an annual comprehensive list of all guidance documents currently in use at the agency. We committed to publishing this list in our February 1997 “Good Guidance Practices” (GGP's), which set forth our policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of all our current guidance documents.
DATES:
We welcome general comments on this list and on agency guidance documents at any time.
ADDRESSES:
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. We have provided information on where to obtain a single copy of any of the guidance documents listed in the specific Center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT:
LaJuana D. Caldwell, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), we announced our GGP's—our policies and procedures for developing, issuing, and using guidance documents. We adopted the GGP's to ensure your involvement in the development of guidance documents and to enhance your understanding of the availability, nature, and legal effect of such guidance.
As part of our effort to ensure meaningful interaction with the public regarding guidance documents, we committed to publish an annual comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including “Level 2” guidance documents.
A. Plain Language in Guidance Documents
On June 1, 1998, the President instructed all Federal agencies to ensure the use of “plain language” in all new documents. As part of this initiative, We use the principles of “plain language” set forth by the President when writing our guidance documents. We seek your comments on the clarity of our guidances.
B. How the List is Organized
The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA Internet home page. We will update and publish this list in the Federal Register every year. We organized the guidance documents in this comprehensive list by the issuing Center or Office within FDA, and we further grouped them by the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. We also provide document numbers when they are available.
II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How to Obtain a Hard Copy of the Document |
|---|---|---|---|
| Interpretative Guidelines of the Source Plasma (Human) Standards | October 2, 1973 | FDA Regulated Industry | Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber |
| Guidelines for Reviewing Amendments to Include Plasmapheresis of Hemophiliacs | July 20, 1976 | Do | Do |
| Package Insert: Immune Serum Globulin (Human) | March 30, 1978 | Do | Do |
| Guidelines for Interpretation of Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids | April 12, 1979 | Do | Do |
| Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances | June 1, 1980 | Do | Do |
| Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes) | January 28, 1981 | Do | Do |
| Platelet Testing Guidelines—Approval of New Procedures and Equipment | July 1, 1981 | Do | Do |
| Revised Guideline for Adding Heparin to Empty Containers for Collection of Heparinized Source Plasma (Human) | August 1, 1981 | Do | Do |
| Requirements for Infrequent Plasmapheresis Donors | August 27, 1982 | Do | Do |
| Recommendations to Decrease the Risk of Transmitting AIDS from Plasma Donors | March 24, 1983 | Do | Do |
| PTC in the Manufacture of In Vitro Monoclonal Antibody Products Subject to Licensure | June 20, 1983 | Do | Do |
| Draft PTC in the Production and Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures) | July 28, 1983 | Do | Do |
| Interstate Shipment of Interferon for Investigational Use in Laboratory Research Animals or Tests in Vitro | November 21, 1983 | Do | Do |
| Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin/Roche); 13-cis-retinoic acid) | February 28, 1984 | Do | Do |
| Equivalent Methods for Compatibility Testing | December 14, 1984 | Do | Do |
| Plasma Derived from Therapeutic Plasma Exchange | December 14, 1984 | Do | Do |
| Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology | April 10, 1985 | Do | Do |
| Guidelines for Meningococcal Polysaccharide Vaccines | July 17, 1985 | Do | Do |
| Guideline for the Uniform Labeling of Blood and Blood Components | August 1, 1985 | Do | Do |
| Recommended Methods for Short Ragweed Pollen Extracts | November 1, 1985 | Do | Do |
| Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved Container | June 2, 1986 | Do | Do |
| To In Vitro Diagnostic Reagent Manufacturers: Guidance On the Labeling of Human Blood Derived In Vitro Diagnostic Devices In Regard to Labeling for HTLV-III/LAV Antibody Testing | December 6, 1986 | Do | Do |
| Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Guideline On General Principles of Process Validation | May 1, 1987 | Do | Do |
| Guideline On Sterile Drug Products Produced by Aseptic Processing | June 1, 1987 | Do | Do |
| Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone | November 25, 1987 | Do | Do |
| Guideline On Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices | December 1, 1987 | Do | Do |
| Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) | December 2, 1987 | Do | Do |
| Extension of Dating Period for Storage of Red Blood Cells, Frozen | December 4, 1987 | Do | Do |
| To Licensed In-Vitro Diagnostic Manufacturers: Handling of Human Blood Source Materials | December 23, 1987 | Do | Do |
| Recommendations for Implementation of Computerization in Blood Establishments | April 6, 1988 | Do | Do |
| Control of Unsuitable Blood and Blood Components | April 6, 1988 | Do | Do |
| Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines | July 7, 1988 | Do | Do |
| Physician Substitutes | August 15, 1988 | Do | Do |
| To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot Release | August 26, 1988 | Do | Do |
| Revised Guideline for the Collection of Platelets, Pheresis | October 7, 1988 | Do | Do |
| To Manufacturers of HTLV-I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I | October 18, 1988 | Do | Do |
| Draft Guideline for the Design of Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses | November 1, 1988 | Do | Do |
| HTLV-1 Antibody Testing | November 29, 1988 | Do | Do |
| Use of Recombigen HIV-1 LA Test | February 1, 1989 | Do | Do |
| Guidelines for Release of Pneumococcal Vaccine, Polyvalent | February 1, 1989 | Do | Do |
| Guidance for Autologous Blood and Blood Components | March 15, 1989 | Do | Do |
| HTLV-I Antibody Testing | July 6, 1989 | Do | Do |
| Use of Recombigen HIV-1 Latex Agglutination (LA) Test | August 1, 1989 | Do | Do |
| Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989) | August 8, 1989 | Do | Do |
| PTC in the Collection, Processing and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans | August 22, 1989 | Do | Do |
| Information Relevant to the Manufacture of Acellular Pertussis Vaccine | August 23, 1989 | Do | Do |
| FDA Regulated Industries for Drug Master Files | September 1, 1989 | Do | Do |
| Requirements for Computerization of Blood Establishments | September 8, 1989 | Do | Do |
| Abbott Laboratories' HIVAG-1 Test for HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments | October 4, 1989 | Do | Do |
| Guideline for Collection of Blood or Blood Products from Donors With Positive Tests for Infectious Disease Markers (“High Risk” Donors) | October 26, 1989 | Do | Do |
| Guideline for Determination of Residual Moisture in Dried Biological Products | January 1, 1990 | Do | Do |
| Autologous Blood Collection and Processing Procedures | February 12, 1990 | Do | Do |
| Cytokine and Growth Factor Pre-Pivotal Trial Information Package | April 2, 1990 | Do | Do |
| Use of Genetic Systems HIV-2 EIA | June 21, 1990 | Do | Do |
| PTC in the Safety Evaluation of Hemoglobin-Based Oxygen Carriers | August 21, 1990 | Do | Do |
| Guideline on the Preparation of Investigational New Drug Products (Human & Animal) | March 1, 1991 | Do | Do |
| FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica | March 15, 1991 | Do | Do |
| Revision to October 26, 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (High Risk Donors) | March 17, 1991 | Do | Do |
| Deficiencies Relating to the Manufacture of Blood and Blood Components | March 20, 1991 | Do | Do |
| Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components | March 20, 1991 | Do | Do |
| To Biologic Product Manufacturers—Controlling Materials of Bovine or Ovine Origin | May 3, 1991 | Do | Do |
| FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) | September 10, 1991 | Do | Do |
| Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCV | September 11, 1991 | Do | Do |
| Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing | December 12, 1991 | Do | Do |
| Recommended Methods for Blood Grouping Reagents Evaluation | March 1, 1992 | Do | Do |
| Recommended Methods for Evaluating Potency, Specificity and Reactivity of Anti-Human Globulin | March 1, 1992 | Do | Do |
| PTC in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin | March 1, 1992 | Do | Do |
| PTC in the Manufacture of In Vitro Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagents and Anti-Human Globulin | March 1, 1992 | Do | Do |
| Supplement to the PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability | April 6, 1992 | Do | Do |
| Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products | April 23, 1992 | Do | Do |
| Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA) | April 23, 1992 | Do | Do |
| Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | April 23, 1992 | Do | Do |
| Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120 | April 23, 1992 | Do | Do |
| Changes in Equipment for Processing Blood Donor Samples | July 21, 1992 | Do | Do |
| Nomenclature for Monoclonal Blood Grouping Reagents | September 28, 1992 | Do | Do |
| Volume Limits for Automated Collection of Source Plasma | November 4, 1992 | Do | Do |
| FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics | November 25, 1992 | Do | Do |
| Revision of October 7, 1988 Memo Concerning Red Blood Cell Immunization Programs | December 16, 1992 | Do | Do |
| Draft PTC in the Characterization of Cell Lines Used to Produce Biologicals | July 12, 1993 | Do | Do |
| CBER Refusal to File (RTF) Guidance for Product and Establishment License Applications | July 12, 1993 | Do | Do |
| Alternatives to Lot Release | July 20, 1993 | Do | Do |
| Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products | July 22, 1993 | Do | Do |
| Deferral of Blood and Plasma Donors based on Medications | July 28, 1993 | Do | Do |
| Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | August 19, 1993 | Do | Do |
| Changes in administrative procedures | September 9, 1993 | Do | Do |
| To Sponsors of IND's using Retroviral Vectors | September 20, 1993 | Do | Do |
| Draft Guideline for the Validation of Blood Establishment Computer Systems | September 28, 1993 | Do | Do |
| Methods of the Allergenic Products Testing Laboratory | October 1, 1993 | Do | Do |
| Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice | October 14, 1993 | Do | Do |
| Guideline for Adverse Experience Reporting for Licensed Biological Products | October 15, 1993 | Do | Do |
| Guidance Regarding Post Donation Information Reports | December 10, 1993 | Do | Do |
| To Manufacturers: Bovine Derived Materials (BSE) | December 17, 1993 | Do | Do |
| Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a history of Viral Hepatitis | December 22, 1993 | Do | Do |
| Compliance Program Guidance Manual (Drugs and Biologics) | 1994 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050, (Publication No. 94-920699) |
| Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen Donors | January 3, 1994 | Do | Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber |
| To Blood Establishment Computer Software Manufacturers | March 31, 1994 | Do | Do |
| To Sponsors of IND's for Human Immunoglobulin Products | May 23, 1994 | Do | Do |
| To Manufacturers of Licensed Anti-HIV Test Kits | May 26, 1994 | Do | Do |
| Recommendations for Deferral of Donors for Malaria Risk | July 26, 1994 | Do | Do |
| ICH Guideline for Industry: Studies in Support of Special Populations | August 1, 1994 | Do | Do |
| OELPS, Advertising and Promotional Labeling Staff Procedural Guidance Document (Draft) | August 1, 1994 | Do | Do |
| Use of and FDA Cleared or Approved Sterile Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo) | August 5, 1994 | Do | Do |
| ICH Guideline for Industry: Stability Testing of New Drug Substances and Products | September 1, 1994 | Do | Do |
| Guide to Inspections of Blood Banks, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs | September 1, 1994 | FDA Personnel | Do |
| Letter to Manufacturers of Immune Globulin Intravenous (Human)(IGIV), Aseptic Meningitis Syndrome | October 3, 1994 | FDA Regulated Industry | Do |
| Guidance on Alternatives to Lot Release for Licensed Biological Products | October 27, 1994 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances | November 1994 | Do | Do |
| Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems | December 20, 1994 | Do | Do |
| To Manufacturers of Immune Globulin Products: Testing for Hepatitis C Virus RNA Immunoglobulin | December 27, 1994 | Do | Do |
| Timeframe for Licensing Irradiated Blood Products | February 3, 1995 | Do | Do |
| To Blood Establishment Computer Software Manufacturers | February 10, 1995 | Do | Do |
| Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance | February 23, 1995 | Do | Do |
| ICH Guideline for Industry: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | March 1, 1995 | Do | Do |
| To Manufacturers of Intramuscular Immune Globulin Products: HCV RNA Testing by PCR | March 3, 1995 | Do | Do |
| Revision of August 27, 1982 FDA Memo: Requirements for Infrequent Plasmapheresis Donors | March 10, 1995 | Do | Do |
| To Manufacturers of Intramuscular Immune Globulin Products: additional information regarding HCV RNA testing by PCR | March 13, 1995 | Do | Do |
| To Health Professionals: Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration | March 14, 1995 | Do | Do |
| To All Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma | March 14, 1995 | Do | Do |
| Reviewer Guidance, Computer Software | March 26, 1995 | FDA Personnel | Do |
| Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma | June 8, 1995 | FDA Regulated Industry | Do |
| Guideline for Quality Assurance in Blood Establishments | July 11, 1995 | Do | Do |
| FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products | July 11, 1995 | Do | Do |
| Disposition of Products Derived from Donors Diagnosed with, or at Known HighRisk for, Creutzfeldt-Jakob Disease | August 8, 1995 | Do | Do |
| Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT) | August 8, 1995 | Do | Do |
| Precautionary Measures to Further Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products | August 8, 1995 | Do | Do |
| Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen | August 8, 1995 | Do | Do |
| PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals | August 22, 1995 | Do | Do |
| Informed Consent for Plasmapheresis/Immunization | October 1, 1995 | FDA Personnel | Do |
| Draft Reviewers' Guide: Changes in Personnel | October 1, 1995 | FDA Personnel | Do |
| Disease Associated Antibody Collection Program | October 1, 1995 | FDA Personnel | Do |
| Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products | November 1, 1995 | FDA Regulated Industry | Do |
| Guidance Concerning Conversion to FDA-Reviewed Software Products | November 13, 1995 | Do | Do |
| Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis | December 4, 1995 | Do | Do |
| Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products | December 8, 1995 | Do | Do |
| Dear Colleague: Regarding Reverse Transcriptase Activity in Viral Vaccines Produced in Chicken Cells | January 4, 1996 | Do | Do |
| Requesting All Manufacturers Immediately to Revise Warning Section for Package Insert on Thrombin | January 4, 1996 | Do | Do |
| ICH Final Guideline: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein Products | February 23, 1996 | Do | Do |
| ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Study of Pharmaceuticals | March 1, 1996 | Do | Do |
| Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen | March 14, 1996 | Do | Do |
| FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products | March 26, 1996 | Do | Do |
| ICH Guideline on the Detection of Toxicity to Reproduction for Medicinal Products; Addendum on Toxicity to Male Fertility | April 5, 1996 | Do | Do |
| ICH Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals | April 24, 1996 | Do | Do |
| To Manufacturers of FDA-Regulated Drug/Biological/Device Products, Bovine Spongiform Encephalopathy (BSE) | May 9, 1996 | Do | Do |
| Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) | May 16, 1996 | Do | Do |
| Guidance for Industry—The Content and Format for Pediatric Use Supplements | May 23, 1996 | Do | Do |
| Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction | May 24, 1996 | Do | Do |
| Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products | May 29, 1996 | Do | Do |
| Guide to Inspections of Infectious Disease Marker Testing Facilities | June 1, 1996 | FDA Personnel | Do |
| To Manufacturers: Implementation of testing for Hepatitis C virus RNA by Manufacturers: Implementation of testing for Hepatitis C virus RNA by polymerase chain reaction (PCR) of intramuscular immune globulin preparations | June 13, 1996 | FDA Regulated Industry | Do |
| ICH Final Guidelines on Stablity Testing of Biotechnological/Biological Products | July 10, 1996 | ||
| ICH Guideline on Structure and Content of Clinical Study Reports | July 17, 1996 | Do | Do |
| Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I) | July 19, 1996 | Do | Do |
| To Manufacturers: HIV-1 Group O | July 31, 1996 | Do | Do |
| Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use | August 15, 1996 | Do | Do |
| ICH Revised Guidance: Single Dose Acute Toxicity Testing for Pharmaceuticals | August 26, 1996 | Do | Do |
| Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation; Notice | September 23, 1996 | Do | Do |
| ICH Draft Guideline on Data Elements for Transmission of Individual Case Reports | October 1, 1996 | Do | Do |
| To All Plasma Derivative Manufacturers and to ABRA: Warning Statement for Plasma Derivative Product Labeling | October 7, 1996 | Do | Do |
| Advertising and Promotion; Guidance; Notice | October 8, 1996 | Do | Do |
| To Biologic Product Manufacturers: Revised Procedures for Internal Labeling Review Number Assignment | December 3, 1996 | Do | Do |
| Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection | December 11, 1996 | Do | Do |
| PTC on Plasmid DNA Vaccines for Preventive Infectious Disease Indications | December 22, 1996 | Do | Do |
| Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products | January 1997 | Do | Do |
| Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software | January 13, 1997 | FDA Personnel | Do |
| The Food and Drug Administration's Development, Issuance, and Use of Guidance Documents | February 27, 1997 | FDA Regulated Industry | Do |
| Proposed Approach to Regulation of Cellular and Tissue-Based Products | February 27, 1997 | Do | Do |
| PTC in the Manufacture and Testing of Monoclonal Antibody Products for Human Use | February 28, 1997 | Do | Do |
| Tables 1 and 2 from Proposed Approach to Regulation of Cellular and Tissue-Based Products | March 4, 1997 | Do | Do |
| Preclearance of Promotional Labeling; Clarification | March 5, 1997 | Do | Do |
| Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies | April 1997 | Do | Do |
| ICH Draft Guideline on Dose Selection for Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit Dose | April 2, 1997 | Do | Do |
| ICH Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | May 2, 1997 | Do | Do |
| ICH Draft Guideline on Impurities: Residual Solvents | May 2, 1997 (Correction May 19, 1997) | Do | Do |
| ICH Guideline on Stability Testing for New Dosage Forms | May 9, 1997 | Do | Do |
| ICH Draft Guideline on Statistical Principles for Clinical Trials, Part III | May 9, 1997 | Do | Do |
| ICH Good Clinical Practice: Consolidated Guideline, Part II | May 9, 1997 | Do | Do |
| ICH Guideline for the Photostability Testing of New Drug Substances and Products, Part II | May 16, 1997 | Do | Do |
| ICH Guideline on Impurities in New Drug Products, Part IV | May 19, 1997 | Do | Do |
| ICH Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for marketed Drugs, Part VI | May 19, 1997 | Do | Do |
| ICH Guideline on the Validatioin of Analytical Procedures: Methodology, Part V | May 19, 1997 | Do | Do |
| To Plasma Fractionators—CBER's View on Product Recalls Conducted by the Plasma Fractionation Industry | May 29, 1997 | Do | Do |
| ICH Draft Guideline on General Considerations for Clinical Trials | May 30, 1997 | Do | Do |
| Guide to Inspections of Source Plasma Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs) | June 1, 1997 | FDA Personnel | Do |
| Draft Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability | June 18, 1997 | FDA Regulated Industry | Do |
| Guidance for Industry—Changes to an Approved Application: Biological Products | July 1997 | Do | Do |
| Guidance for Industry—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products | July 1997 | Do | Do |
| Guidance for Industry—Screening and Testing of Donors of Human Tissue Intended for Transplantation | July 1997 | Do | Do |
| Guidance for Industry—Donor Screening for Antibodies to HTLV-II | August 1997 | Do | Do |
| Draft Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts | August 1997 | Do | Do |
| Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report | August 1997 | Do | Do |
| Draft Guidance for Industry Efficacy Evaluation of Hemoglobin-and Perfluorocarbon-Based Oxygen Carriers | September 1997 | Do | Do |
| Guidance for Industry -The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use | September 1997 | Do | Do |
| Notification Process for Transfusion Related Fatalities and Donation Related Deaths (revised telephone number) | October 7, 1997 | Do | Do |
| Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries | October 15, 1997 | Do | Do |
| ICH Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | November 18, 1997 | Do | Do |
| ICH Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals | November 21, 1997 | Do | Do |
| ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | November 25 1997 | Do | Do |
| ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | November 25, 1997 | Do | Do |
| Guidance for FDA and Industry: Direct Final Rule Procedures | November 21, 1997 | FDA Personnel and Regulated Industry | Do |
| Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) | December 1997 | FDA Regulated Industry | Do |
| Guidance for Industry: Industry-Supported Scientific and Educational Activities | December 3, 1997 | Do | Do |
| ICH Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes | December 4, 1997 | Do | Do |
| To Biologic Product Manufacturers—Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or At Increased Risk For, CJD | December 11, 1997 | Do | Do |
| To Allergenic Extract Manufacturers—Standardized Grass Pollen Extracts | December 23, 1997 | Do | Do |
| ICH Guidance on Data Elements for Transmission of Individual Case Safety Reports | January 15, 1998 | ||
| Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products | January 1998 | Do | Do |
| Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products | January 1998 | Do | Do |
| ICH Guidance on Testing for Carncinogenicity of Pharmaceuticals | February 28, 1998 | ||
| Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients | March 1998 | Do | Do |
| Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy | March 1998 | Do | Do |
| Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research | May 1998 | Do | Do |
| Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological Products | May 1998 | Do | Do |
| Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds | May 1998 | Do | Do |
| Guidance for Industry: Classifying Resubmissions in Response to Action Letters | May 1998 | Do | Do |
| Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling | May 1998 | Do | Do |
| Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements | May 1998 | Do | Do |
| Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products | May 1998 | Do | Do |
| Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products | June 1998 | Do | Do |
| Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act | June 1998 | Do | Do |
| Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing | June 1998 | Do | Do |
| ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | June 9, 1998 | Do | Do |
| ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data | June 10, 1998 | Do | Do |
| Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 | June 12, 1998 | Do | Do |
| Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements | July 1998 | Do | Do |
| Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications | July 1998 | Do | Do |
| Draft Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods | July 1998 | Do | Do |
| Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV | September 1998 | Do | Do |
| Draft Guidance for Industry: Submitting Debarment Certification Statements | September 1998 | Do | Do |
| Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) | September 1998 | Do | Do |
| Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application Review | September 1998 | Do | Do |
| ICH Guidance on Statistical Principles for Clinical Trials | September 16, 1998 | Do | Do |
| ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products | September 21, 1998 | Do | Do |
| ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin | September 24, 1998 | Do | Do |
| Draft Guidance for Industry: Developing Medical Imaging Drugs and Biologics | October 1998 | Do | Do |
| Guidance for Industry: on Advisory Committees: Implementing Section 120 of the Food and Drug Administration Act of 1997 | October 1998 | Do | Do |
| Draft Document: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 | December 1997 (Released November 1998) | Do | Do |
| Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products | November 1998 | Do | Do |
| To Viral Vaccine IND Sponsors—Use of PCR-based Reverse Transcriptase Assay | December 18, 1998 | Do | Do |
| Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products | December 1998 | Do | Do |
| Draft Guidance for Industry: Content and Format of Geriatric Labeling | December 1998 | Do | Do |
| Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling | January 1999 | Do | Do |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product | January 1999 | Do | Do |
| Guidance on Amended Procedures for Advisory Panel Meetings | January 1999 | Do | Do |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations | January 1999 | Do | Do |
| Guidance for Industry: Population Pharmacokinetics | February 1999 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products | February 1999 | Do | Do |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products | February 1999 | Do | Do |
| Draft Guidance for Industry: INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry Manufacturing and Controls Content and Format | February 1999 | Do | Do |
| Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional Materials | March 1999 | Do | Do |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product | March 1999 | Do | Do |
| Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans | April 1999 | Do | Do |
| Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test | April 1999 | Do | Do |
| Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use” | May 1999 | Do | Do |
| Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products | May 1999 | Do | Do |
| Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use | May 1999 | Do | Do |
| Draft Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing | May 1999 | Do | Do |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation | May 1999 | Do | Do |
| Draft Guidance for Industry: Establishing Pregnancy Registries | June 1999 | Do | Do |
| Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome Data | June 1999 | FDA Personnel | Do |
| Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of donor Test Results for Antibody to HCV (Anti-HCV) | June 1999 | FDA Regulated Industry | Do |
| ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) | June 25, 1999 | Do | Do |
| Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) | July 1999 | Do | Do |
| Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations | July 1999 | Do | Do |
| Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics | August 1999 | Do | Do |
| Guidance for Industry: Consumer-Directed Broadcast Advertisements | August 1999 | Do | Do |
| Draft Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act | August 1999 | Do | Do |
| Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products | August 1999 | Do | Do |
| Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications | August 1999 | Do | Do |
| ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | August 18, 1999 | Do | Do |
| Draft Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors | September 1999 | Do | Do |
| Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act | September 1999 | Do | Do |
| International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical Trials | September 24, 1999 | Do | Do |
| Draft Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors | November 1999 | Do | Do |
| Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format—Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]—Revised | November 1999 | Do | Do |
| Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products | November 1999 | Do | Do |
| Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis and Recommendations for Dosing and Labeling | November 1999 | Do | Do |
| Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma | November 1999 | Do | Do |
| Draft Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling | November 1999 | Do | Do |
| International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document | November 8, 1999 | Do | Do |
| Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 | December 1999 | Do | Do |
| Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts | December 1999 | Do | Do |
| Draft Guidance for Industry: Special Protocol Assessment | December 1999 | Do | Do |
| Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture | January 2000 | Do | Do |
| Draft Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol | February 2000 | FDA Personnel | Do |
| Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information | February 2000 | FDA Regulated Industry | Do |
| Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products | February 2000 | Do | Do |
| Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level | February 2000 | Do | Do |
| Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing | February 2000 | Do | Do |
| Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank | March 2000 | Do | Do |
| International Conference on Harmonisation; E11: Clinical Investigation of Medicinal Products in the Pediatric Population | April 12, 2000 | Do | Do |
| International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products | April 21, 2000 | Do | Do |
III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet) |
|---|---|---|---|
| Accelerated Approval Products—Submission of Promotional Materials | March 26, 1999 | Advertising Draft | http://www.fda.gov/cder/guidance/index.htm |
| Product Name, Placement, Size, and Prominence in Advertising and Promotional Labeling | March 12, 1999 | Do | Do |
| Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) | January 5, 1998 | Do | Do |
| Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling | January 12, 1998 | Advertising | Do |
| Consumer-Directed Broadcast Advertisements | August 9, 1999 | Do | Do |
| Antifungal (topical) | February 24, 1990 | Biopharmaceutic Draft | Do |
| Antifungal (vaginal) | February 24, 1990 | Do | Do |
| Average, Population, and Individual Approaches to Establishing Bioequivalence | August 27, 1999 | Do | Do |
| Bioanalytical Methods Validations for Human Studies | January 5, 1999 | Do | Do |
| Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action | June 2, 1999 | Do | Do |
| Bioavailability and Bioequivalence Studies for Orally Administered Drug Products | August 27, 1999 | Do | Do |
| Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence | March 9, 2000 | Do | Do |
| Food-Effect Bioavailability and Bioequivalence Studies | December 20, 1997 | Do | Do |
| Topical Dermatological Drug Product NDA's and ANDA's—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies | June 18, 1998 | Do | Do |
| Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients | February 17, 1999 | Do | Do |
| Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing | May 15, 1998 | Biopharmaceutic | Do |
| Cholestyramine Powder In Vitro Bioequivalence | July 15, 1993 | Do | Do |
| Cimetidine Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing | June 12, 1992 | Do | Do |
| Clozapine (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing | November 15, 1996 | Do | Do |
| Corticosteroids, Dermatologic (topical) In Vivo | June 2, 1995 | Do | Do |
| Diclofenac Sodium (tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing | October 6, 1994 | Do | Do |
| Dissolution Testing of Immediate Release Solid Oral Dosage Forms | August 25, 1997 | Do | Do |
| Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations | September 26, 1997 | Do | Do |
| Glipizide (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing | April 23, 1993 | Do | Do |
| Glyburide Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing | April 23, 1993 | Do | Do |
| Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro | June 27, 1989 | Do | Do |
| Oral Extended (Controlled) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution Testing | September 9, 1993 | Do | Do |
| Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing | March 4, 1994 | Do | Do |
| Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing | June 6, 1994 | Do | Do |
| Statistical Procedure for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design | July 1, 1992 | Do | Do |
| BACPAC I: Intermediates in Drug Substance Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation) | November 30, 1998 | Chemistry Draft | Do |
| IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information | February 4, 2000 | Do | Do |
| IND's for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls Content and Format | April 20, 1999 | Do | Do |
| Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation | November 19, 1998 | Do | Do |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing | June 24, 1999 | Do | Do |
| Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products | June 2, 1999 | Do | Do |
| Stability Testing of Drug Substances and Drug Products | June 8, 1998 | Do | Do |
| Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications | November 1, 1991 | Do | Do |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum | January 5, 1999 | Do | Do |
| Tracking of NDA and ANDA Reformulations for Solid, Oral, Immediate Release Drug Products | Do | Do | |
| Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products | July 24, 1997 | Chemistry | Do |
| Changes to an Approved NDA or ANDA | November 23, 1999 | Do | Do |
| Container Closure Systems for Packaging Human Drugs and Biologics | July 7, 1999 | Do | Do |
| Drug Master Files | September 1, 1989 | Do | Do |
| Drug Master Files for Bulk Antibiotic Drug Substances | November 29, 1999 | Do | Do |
| Environmental Assessment of Human Drugs and Biologics Applications | July 27, 1998 | Do | Do |
| FDA's Policy Statement for the Development of New Stereoisomeric Drugs | May 1, 1992 | Do | Do |
| Format and Content for the CMC Section of an Annual Report | September 1, 1994 | Do | Do |
| Format and Content of the Chemistry, Manufacturing and Controls Section of an Application | February 1, 1987 | Do | Do |
| Format and Content of the Microbiology Section of an Application | February 1, 1987 | Do | Do |
| NDAs: Impurities in Drug Substances | February 25, 2000 | Do | Do |
| PAC-ALTS: Postapproval Changes—Analytical Testing Laboratory Sites | April 28, 1998 | Do | Do |
| Reviewer Guidance: Validation of Chromatographic Methods | November 1, 1994 | Do | Do |
| Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances | November 1, 1994 | Do | Do |
| Submission of Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug Products | November 1, 1994 | Do | Do |
| Submitting Documentation for the Manufacturing of and Controls for Drug Products | February 1, 1987 | Do | Do |
| Submitting Documentation for the Stability of Human Drugs and Biologics | February 1, 1987 | Do | Do |
| Submitting Samples and Analytical Data for Methods Validation | February 1, 1987 | Do | Do |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances | February 1, 1987 | Do | Do |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances | February 1, 1987 | Do | Do |
| SUPAC IR- Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post- Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing | November 30, 1995 | Do | Do |
| SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum | February 26, 1999 | Do | Do |
| SUPAC-IR Questions and Answers | February 18, 1997 | Do | Do |
| SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation | October 6, 1997 | Do | Do |
| SUPAC-SS—Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation | June 13, 1997 | Do | Do |
| Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Clinical Antimicrobial Draft | Do |
| Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Acute Otitis Media; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment | October 18, 1999 | Do | Do |
| Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements | September 1, 1999 | Do | Do |
| Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Complicated Urinary Tract Infections and Pylonephritis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Developing Antimicrobial Drugs-General Considerations for Clinical Trials | July 22, 1998 | Do | Do |
| Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products | February 17, 1997 | Do | Do |
| Lyme Disease; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Nosocomial Pneumonia; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Secondary Bacterial Infections of Acute Bronchitis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Uncomplicated Gonorrhea—Cervical, Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Vuvlovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment | July 22, 1998 | Do | Do |
| Clinical Development and Labeling of Anti-Infective Drug Products | October 26, 1992 | Clinical Antimicrobial | Do |
| Clinical Evaluation of Anti-Infective Drugs (Systemic) | September 1, 1977 | Do | Do |
| Preclinical Development of Antiviral Drugs | November 1, 1990 | Do | Do |
| Abuse Liability Assessment | July 1, 1990 | Clinical Medical Draft | Do |
| Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) | July 15, 1999 | Do | Do |
| Clinical Evaluation of Anti-Anginal Drugs | January 1, 1989 | Do | Do |
| Clinical Evaluation of Anti-Arrhythmic Drugs | July 1, 1985 | Do | Do |
| Clinical Evaluation of Antihypertensive Drugs | May 1, 1988 | Do | Do |
| Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure | December 1, 1987 | Do | Do |
| Clinical Evaluation of Drugs for Ulcerative Colitis (3rd draft) | Do | Do | |
| Clinical Evaluation of Lipid-Altering Agents in Adults and Children | September 1, 1990 | Do | Do |
| Clinical Evaluation of Motility-Modifying Drugs | Do | Do | |
| Clinical Evaluation of Weight-Control Drugs | September 24, 1996 | Do | Do |
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review | November 22, 1996 | Do | Do |
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review | October 13, 1998 | Do | Do |
| Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders | February 12, 1992 | Do | Do |
| Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis | June 14, 2000 | Do | Do |
| Establishing Pregnancy Registries | June 4, 1999 | Do | Do |
| Evaluation of Human Pregnancy Outcome Data | June 4, 1999 | Do | Do |
| Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment | May 19, 2000 | Do | Do |
| In Vivo Pharmacokinetics and Bioavailability Studies and In Vitro Dissolution Testing for Levothyroxine Sodium Tablets | June 10, 1999 | Do | Do |
| Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research | March 30, 2000 | Do | Do |
| Levothyroxine Sodium | August 18, 1999 | Do | Do |
| OTC Treatment of Herpes Labialis with Antiviral Agents | March 8, 2000 | Do | Do |
| Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis | April 1, 1994 | Do | Do |
| Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals | September 1, 1991 | Do | Do |
| System Inflammatory Response Syndrome (SIRS) 1st Draft | Do | Do | |
| Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) | February 17, 1999 | Clinical Medical | Do |
| Clinical Development Programs for MDI and DPI Drug Products | September 19, 1994 | Do | Do |
| Clinical Evaluation of Analgesic Drugs | December 1, 1992 | Do | Do |
| Clinical Evaluation of Antacid Drugs | April 1, 1978 | Do | Do |
| Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children) | April 1, 1988 | Do | Do |
| Clinical Evaluation of Antianxiety Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antidepressant Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antidiarrheal Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Antiepileptic Drugs (adults and children) | January 1, 1981 | Do | Do |
| Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women | March 20, 1995 | Do | Do |
| Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of General Anesthetics | May 1, 1982 | Do | Do |
| Clinical Evaluation of Hypnotic Drugs | September 1, 1977 | Do | Do |
| Clinical Evaluation of Laxative Drugs | April 1, 1978 | Do | Do |
| Clinical Evaluation of Local Anesthetics | May 1, 1982 | Do | Do |
| Clinical Evaluation of Psychoactive Drugs in Infants and Children | July 1, 1979 | Do | Do |
| Clinical Evaluation of Radiopharmaceutical Drugs | October 1, 1981 | Do | Do |
| Content and Format for Pediatric Use Supplements | May 24, 1996 | Do | Do |
| Content and Format of Investigational New Drug Applications (IND's) for Phase Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products | November 20, 1995 | Do | Do |
| Development of Vaginal Contraceptive Drugs (NDA) | April 19, 1995 | Do | Do |
| FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products | February 2, 1999 | Do | Do |
| FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer | January 21, 1991 | Do | Do |
| FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer | June 20, 1989 | Do | Do |
| Format and Content of the Clinical and Statistical Sections of an Application | July 1, 1988 | Do | Do |
| Format and Content of the Summary for New Drug and Antibiotic Applications | February 1, 1987 | Do | Do |
| Formatting, Assembling and Submitting New Drug and Antibiotic Applications | February 1, 1987 | Do | Do |
| General Considerations for the Clinical Evaluation of Drugs | February 1, 1978 | Do | Do |
| General Considerations for the Clinical Evaluation of Drugs in Infants and Children | September 1, 1977 | Do | Do |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer | April 13, 1988 | Do | Do |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer | April 19, 1988 | Do | Do |
| OTC Treatment of Hypercholesterolemia | October 27, 1997 | Do | Do |
| Postmarketing Adverse Experience Reporting for Human Drugs and Licensed Biological Products; Clarification of What to Report | August 27, 1997 | Do | Do |
| Postmarketing Reporting of Adverse Drug Experiences | March 1, 1992 | Do | Do |
| Preclinical Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated Disorders | September 4, 1992 | Do | Do |
| Preparation of Investigational New Drug Products (Human and Animal) | November 1, 1992 | Do | Do |
| Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products | May 15, 1998 | Do | Do |
| Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs | July 22, 1993 | Do | Do |
| Study of Drugs Likely to be Used in the Elderly | November 1, 1989 | Do | Do |
| Submission of Abbreviated Reports and Synopses in Support of Marketing Applications | September 13, 1999 | Do | Do |
| General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products | November 30, 1998 | Clinical Pharmacology Draft | Do |
| Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro | April 7, 1997 | Clinical Pharmacology | Do |
| Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application | February 1, 1987 | Do | Do |
| In Vivo Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling | November 24, 1999 | Do | Do |
| Pharmacokinetics and Pharmacodynamics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling | May 15, 1998 | Do | Do |
| Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling | December 7, 1999 | Do | Do |
| Population Pharmacokinetics | February 10, 1999 | Do | Do |
| Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production | November 30, 1998 | Compliance Draft | Do |
| Manufacture, Processing or Holding of Active Pharmaceutical Ingredients | April 17, 1998 | Do | Do |
| Repackaging of Solid Oral Dosage Form Drug Products | February 1, 1992 | Do | Do |
| A Review of FDA's Implementation of the Drug Export Amendments of 1986 | Compliance | Do | |
| Compressed Medical Gases | February 1, 1989 | Do | Do |
| Computerized Systems Used in Clinical Trials | May 10, 1999 | Do | Do |
| Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron | June 27, 1997 | Do | Do |
| General Principles of Process Validation | May 1, 1987 | Do | Do |
| Good Laboratory Practice Regulations Questions and Answers | Do | Do | |
| Monitoring of Clinical Investigations | January 1, 1988 | Do | Do |
| Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment | May 1, 1984 | Do | Do |
| Possible Dioxin/PCB Contamination of Drug and Biological Products | August 23, 1999 | Do | Do |
| Sterile Drug Products Produced by Aseptic Processing | May 1, 1987 | Do | Do |
| Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices | December 1, 1987 | Do | Do |
| Regulatory Submissions in Electronic Format; General Considerations | January 28, 1999 | Electronic Submissions | Do |
| Regulatory Submissions in Electronic Format; New Drug Applications | January 28, 1999 | Do | Do |
| ANDA's: Blend Uniformity Analysis | August 26, 1999 | Generic Drug Draft | Do |
| ANDA's: Impurities in Drug Products | January 5, 1999 | Do | Do |
| Abbreviated New Drug Application (ANDA)—Positron Emission Tomography (PET) Drug Products—With specific information for ANDA's for Fludeoxyglucose F18 Injection | April 18, 1997 | Do | Do |
| ANDA's: Impurities in Drug Substances | December 3, 1999 | Generic Drug | Do |
| Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past | August 18, 1995 | Do | Do |
| Letter describing efforts by the CDER & the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process | October 14, 1994 | Do | Do |
| Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy | April 8, 1994 | Do | Do |
| Letter on the provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters | July 1, 1992 | Do | Do |
| Letter on the provision of new procedures and policies affecting the generic drug review process | March 15, 1989 | Do | Do |
| Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions | November 8, 1991 | Do | Do |
| Letter on the response to December 20, 1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act | March 26, 1985 | Do | Do |
| Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse to file incomplete submissions as required by the new law | January 15, 1993 | Do | Do |
| Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirements | August 4, 1993 | Do | Do |
| Major, Minor, Facsimile, and Telephone Amendments to Original Abbreviated New Drug Applications (Revised) | May 1, 2000 | Do | Do |
| Organization of an ANDA | March 2, 1999 | Do | Do |
| Revising ANDA Labeling Following Revision of the RLD Labeling | April 25, 2000 | Do | Do |
| Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products | February 3, 2000 | Do | Do |
| Variations in Drug Products that May Be Included in a Single ANDA | January 27, 1999 | Do | Do |
| E10—Choice of Control Group in Clinical Trials | September 24, 1999 | ICH Draft—Efficacy | Do |
| E11 Clinical Investigation of Medicinal Products in the Pediatric Population | April 12, 2000 | Do | Do |
| M4 Common Technical Document: Request for comments on Initial Components | February 11, 2000 | ICH Draft—Joint Safety/Efficacy | Do |
| Q1A(R) Stability Testing of New Drug Substances and Products | April 21, 2000 | ICH Draft—Quality | Do |
| Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | November 25, 1997 | Do | Do |
| E1A The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions | March 1, 1995 | ICH—Efficacy | Do |
| E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | March 1, 1995 | Do | Do |
| E2B Data Elements for Transmission of Individual Case Safety Reports | January 15, 1998 | Do | Do |
| E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs | May 19, 1997 | Do | Do |
| E3 Structure and Content of Clinical Study Reports | July 17, 1996 | Do | Do |
| E4 Dose-Response Information to Support Drug Registration | November 9, 1994 | Do | Do |
| E5 Ethnic Factors in the Acceptability of Foreign Clinical Data | June 10, 1998 | Do | Do |
| E6 Good Clinical Practice: Consolidated Guideline | May 9, 1997 | Do | Do |
| E7 Studies in Support of Special Populations: Geriatrics | August 2, 1994 | Do | Do |
| E8 General Considerations for Clinical Trials | December 24, 1997 | Do | Do |
| E9 Statistical Principles for Clinical Trials | September 16, 1998 | Do | Do |
| M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals | November 25, 1997 | ICH—Joint Safety/Efficacy | Do |
| Q1A Stability Testing of New Drug Substances and Products | September 22, 1994 | ICH—Quality | Do |
| Q1B Photostability Testing of New Drug Substances and Products | May 16, 1997 | Do | Do |
| Q1C Stability Testing for New Dosage Forms | May 9, 1997 | Do | Do |
| Q2A Text on Validation of Analytical Procedures | May 1, 1995 | Do | Do |
| Q2B Validation of Analytical Procedures: Methodology | May 19, 1997 | Do | Do |
| Q3A Impurities in New Drug Substances | January 4, 1996 | Do | Do |
| Q3B Impurities in New Drug Products | May 19, 1997 | Do | Do |
| Q3C Impurities: Residual Solvents | December 24, 1997 | Do | Do |
| Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin | September 24, 1998 | Do | Do |
| Q5B Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products | February 23, 1996 | Do | Do |
| Q5C Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products | July 10, 1996 | Do | Do |
| Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products | September 21, 1998 | Do | Do |
| Q6B—Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | August 18, 1999 | Do | Do |
| S1A The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals | March 1, 1996 | ICH—Safety | Do |
| S1B Testing for Carcinogenicity in Pharmaceuticals | February 23, 1998 | Do | Do |
| S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals | March 1, 1995 | Do | Do |
| S1C(R) Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes | December 4, 1997 | Do | DO |
| S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals | December 4, 1997 | Do | Do |
| S2B Genotoxicity: Standard Battery Testing | November 21, 1997 | Do | Do |
| S3A Toxicokinetics: The Assessment of systemic Exposure in Toxicity Studies | March 1, 1995 | Do | Do |
| S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies | March 1, 1995 | Do | Do |
| S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) | June 25, 1999 | Do | Do |
| S5A Detection of Toxicity to Reproduction for Medicinal Products | September 22, 1994 | Do | Do |
| S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility | April 5, 1996 | Do | Do |
| S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | November 18, 1997 | Do | Do |
| A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval Inspections | July 15, 1996 | Industry Letters | o |
| Certification Requirements for Debarred Individuals in Drug Applications | July 27, 1992 | Do | Do |
| Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program | June 1, 1990 | Do | Do |
| Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required | April 10, 1987 | Do | Do |
| Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I | October 31, 1986 | Do | Do |
| Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance | October 11, 1984 | Do | Do |
| Implementation Plan USP injection nomenclature | October 2, 1995 | Do | Do |
| Instructions for Filing Supplements Under the Provisions of SUPAC-IR | April 11, 1996 | Do | Do |
| Seventh of a series of letters about the Act providing guidance on the “180-day exclusivity” provision of section 505(j)(4)(B)(iv) of the FD&C | July 29, 1988 | Do | Do |
| Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act | April 22, 1988 | Do | Do |
| Streamlining Initiatives | December 24, 1996 | Do | Do |
| Supplement to 10/11/84 letter about policies, procedures and implementation of the Act (Q & A format) | November 16, 1984 | Do | Do |
| Third of a series of letters regarding the implementation of the Act | May 1, 1985 | Do | Do |
| Content and Format for Geriatric Labeling | January 21, 1999 | Labeling Draft | Do |
| Non-Contraceptive Estrogen Drug Products— Physician and Patient Labeling | January 8, 1999 | Do | Do |
| Noncontraceptive Estrogen Class Labeling | September 27, 1999 | Do | Do |
| OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) | July 16, 1998 | Do | Do |
| Therapeutic Equivalence Code Placement on Prescription Drug Labels and Labeling | January 28, 1999 | Do | Do |
| Acetaminophen and Codeine Phosphate Oral Solution/Suspension | December 1, 1993 | Labeling | Do |
| Acetaminophen and Codeine Phosphate Tablets/Capsules | December 1, 1993 | Do | Do |
| Acetaminophen, Aspirin and Codeine Phosphate Tablets/Capsules | December 1, 1993 | Do | Do |
| Alprazolam Tablets USP | August 1, 1996 | Do | Do |
| Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP | September 1, 1997 | Do | Do |
| Amlodipine Besylate Tablets | September 1, 1997 | Do | Do |
| Astemizole Tablets | September 1, 1997 | Do | Do |
| Atenolol Tablets USP | August 1, 1997 | Do | Do |
| Barbiturate, Single Entity-Class Labeling | March 1, 1981 | Do | Do |
| Butalbital, Acetaminophen and Caffeine Capsules/Tablets USP | September 1, 1997 | Do | Do |
| Butalbital, Acetaminophen, Caffeine and Hydocodone Bitartrate Tablets | September 21, 1997 | Do | Do |
| Butorphanol Tartrate Injection USP | October 1, 1992 | Do | Do |
| Captopril and Hydrochlorothiazide Tablets USP | April 1, 1995 | Do | Do |
| Captopril Tablets | February 1, 1995 | Do | Do |
| Carbidopa and Levodopa Tablets USP | February 1, 1992 | Do | Do |
| Chlordiazepoxide Hydrochloride Capsules | January 1, 1988 | Do | Do |
| Cimetidine Hydrochloride Injection | September 1, 1995 | Do | Do |
| Cimetidine Tablets | September 1, 1995 | Do | Do |
| Cisapride Oral Suspension | September 1, 1997 | Do | Do |
| Cisapride Tablets | September 1, 1997 | Do | Do |
| Clindamycin Phosphate Injection USP | September 1, 1998 | Do | Do |
| Clorazepate Dipotassium Capsules/Tablets | March 1, 1993 | Do | Do |
| Combination Oral Contraceptives—Physician and Patient Labeling | January 1, 1994 | Do | Do |
| Cyproheptadine Hydrochloride Tablets/Syrup | December 1, 1986 | Do | Do |
| Diclofenac Sodium Delayed-Release Tablets | January 1, 1997 | Do | Do |
| Diltiazem Hydrochloride Extended-Release Capsules | September 1, 1995 | Do | Do |
| Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP | April 1, 1995 | Do | Do |
| Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP | April 1, 1995 | Do | Do |
| Dipivefrin Hydrochloride Ophthalmic Solution, 0.1% | November 2, 1998 | Do | Do |
| Ergoloid Mesylates Tablets | January 1, 1988 | Do | Do |
| Fludeoxyglucose F18 Injection | January 1, 1997 | Do | Do |
| Flurbiprofen Tablets USP | January 1, 1994 | Do | Do |
| Fluvoxamine Maleate Tablets | September 1, 1997 | Do | Do |
| Gentamicin Sulfate Ophthalmic Ointment and Solution USP | April 1, 1992 | Do | Do |
| Heparin Sodium Injection USP | March 1, 1991 | Do | Do |
| Hydrocodone Bitartrate and Acetaminophen Tablets USP | April 1, 1994 | Do | Do |
| Hydroxyzine Hydrochloride Injection | December 1, 1989 | Do | Do |
| Hypoglycemic Oral Agents—Federal Register | April 1, 1984 | Do | Do |
| Indomethacin Capsules USP | September 1, 1995 | Do | Do |
| Informal Labeling Guidance Texts for Estrogen Drug Products—Patient Labeling | August 1, 1992 | Do | Do |
| Informal Labeling Guidance Texts for Estrogen Drug Products—Professional Labeling | August 1, 1992 | Do | Do |
| Isoetharine Inhalation Solution | March 1, 1989 | Do | Do |
| Itraconazole Capsules, USP | September 1, 1998 | Do | Do |
| Leucovorin Calcium for Injection | July 1, 1996 | Do | Do |
| Leucovorin Calcium Tablets, USP | July 1, 1996 | Do | Do |
| Local Anesthetics—Class Labeling | September 1, 1982 | Do | Do |
| Meclofenamate Sodium Capsules | July 1, 1992 | Do | Do |
| Medroxyprogesterone Acetate Tablets, USP | September 1, 1998 | Do | Do |
| Metaproterenol Sulfate Inhalation Solution USP | May 1, 1992 | Do | Do |
| Metaproterenol Sulfate Syrup USP | May 1, 1992 | Do | Do |
| Metaproterenol Sulfate Tablets | May 1, 1992 | Do | Do |
| Metoclopramide Tablets USP/Oral Solution | February 1, 1995 | Do | Do |
| Naphazoline Hydrochloride Ophthalmic Solution | March 1, 1989 | Do | Do |
| Naproxen Sodium Tablets, USP | September 1, 1997 | Do | Do |
| Naproxen Tablets, USP | September 1, 1997 | Do | Do |
| Niacin Tablets | July 1, 1992 | Do | Do |
| Paclitaxel Injection | February 1, 1991 | Do | Do |
| Phendimetrazine Tartrate Capsules/Tablets, and Extended-Release Capsules | February 1, 1991 | Do | Do |
| Phentermine Hydrochloride Capsules/Tablets | August 1, 1988 | Do | Do |
| Promethazine Hydrochloride Tablets | March 1, 1990 | Do | Do |
| Propantheline Bromide Tablets | August 1, 1988 | Do | Do |
| Pyridoxine Hydrochloride Injection | June 1, 1984 | Do | Do |
| Quinidine Sulfate Tablets/Capsules USP | October 1, 1995 | Do | Do |
| Ranitidine Tablets USP | November 1, 1993 | Do | Do |
| Risperidone Oral Solution | September 1, 1997 | Do | Do |
| Risperidone Tablets | September 1, 1997 | Do | Do |
| Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension and Ointment | January 1, 1995 | Do | Do |
| Sulfacetamide Sodium Ophthalmic Solution/Ointment | August 1, 1992 | Do | Do |
| Sulfamethoxazole and Phenazopyridine Hydrochloride Tablets | February 1, 1992 | Do | Do |
| Sulfamethoxazole and Trimethoprim Tablets and Oral Suspension | August 1, 1993 | Do | Do |
| Theophylline Immediate-Release Dosage Forms | February 1, 1995 | Do | Do |
| Theophylline Intravenous Dosage Forms | September 1, 1995 | Do | Do |
| Thiamine Hydrochloride Injection | February 1, 1988 | Do | Do |
| Tobramycin Sulfate Injection USP | May 1, 1993 | Do | Do |
| Venlafaxine Hydrochloride Tablets | October 1, 1997 | Do | Do |
| Verapamil Hydrochloride Tablets | October 1, 1991 | Do | Do |
| Vitamin A Capsules | February 1, 1992 | Do | Do |
| Zolpidem Tartrate Tablets | September 1, 1997 | Do | Do |
| Labeling OTC Human Drug Products Using a Column Format | December 1, 1997 | OTC Draft | Do |
| OTC Actual Use Studies | July 22, 1994 | Do | Do |
| OTC Nicotine Substitutes | March 1, 1994 | Do | Do |
| Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) | |||
| General Guidelines for OTC Combination Products | Do | Do | |
| Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) | Do | Do | |
| Photosafety Testing | January 10, 2000 | Pharmacology/Toxicology Draft | Do |
| Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application | February 1, 1987 | Pharmacology/Toxicology | Do |
| Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives | Do | Do | |
| Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies | February 1, 1989 | Do | Do |
| Single Dose Acute Toxicity Testing Toxicity Testing for Pharmaceuticals | August 26, 1996 | Do | Do |
| Applications Covered by Section 505(b)(2) | December 8, 1999 | Procedural Draft | Do |
| Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products | March 10, 2000 | Do | Do |
| Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000 | December 22, 1999 | Do | Do |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank | March 29, 2000 | Do | Do |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act | August 17, 1999 | Do | Do |
| Special Protocol Assessment | February 9, 2000 | Do | Do |
| Submitting Debarment Certification Statements | October 2, 1998 | Do | Do |
| 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | July 14, 1998 | Procedural | Do |
| Advisory Committees: Implementing Section 120 of the Food and Drug Modernization Act of 1997 | November 2, 1998 | Do | Do |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | March 30, 2000 | Do | Do |
| Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 | November 30, 1999 | Do | Do |
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act | November 23, 1998 | Do | Do |
| Fast Track Drug Development Programs: Designation, Development, and Application Review | November 18, 1998 | Do | Do |
| Formal Dispute Resolution: Appeals Above the Division Level | March 7, 2000 | Do | Do |
| Formal Meetings With Sponsors and Applicants For PDUFA Products | March 7, 2000 | Do | Do |
| Implementation of Section 126 of the FDA Modernization Act of 1997—Elimination of Certain Labeling Requirements | July 21, 1998 | Do | Do |
| National Uniformity for Nonprescription Drugs Ingredient Labeling for OTC Drugs | April 9, 1998 | Do | Do |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act—Revised | October 1, 1999 | Do | Do |
| Refusal to File | July 12, 1993 | Do | Do |
| Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act | June 15, 1998 | Do | Do |
| Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements | May 15, 1998 | Do | Do |
| Street Drug Alternatives | April 3, 2000 | Do | Do |
| Women and Minorities Guidance Requirements | July 28, 1998 | Do | Do |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act | August 17, 1999 | User Fee Draft | Do |
| Classifying Resubmissions in Response to Action Letters | May 14, 1998 | User Fee | Do |
| Submitting and Reviewing Complete Responses to Clinical Holds | May 14, 1998 | Do | Do |
IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet) |
|---|---|---|---|
| Compliance Program Guidance Manual: Inspection of Medical Devices; Draft | August 12, 1999 | Office of Compliance (OC) | Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or (FAX) Facts-on-Demand at 1-800-899-0381 or Internet at http://www.fda.gov/cdrh/ggpmain.html |
| Procedures for Laboratory Compliance Testing of Television Receivers-part of TV Packet | May 1, 1986 | Do | Do |
| A Pocket Guide to Device GMP Inspections-Inspections of Medical Device Manufacturers and GMP Regulation Requirements | November 1, 1991 | Do | Do |
| General Principles of Software Validation; Draft Guidance | June 9, 1997 | Do | Do |
| Global Harmonization Task Force Study Group 3-Process Validation Guidance; Final Draft | February 1, 1999 | Do | Do |
| Civil Money Penalty Policy; Guidance for FDA Staff | June 8, 1999 | Do | Do |
| Guidance on Medical Device Tracking; Guidance for Industry and FDA Staff [FDAMA] | January 24, 2000 | Do | Do |
| Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance-Not for Implementation; Guidance for Industry and for FDA Staff | February 8, 2000 | Do | Do |
| Cover Letter/Guidance Document on the Performance Standard for Electrode Lead Wires and Patient Cable | March 9, 1998 | Do | Do |
| Commercial Distribution/Exhibit Letter | April 10, 1992 | Do | Do |
| Working Draft of the Current Good Manufacturing Practice (CGMP) Final Rule | July 1, 1995 | Do | Do |
| Regulating In Vitro Diagnostic Device (IVD) Studies; Guidance; Guidance for FDA Staff | December 17, 1999 | Office of Compliance (OC)/Division of Bioresearch Monitoring (DBM) | Do |
| Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects | March 19, 1999 | Do | Do |
| A Guide for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units with an Attachment for Mandible Work that Holds a Cassette and Beam Limiting Device | March 1, 1996 | Office of Compliance (OC)/Division of Enforcement I (DOEI) | Do |
| A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems | March 1, 1996 | Do | Do |
| A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | March 1, 1996 | Do | Do |
| Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) | March 1, 1989 | Do | Do |
| CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981 Retention of Records Required by 21 CFR 1002 | August 24, 1981 | Do | Do |
| Exemption from Reporting and Recordkeeping Requirements for Certain Sunlamp Product Manufacturers | September 16, 1981 | Do | Do |
| Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-ray Equipment; Guidance for FDA Staff | March 15, 2000 | Do | Do |
| Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry | October 18, 1999 | Do | Do |
| Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables | November 15, 1999 | Do | Do |
| Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components | January 1, 1982 | Do | Do |
| Guideline for the Manufacture of In Vitro Diagnostic Products | January 10, 1994 | Do | Do |
| Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) | May 17, 1993 | Do | Do |
| Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) | October 13, 1993 | Do | Do |
| Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)- E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems | August 1, 1995 | Office of Compliance (OC)/Division of Enforcement I & III (DOEI & III) | Do |
| Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products | August 1, 1995 | Do | Do |
| Guide for Filing Annual Reports for X-Ray Components and Systems | July 1, 1980 | Do | Do |
| Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use | September 1, 1996 | Do | Do |
| Guide for Preparing Product Reports for Medical Ultrasound Products | September 1, 1996 | Do | Do |
| Guide for Preparing Reports on Radiation Safety of Microwave Ovens | March 1, 1985 | Do | Do |
| Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10 | April 1, 1971 | Do | Do |
| Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service Manuals | October 31, 1988 | Do | Do |
| Reporting and Compliance Guide for Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance | October 1, 1995 | Do | Do |
| Reporting Guide for Laser Light Shows and Displays (21 CFR 1002) (FDA 88-8140) | September 1, 1995 | Do | Do |
| Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) | September 1, 1995 | Do | Do |
| All U.S. Condom Manufacturers, Importers and Repackagers | April 7, 1987 | Office of Compliance (OC)/Division of Enforcement II (DOEII) | Do |
| Compliance Guide for Laser Products (FDA 86-8260) | September 1, 1985 | Do | Do |
| Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on April 8, 1987) | April 8, 1987 | Do | Do |
| Dental Handpiece Sterilization (Dear Doctor Letter) | September 28, 1992 | Do | Do |
| Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure | June 23, 1978 | Do | Do |
| Guidance on Quality System Regulation Information for Various Premarket Submissions; Guidance for Industry; Draft | August 3, 1999 | Do | Do |
| Guidance on Quality System Regulation Information for Various Premarket Submissions; Guidance for Industry; Draft | August 3, 1999 | Do | Do |
| Guide for Preparing Product Reports for Lasers and Products Containing Lasers | September 1, 1995 | Do | Do |
| Hazards of Volume Ventilators and Heated Humidifiers | September 15, 1993 | Do | Do |
| Latex Labeling Letter (Johnson) | March 18, 1993 | Do | Do |
| Letter—Condom Manufacturers and Distributors | April 5, 1994 | Do | Do |
| Letter—Manufacturers, Distributors and Importers of Condom Products | February 23, 1994 | Do | Do |
| Letter—Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) | February 13, 1989 | Do | Do |
| Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist | May 28, 1981 | Do | Do |
| Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson | May 10, 1993 | Do | Do |
| Letter to Manufacturers/Repackers Using Cotton | April 22, 1994 | Do | Do |
| Letter to: Manufacturers and Users of Lasers for Refractive Surgery [excimer] | October 10, 1996 | Do | Do |
| Manufacturers and Initial Distributors of Hemodialyzers | May 23, 1996 | Do | Do |
| Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals | February 3, 1994 | Do | Do |
| Pesticide Regulation Notice 94-4: Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA | June 30, 1994 | Do | Do |
| Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device [form FDA 3147] | July 1, 1998 | Office of Compliance (OC)/Division of Enforcement III (DOEIII) | Do |
| Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes | May 1, 1992 | Do | Do |
| Design Control Guidance for Medical Device Manufacturers | March 11, 1997 | Do | Do |
| Final Design Control Report and Guidance | June 1, 1998 | Do | Do |
| Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | February 1, 1975 | Do | Do |
| Guide for Preparing Annual Reports for Ultrasonic Therapy Products | September 1, 1996 | Do | Do |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82-8127) | September 1, 1995 | Do | Do |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (replaces FDA 82-8127) | September 1, 1995 | Do | Do |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) | October 1, 1987 | Do | Do |
| Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only) | August 1, 1996 | Do | Do |
| Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR 1002) | September 1, 1995 | Do | Do |
| Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10 | April 30, 1974 | Do | Do |
| Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137) | September 1, 1980 | Do | Do |
| Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10 | March 1, 1973 | Do | Do |
| Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems | September 1, 1984 | Do | Do |
| Impact Resistant Lenses: Questions and Answers (FDA 87-4002) | September 1, 1987 | Do | Do |
| Keeping Medical Devices Safe from Electromagnetic Interference | July 1, 1995 | Do | Do |
| Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160) | March 1, 1990 | Do | Do |
| Laser Light Show Safety—Who's Responsibility (FDA 86-8262) | May 1, 1986 | Do | Do |
| Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven Miswiring | March 28, 1980 | Do | Do |
| Letter to Trade Association: ReUse of Single-use or Disposable Medical Devices | December 27, 1995 | Do | Do |
| Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products | August 21, 1986 | Do | Do |
| Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations | Do | Do | |
| Medical Devices and EMI: The FDA Perspective | January 1, 1995 | Do | Do |
| Policy on Lamp Compatability (sunlamps) | September 2, 1986 | Do | Do |
| Policy on Warning Label Required on Sunlamp Products | June 25, 1985 | Do | Do |
| Quality Assurance Guidelines for Hemodialysis Devices | February 1, 1991 | Do | Do |
| Quality Control Guide for Sunlamp Products (FDA 88-8234) | March 1, 1988 | Do | Do |
| Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard | May 1, 1980 | Do | Do |
| Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) | September 1, 1995 | Do | Do |
| Reporting of New Model Numbers to Existing Model Families | June 14, 1983 | Do | Do |
| Safety of Electrically Powered Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo | September 18, 1996 | Do | Do |
| Shielded Trocars and Needles used for Abdominal Access during Laparoscopy | August 23, 1996 | Do | Do |
| Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Pub No. 83-8220) | January 1, 1982 | Do | Do |
| Unsafe Patient Lead Wires and Cables | September 3, 1993 | Do | Do |
| Imports: Radiation-Producing Electronic Products (FDA 89-8008) | November 1, 1988 | Do | Do |
| Guidance for Industry on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval | August 5, 1999 | Office of Compliance (OC)/Division of Program Operations (DOP) | Do |
| Letter to Medical Device Manufacturer on Pentium Processors | February 14, 1995 | Office of Compliance (OC)/Office of the Center Director (OCD) | Do |
| Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [510(k)] [CPG 7124.19] | September 24, 1987 | Do | Do |
| Letter to Industry, Powered Wheelchair/Scooter or Accessory/ Component Manufacturer from Susan Alpert, Ph.D.,M.D. | May 26, 1994 | Office of the Center Director (OCD)/Office of Device Evaluation (ODE) | Do |
| General/Specific Intended Use; Guidance for Industry; Final | November 4, 1998 | Do | Do |
| ODE Executive Secretary Guidance Manual | August 7, 1987 | Do | Do |
| Preamendments Class III Strategy; SXAlpert | April 19, 1994 | Do | Do |
| Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA] | February 19, 1998 | Do | Do |
| “Real-Time” Review Program for Premarket Approval Application (PMA) Supplements | April 22, 1997 | Office of Device Evaluation (ODE) | Do |
| 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final | February 19, 1998 | Do | Do |
| 510(k) Quality Review Program (Blue Book Memo) | March 29, 1996 | Do | Do |
| Convenience Kits Interim Regulatory Guidance (include 874) | May 20, 1997 | Do | Do |
| Determination of Intended Use for 510(k) Devices Guidance for Industry and CDRH Staff [FDAMA]; Final | January 30, 1998 | Do | Do |
| Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; Final | October 10, 1997 | Do | Do |
| Document Review by the Office of the Chief Counsel (Blue Book Memo G96-1)) | June 6, 1996 | Do | Do |
| Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Guidance for Industry, Draft | August 6, 1998 | Do | Do |
| Contents of Product Development Protocol; Guidance for Industry, Draft | July 27, 1998 | Do | Do |
| Frequently Asked Questions on The New 510(k) Paradigm; Guidance for Industry; Final | October 22, 1998 | Do | Do |
| Evidence Models for the Least Burdensome Means to Market; Guidance for Industry and FDA Reviewers; Draft | September 1, 1999 | Do | Do |
| Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final | May 20, 1998 | Do | Do |
| New Model Medical Device Development Process; Guidance for Industry; Final | July 21, 1998 | Do | Do |
| Guidance for Off-the-Shelf Software Use in Medical Devices; Final | September 9, 1999 | Do | Do |
| Guidance for Submitting Reclassification Petition | June 1, 1989 | Do | Do |
| Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA]; Final | January 26, 1999 | Do | Do |
| Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—For Use by CDRH & Industry [FDAMA]; Final | February 19, 1998 | Do | Do |
| Guidance on the Use of Standards in Substantial Equivalence Determinations; Final | March 12, 2000 | Do | Do |
| PMA Shell Development and Modular Review; Guidances for the Medical Device Industry; Final | November 6, 1998 | Do | Do |
| New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff [FDAMA]; Final | February 19, 1998 | Do | Do |
| Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final | February 19, 1998 | Do | Do |
| SMDA Changes-Premarket Notification; Regulatory Requirements for Medical Devices [510(k)] Manual Insert | April 17, 1992 | Do | Do |
| The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final | March 20, 1998 | Do | Do |
| 4-of-A-Kind PMA's | October 1, 1991 | Do | Do |
| Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices | December 1, 1983 | Do | Do |
| CDRH Submissions Coversheet [PMA/PDP/510k/IDE] | May 8, 1998 | Do | Do |
| CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File Policies | June 30, 1993 | Do | Do |
| Classified Convenience Kits | April 30, 1993 | Do | Do |
| Color Additive Petitions (p. II-19 of PMA Manual) | June 1, 1987 | Do | Do |
| Color Additive Status List (Inspection Operations Manual) | February 1, 1989 | Do | Do |
| Color Additives for Medical Devices (Snesko) | November 15, 1995 | Do | Do |
| Deciding When to Submit a 510(k) for a Change to an Existing Device | January 10, 1997 | Do | Do |
| Device Specific Guidance Documents (List) | May 11, 1993 | Do | Do |
| FDA Guide for Validation of Biological Indicator Incubation Time | January 1, 1986 | Do | Do |
| FDA Policy For The Regulation Of Computer Products (DRAFT) | November 13, 1989 | Do | Do |
| Format for IDE Progress Reports | June 1996 | Do | Do |
| Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final | May 29, 1998 | Do | Do |
| Guidance for Preparation of PMA Manufacturing Information | August 1, 1992 | Do | Do |
| Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) | March 1, 1988 | Do | Do |
| Guideline for the Monitoring of Clinical Investigations | January 1, 1988 | Do | Do |
| Guideline on General Principles of Process Validation | May 1, 1987 | Do | Do |
| Guideline on Sterile Drug Products Produced by Aseptic Processing | June 1, 1987 | Do | Do |
| Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test | December 1, 1987 | Do | Do |
| Indications for Use Statement | January 2, 1996 | Do | Do |
| Industry Representatives on Scientific Panels | March 27, 1987 | Do | Do |
| Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance | April 1, 1996 | Do | Do |
| Limulus Amebocyte Lysate; Reduction of Samples for Testing | October 23, 1987 | Do | Do |
| Master Files Part III; Guidance on Scientific and Technical Information | June 1, 1987 | Do | Do |
| Electromagnetic Compatibility for Medical Devices: Issues and Solutions; Memorandum | June 13, 1995 | Do | Do |
| Methods for Conducting Recall Effectiveness Checks | June 16, 1978 | Do | Do |
| Necessary Information for Diagnostic Ultrasound 510(k) (Draft) | November 24, 1987 | Do | Do |
| PMA Review Schedule [P87-1] | March 31, 1988 | Do | Do |
| Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products (from John C. Petricciani, M.D.) | June 1, 1984 | Do | Do |
| Preamendment Class III Devices | March 11, 1992 | Do | Do |
| Premarket Notification [510(k)] Status Request Form, revised | March 14, 1997 | Do | Do |
| Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) | September 1, 1989 | Do | Do |
| Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated June 25, 1993 Device “Fast Track” Plan Announcement (include with 926 930) | June 30, 1993 | Do | Do |
| Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities | September 3, 1996 | Do | Do |
| Shelf Life of Medical Devices | March 1, 1991 | Do | Do |
| Substantial Equivalence (SE) Decision Making Documentation ATTACHED: “SE” Decision Making Process (Detailed), i.e., the decision making tree | January 1, 1990 | Do | Do |
| Suggested Content for Original IDE Application Cover Letter—Version 4 | February 27, 1996 | Do | Do |
| Suggestions for Submitting a Premarket Approval (PMA) Application | April 1, 1993 | Do | Do |
| Threshold Assessment of the Impact of Requirements for Submission of PMA's for 31 Medical Devices Marketed Prior to May 28, 1976 | January 1, 1990 | Do | Do |
| Interagency Agreement between FDA & HCFA; #D95-2, Attachment A | September 15, 1995 | Office of Device Evaluation (ODE)/BlueBook | Do |
| Criteria for Categorization of Investigational Devices (HCFA); #D95-2, Attachment B | September 15, 1995 | Do | Do |
| Deciding When to Submit a 510(k) for a Change to an Exisiting Device; Blue Book Memo #K97-1 | January 10, 1997 | Do | Do |
| 510(k) Additional Information Procedures #K93-1 (Blue Book Memo) | July 23, 1993 | Do | Do |
| 510(k) Refuse to Accept Procedures #K94-1 (Blue Book Memo) | May 20, 1994 | Do | Do |
| 510(k) Sign-Off Procedures #K94-2 (Blue Book Memo) | June 3, 1994 | Do | Do |
| 510(k) Sterility Review Guidance and Revision of November18/1994 #K90-1 (Blue Book Memo) | February 12, 1990 | Do | Do |
| Announcement: Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices #D95-2 (Blue Book Memo) | September 15, 1995 | Do | Do |
| Assignment of Review Documents #I90-2 (Blue Book Memo) | August 24, 1990 | Do | Do |
| Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy | June 30, 1993 | Do | Do |
| Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy—(updated Checklist March 14, 1995) | June 30, 1993 | Do | Do |
| Clinical Utility and Premarket Approval #P91-1 (Blue Book Memo) | May 3, 1991 | Do | Do |
| Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo) | October 19, 1990 | Do | Do |
| Consolidated Review of Submissions for Lasers and Accessories #G90-1 (Blue Book Memo) | October 19, 1990 | Do | Do |
| Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) | July 15, 1996 | Do | Do |
| Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo #K95-1) | November 21, 1995 | Do | Do |
| Criteria for Panel Review of PMA Supplements #P86-3 (Blue Book Memo) | January 30, 1986 | Do | Do |
| Delegation of IDE Actions #D88-1 (Blue Book Memo) | April 26, 1988 | Do | Do |
| Device Labeling Guidance #G91-1 (Blue Book Memo) | March 8, 1991 | Do | Do |
| Document Review Processing #I91-1 (Blue Book Memo) | February 12, 1992 | Do | Do |
| Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (Blue Book Memo) | December 23, 1993 | Do | Do |
| Executive Secretaries Guidance Manual #G87-3 | August 7, 1987 | Do | Do |
| Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo) | July 12, 1995 | Do | Do |
| Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (Blue Book Memo) | June 30, 1986 | Do | Do |
| HCFA Reimbursement Categorization Determinations for FDA-approved IDEs | October 31, 1995 | Do | Do |
| IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo) | May 20, 1994 | Do | Do |
| Integrity of Data and Information Submitted to ODE #I91-2 (Blue Book Memo) | May 29, 1991 | Do | Do |
| Meetings with the Regulated Industry #I89-3 (Blue Book Memo) | November 20, 1989 | Do | Do |
| Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3)) | August 9, 1996 | Do | Do |
| Nondisclosure of Financially Sensitive Information #I92-1 (Blue Book Memo) | March 5, 1992 | Do | Do |
| ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures #G87-2 (Blue Book Memo) | May 15, 1987 | Do | Do |
| Overdue IDE Annual Progress Report Procedures #D93-1 (Blue Book Memo) | July 23, 1993 | Do | Do |
| Panel Report and Recommendations on PMA Approvals #P86-5 (Blue Book Memo) | April 18, 1986 | Do | Do |
| Panel Review of “Me-Too” Devices #P86-6 (Blue Book Memo) | July 1, 1986 | Do | Do |
| Panel Review of Premarket Approval Applications #P91-2 (Blue Book Memo) | May 3, 1991 | Do | Do |
| PMA Compliance Program #P91-3 (Blue Book Memo) | May 3, 1991 | Do | Do |
| PMA Filing Decisions #P90-2 (Blue Book Memo) | May 18, 1990 | Do | Do |
| PMA Refuse to File Procedures #P94-1 (Blue Book Memo) | May 20, 1994 | Do | Do |
| PMA Supplements: ODE letter to manufacturers; identifies situations which may require the submission of a PMA supplement (When PMA Supplements are Required) #P90-1 (Blue Book Memo) | April 24, 1990 | Do | Do |
| PMA/510(k) Triage Review Procedures #G94-1 (Blue Book Memo) | May 20, 1994 | Do | Do |
| PMA's—Early Review and Preparation of Summaries of Safety and Effectiveness #P86-1 (Blue Book Memo) | January 27, 1986 | Do | Do |
| Policy Development and Review Procedures #I90-1 (Blue Book Memo) | February 15, 1990 | Do | Do |
| Premarket Approval Application (PMA) Closure #P94-1 (Blue Book Memo) | July 8, 1994 | Do | Do |
| Premarket Notification—Consistency of Reviews #K89-1 (Blue Book Memo) | February 28, 1989 | Do | Do |
| Review and Approval of PMA's of Licensees #P86-4 (Blue Book Memo) | October 22, 1990 | Do | Do |
| Review of 510(k)s for Computer Controlled Medical Devices #K91-1 (Blue Book Memo) | August 29, 1991 | Do | Do |
| Review of Final Draft Medical Device Labeling #P91-4 (Blue Book Memo) | August 29, 1991 | Do | Do |
| Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo) | May 17, 1989 | Do | Do |
| Review of Laser Submissions #G88-1 (Blue Book Memo) | April 15, 1988 | Do | Do |
| Telephone Communications Between ODE Staff and Manufacturers #I93-1 (Blue Book Memo) | January 29, 1993 | Do | Do |
| Toxicology Risk Assessment Committee #G89-1 (Blue Book Memo) | August 9, 1989 | Do | Do |
| Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” (Replaces #G87-1 #8294) (Blue Book Memo) | May 1, 1995 | Do | Do |
| Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery | February 20, 1996 | Office of Device Evaluation (ODE)/Division of Clinical Laboratory Devices (DCLD) | Do |
| Letter to IVD Manufacturers on Streamlined PMA; Final | December 22, 1997 | ||
| Assessing the Safety/Effectiveness of Home-use In Vitro Diagnostic Devices (IVD's): Points to Consider Regarding Labeling and Premarket Submissions; Draft | October 1, 1988 | Do | Do |
| Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers | June 10, 1996 | Do | Do |
| Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies; Draft | August 31, 1995 | Do | Do |
| Guidance Document for 510(k) Submission of Fecal Occult Blood Tests; Draft | July 29, 1992 | Do | Do |
| Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft | September 30, 1991 | Do | Do |
| Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft | September 1, 1992 | Do | Do |
| Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies; Draft | September 26, 1991 | Do | Do |
| Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) that are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft | October 8, 1999 | Do | Do |
| Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft | June 14, 1993 | Do | Do |
| Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) with Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; Draft | September 10, 1992 | Do | Do |
| Guidance Criteria for Cyclosporine PMA's | January 24, 1992 | Do | Do |
| Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDA | September 19, 1996 | Do | Do |
| Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use | July 14, 1995 | Do | Do |
| Guidance for Industry—Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | February 22, 1999 | Do | Do |
| Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s] Guidance for Industry; Final | April 28, 1999 | Do | Do |
| Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used By The Consumer; Guidance for Industry; Draft | December 30, 1998 | Do | Do |
| Guidance on Labeling for Laboratory Tests; Guidance for Industry; Draft | June 24, 1999 | Do | Do |
| In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Guidance for Industry; Final | July 6, 1998 | Do | Do |
| In Vitro Diagnostic Chloride Test System; Guidance for Industry; Final | July 6, 1998 | Do | Do |
| In Vitro Diagnostic C-Reactive Protein Immunological Test System; Guidance for Industry; Final | July 20, 1998 | Do | Do |
| In Vitro Diagnostic Creatinine Test System; Guidance for Industry; Final | July 2, 1998 | Do | Do |
| In Vitro Diagnostic Glucose Test System; Guidance for Industry ; Final | July 6, 1998 | Do | Do |
| Guidance for Industry—In Vitro Diagnostic Potassium Test System; Final | July 6, 1998 | Do | Do |
| In Vitro Diagnostic Sodium Test System; Guidance for Industry; Final | July 6, 1998 | Do | Do |
| In Vitro Diagnostic Urea Nitrogen Test System; Guidance for Industry; Final | July 6, 1998 | Do | Do |
| Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Guidance for Industry; | February 3, 1999 | Do | Do |
| In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Guidance for Industry and FDA Reviewers/Staff; Final | April 27, 1999 | Do | Do |
| Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Draft | December 21, 1999 | Do | Do |
| Guidance for Submission of Immunohistochemistry Applications to the FDA | June 3, 1998 | Do | Do |
| Points to Consider for Cervical Cytology Devices | July 25, 1994 | Do | Do |
| Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance | September 26, 1994 | Do | Do |
| Points to Consider for Hematology Quality Control Materials | September 30, 1997 | Do | Do |
| Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated March 14/1996 | February 1, 1996 | Do | Do |
| Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies | July 15, 1994 | Do | Do |
| Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; Draft | March 8, 2000 | Do | Do |
| Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs | October 30, 1996 | Do | Do |
| Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers | July 15, 1991 | Do | Do |
| Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) | September 27, 1995 | Do | Do |
| Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. Tuberculosis [(TB)] | July 6, 1993 | Do | Do |
| Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens | January 1, 1992 | Do | Do |
| Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori | September 17, 1992 | Do | Do |
| Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology | February 14, 1996 | Do | Do |
| Review Criteria for Assessment of Rheumatoid Factor(RF) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry | February 21, 1997 | Do | Do |
| Review Criteria for Blood Culture Systems | August 12, 1991 | Do | Do |
| Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases | May 31, 1990 | Do | Do |
| Review Criteria for Devices Intended for the Detection of Hepatitis B “e” Antigen and Antibody to Hbe | December 30, 1991 | Do | Do |
| Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents | August 1, 1992 | Do | Do |
| Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA). | February 1, 1994 | Do | Do |
| Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) | February 15, 1996 | Do | Do |
| Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 | May 15, 1992 | Do | Do |
| Review Criteria for the Assessment of Allergen-Specific Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test Methodologies | March 2, 1993 | Do | Do |
| Review Criteria for the Assessment of Anti-nuclear Antibodies (ANA) In-Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA). | September 1, 1992 | Do | Do |
| Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions | February 21, 2000 | Office of Device Evaluation (ODE)/Division of Cardiovascular, Respiratory & Neurological Devices (DCRND) | Do |
| Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application | January 1, 1989 | Do | Do |
| Battery Guidance | July 12, 1993 | Do | Do |
| Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications | October 26, 1996 | Do | Do |
| Coronary and Cerebrovascular Guidewire Guidance | January 1, 1995 | Do | Do |
| 510(K) Submission Requirements for Peak Flow Meters; Draft | January 13, 1994 | Do | Do |
| Emergency Resuscitator Guidance; Draft | April 14, 1993 | Do | Do |
| Guidance for Implantable Cardioverter-Defibrillators; Draft | June 24, 1996 | Do | Do |
| Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses; Draft | August 1, 1993 | Do | Do |
| Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft | May 1, 1995 | Do | Do |
| Guidance: Human Heart Valve Allografts; Draft | June 21, 1991 | Do | Do |
| Intravascular Brachytherapy—Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft | May 24, 1996 | Do | Do |
| Percutaneous Transluminal Coronary Angioplasty Package Insert Template; Draft | February 7, 1995 | Do | Do |
| Replacement Heart Valve Guidance; Draft | October 14, 1994 | Do | Do |
| Reviewer Guidance for Ventilators; Draft | July 1, 1995 | Do | Do |
| Reviewer Guidance on Face Masks and Shield for CPR; Draft | March 16, 1994 | Do | Do |
| Cardiac Ablation Preliminary Guidance (Data to be Submitted to the FDA in Support Investigation Device Exemption Application; Draft | March 1, 1995 | Do | Do |
| Electrode Recording Catheter Preliminary Guidance (Data to be Submitted to the FDA in Support of Premarket Notifications [510(k)s]) ; Draft | March 1, 1995 | Do | Do |
| Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch/EMC Standard for Medical Devices (to be used with EMI Standard) | November 1, 1993 | Do | Do |
| General Guidance Document: Non-Invasive Pulse Oximeter | September 7, 1992 | Do | Do |
| Guidance Document: Electrocardiograph (ECG) Surface Electrode Tester—Version 1.0 | February 11, 1997 | Do | Do |
| Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final | January 24, 2000 | Do | Do |
| Guidance Document for Vascular Prostheses 510(k) Submission; Final | November 26, 1999 | Do | Do |
| Guidance for Annuloplasty Rings 510(k) Submissions; Final | November 26, 1999 | Do | Do |
| Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final | February 21, 2000 | Do | Do |
| Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final | January 17, 2000 | Do | Do |
| Guidance for Cardiovascular Intravascular Filter 510(k) Submission; Final | November 26, 1999 | Do | Do |
| Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final | February 16, 2000 | Do | Do |
| Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Guidance for Industry; Final | November 5, 1998 | Do | Do |
| Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Guidance for Industry; Final | November 5, 1998 | Do | Do |
| Recommended Clinical Study Design for Ventricular Tachycardia Ablation; Guidance for Industry and for FDA Reviewers | May 7, 1999 | Do | Do |
| Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II | February 1, 1989 | Do | Do |
| Guidance for Peak Flow Meters for Over-the-Counter Sale | June 23, 1992 | Do | Do |
| Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve Prostheses | April 1, 1990 | Do | Do |
| Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Electrode Version 1.0 | February 11, 1997 | Do | Do |
| Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Lead Switching Adapter Version 1.0 | February 11, 1997 | Do | Do |
| Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final | January 14, 2000 | Do | Do |
| Heated Humidifier Review Guidance | August 30, 1991 | Do | Do |
| Implantable Pacemaker Testing Guidance | January 12, 1990 | Do | Do |
| Vascular Graft Manufacturer, Developer, or Representative; Letter/Guidance | May 11, 1990 | Do | Do |
| Medical Device Labeling—Suggested Format and Content; Draft Document | April 25, 1997 | Do | Do |
| Non-Invasive Blood Pressure (NIBP) Monitor Guidance | March 10, 1997 | Do | Do |
| Policy for Expiration Dating (DCRND RB92-G) | October 30, 1992 | Do | Do |
| Review Guidelines for Oxygen Generators and Oxygen Equipment; Draft Document | April 14, 1993 | Do | Do |
| Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators | October 1, 1993 | Do | Do |
| Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators | November 9, 1990 | Do | Do |
| Reviewer's Guidance for Oxygen Concentrator | August 30, 1991 | Do | Do |
| Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Draft | November 16, 1999 | Office of Device Evaluation (ODE)/Division of Dental, Infection Control and General Hospital Devices (DDIGD) | Do |
| Devices for the Treatment and/or Diagnosis of Temporomandibular Joint Dysfunction and/or Orofacial Pain; Final | June 10, 1998 | Do | Do |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submission of Washers and Washer-Disinfectors; Draft | November 5, 1998 | Do | Do |
| Guidance Document for Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices | June 2, 1998 | Do | Do |
| Overview of Information Necessary for Premarket Notification Submissions for Endoseous Implants; Final | April 21, 1999 | Do | Do |
| Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft | February 8, 2000 | Do | Do |
| Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities; Addendum | September 19, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)'S] for Dental Alloys; Draft | March 3, 1997 | Do | Do |
| Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick); Draft | March 1, 1995 | Do | Do |
| Guidance and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants; Final | January 3, 2000 | Do | Do |
| Guidance Document on Dental Handpieces | July 1, 1995 | Do | Do |
| Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final | January 13, 1999 | Do | Do |
| Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices; (Addendum to Premarket Notification [510(k) Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final) | July 27, 1997 | ||
| Neonatal and Neonatal Transport Incubators-Premarket Notifications; Guidance for Industry and FDA Reviewers; Final | September 18, 1998 | Do | Do |
| Dental Cements Premarket Notification; Final | August 18, 1998 | Do | Do |
| Guidance For The Arrangement and Content of a Premarket Approval (PMA) Application For An Endosseous Implant For Prosthetic Attachment | May 16, 1989 | Do | Do |
| Guidance for the Preparation of a Premarket Notification [510(k)] for Direct Filling Dental Composites | November 27, 1998 | Do | Do |
| Guidance for the Preparation of Premarket Notification [510(k)] for Resorbable Periodontal Barriers | April 1991 | Do | Do |
| Guidance on 510(k) Submissions for Implanted Infusion Ports | October 1, 1990 | Do | Do |
| Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities | August 1, 1993 | Do | Do |
| Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters | March 16, 1995 | Do | Do |
| Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities | March 1, 1993 | Do | Do |
| Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes | August 1, 1993 | Do | Do |
| Guidance on the Content and Format of Premarket Notification [510(k)] for Testing for Skin Sensitization to Chemicals in Latex Products [Draize Testing] | February 13, 1998 | Do | Do |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers | October 1, 1993 | Do | Do |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of March 9, 1994) | October 1, 1993 | Do | Do |
| Guidance on the Content and Format of Premarket Notification 510(k) Submissions for Liquid Chemical Germicides | December 6, 1996 | Do | Do |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints | December 1, 1995 | Do | Do |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles | April 1, 1993 | Do | Do |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes | April 1, 1993 | Do | Do |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers | March 1, 1993 | Do | Do |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps | March 1, 1993 | Do | Do |
| Dental Impression Materials Premarket Notification; Final | August 17, 1998 | Do | Do |
| OTC Denture Cushions, Pads, Reliners, Repair Kits and Partially Fabricated Denture Kits; Final | August 18, 1998 | Do | Do |
| Information Necessary for Premarket Notification Submissions For Screw-Type Endossesous Implants | December 9, 1996 | Do | Do |
| 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants | February 20, 1997 | Office of Device Evaluation (ODE)/Division of General & Restorative Devices (DGRD) | Do |
| Alternate Suture Labeling Resulting From the January 11, 1993 Meeting with HIMA (Reformatted December 17, 1997) | January 11, 1993 | Do | Do |
| Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants | February 21, 1997 | Do | Do |
| Copy of October 9, 1992 Letter and Original Suture Labeling Guidance (Reformatted December 17, 1997) | October 9, 1992 | Do | Do |
| 510(k) Guideline for General Surgical Electrosurgical Devices; Draft | May 10, 1995 | Do | Do |
| Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices; Draft | March 28, 1995 | Do | Do |
| Guidance Document for Femoral Stem Prostheses; Draft | August 1, 1995 | Do | Do |
| Guidance Document for Testing Acetabular Cup Prostheses; Draft | May 1, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements; Draft | July 16, 1997 | Do | Do |
| Guidance for Arthroscopes and Accessory 510(k)s; Draft | May 1, 1994 | Do | Do |
| Guidance for Testing MR Interaction with Aneurysm Clips; Draft | May 22, 1996 | Do | Do |
| Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing [510(k)] ; Draft | May 31, 1995 | Do | Do |
| Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD); Draft | August 30, 1994 | Do | Do |
| Guidance for the Preparation of an IDE Submission for a Interactive Wound and Burn Dressing; Draft | April 4, 1995 | Do | Do |
| Guidance for the Preparation of Premarket Notifications [510(k)] s for Cemented, Semi-Constrained Total Knee Prostheses; Draft | April 1, 1993 | Do | Do |
| Outline for a Guidance Document for Testing Orthopedic Bone Cement, request for comments by December 10, 1993; Draft | November 1, 1993 | Do | Do |
| Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators; Draft | June 1, 1994 | Do | Do |
| Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part-3 Implant Model; Draft | September 12, 1994 | Do | Do |
| Biofeedback Devices—Guidance for 510(k) Content; Draft | August 1, 1994 | Do | Do |
| Cranial Perforator Guidance; Draft | July 13, 1994 | Do | Do |
| Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators; Draft | August 20, 1992 | Do | Do |
| Guide for Cortical Electrode 510(k) Content; Draft | August 10, 1992 | Do | Do |
| Neuro Endoscope Guidance; Draft | July 7, 1994 | Do | Do |
| Electroencephalograph Devices Guidance for 510(k) Content; Draft | November 3, 1997 | Do | Do |
| Galvanic Skin Response Measurement Devices-Draft Guidance for 510(k) Content | August 1, 1994 | Do | Do |
| Guidance Document for the Preparation of IDEs for Spinal Systems; Final | January 13, 2000 | Do | Do |
| Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Guidance Document for Industry and CDRH Staff; Draft | March 18, 1998 | Do | Do |
| Guidance Document for Surgical Lamp 510Ks; Final | July 13, 1998 | Do | Do |
| Guidance Document for Testing Biodegradable Polymer Implant Devices; Draft | April 20, 1996 | Do | Do |
| Guidance Document for Testing Bone Anchor Devices; Draft | April 20, 1996 | Do | Do |
| Guidance Document for Testing Non-Articulating, “Mechanically Locked”, Modular Implant Components; Draft | May 1, 1995 | Do | Do |
| Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement (replaces 8623 and 8093) | April 28, 1994 | Do | Do |
| Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices | February 18, 1993 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Beds | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Therapeutic Massagers and Vibrators | July 26, 1995 | Do | Do |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices | July 26, 1995 | Do | Do |
| Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems | January 10, 1995 | Do | Do |
| Guidance Document for Dura Substitute Devices; Final | August 13, 1999 | Do | Do |
| Guidance Document for Neurological Embolization Devices; Guidance for Industry; Final | August 13, 1999 | Do | Do |
| Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Guidance for Industry; Final | August 30, 1999 | Do | Do |
| Guidance for Dermabrasion Devices; Final | March 2, 1999 | Do | Do |
| Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses; Guidance for Industry; Draft | October 5, 1999 | Do | Do |
| Guidance for Spinal System 510(k)s; Final | May 7, 1999 | Do | Do |
| Guidance Document for Powered Suction Pump 510(k)s; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Final | October 30, 1998 | Do | Do |
| Guidance Document for Powered Muscle Stimulator 510(k)s; Guidance for Industry, FDA Reviewers/Staff and Compliance; Final | June 9, 1999 | Do | Do |
| Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Guidance for Industry; Final | April 28, 1998 | Do | Do |
| Guidance for Studies for Pain Therapy Devices—General Considerations in the Design of Clinical Studies for Pain-Alleviating Devices | May 12, 1988 | Do | Do |
| Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final | March 2, 1999 | Do | Do |
| Guidance on the Content and Organization of a Premarket Notification for a Medical Laser | June 1, 1995 | Do | Do |
| Guide for TENS 510(k) Content; Draft | August 1, 1994 | Do | Do |
| Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators | February 1997 | Do | Do |
| Core Study for Silicone Breast Implants; Letter | January 11, 1996 | Do | Do |
| ORDB 510(k) Sterility Review Guidance | July 3, 1997 | Do | Do |
| Protocol for Dermal Toxicity Testing for Devices in Contact with Skin; Draft | January 1985 | Do | Do |
| Reviewers Guidance Checklist for Intramedullary Rods | February 21, 1997 | Do | Do |
| Reviewers Guidance Checklist for Orthopedic External Fixation Devices | February 21, 1997 | Do | Do |
| Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses; Amendment 1; Draft | June 28, 1994 | Office of Device Evaluation (ODE)/Division of Ophthalmic Devices (DOD) | Do |
| Guidance for Premarket Submission of Orthokeratology Rigid Gas Permeable Contact Lenses; Final | April 10, 2000 | Do | Do |
| An FDA Survey of U.S. Contact Lens Wearers (Carol L. Herman) Reprinted from Contact Lens Spectrum | July 1, 1987 | Do | Do |
| Announcement by Dr. Alpert at July 26, 1996 Ophthalmic Panel Meeting concerning Manufacturers & Users of Lasers for Refractive Surgery [Excimer] | August 26, 1996 | Do | Do |
| Announcement: Information for Manufacturers & Users of Lasers for Refractive Surgery [Excimer] | September 22, 1997 | Do | Do |
| Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer] | October 10, 1996 | Do | Do |
| Contact Lenses: The Better the Care the Safer the Wear; Publication No. FDA 91-4220 | April 1, 1991 | Do | Do |
| Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers”; Draft | September 5, 1997 | Do | Do |
| Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses and June 28, 1994 corrections to pages 18 & 20; Draft | May 12, 1994 | Do | Do |
| Premarket Notification 510(k) Guidance for Contact Lens Care Products; Draft | May 1, 1997 | Do | Do |
| Facts for Consumers from the Federal Trade Commission-Eyeglasses | April 1, 1986 | Do | Do |
| FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMA's | May 29, 1997 | Do | Do |
| Ophthalmoscope Guidance (Direct and Indirect); Guidance for Industry | July 8, 1998 | Do | Do |
| Guidance Document for Nonprescription Sunglasses; Final | October 9, 1998 | Do | Do |
| Retinoscope Guidance; Final | July 8, 1998 | Do | Do |
| Slit Lamp Guidance; Final | July 13, 1998 | Do | Do |
| Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Guidance for Industry and FDA Staff; Final | August 11, 1998 | Do | Do |
| Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft | August 4, 1999 | Do | Do |
| Aqueous Shunts—510(k) Submissions; Final | November 16, 1998 | Do | Do |
| Guidance on 510(k) Submissions for Keratoprostheses; Final | March 3, 1999 | Do | Do |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask; Draft | January 16, 1998 | Do | Do |
| Important Information About Rophae Intraocular Lenses | August 20, 1992 | Do | Do |
| Intraocular Lens (IOL) Guidance Document; Draft | October 14, 1999 | Do | Do |
| New FDA Recommendations & Results of Contact Lens Study (7 Day Letter) | May 30, 1989 | Do | Do |
| Owners Certification of Lasers as PMA Approved Devices Excimer] | September 26, 1996 | Do | Do |
| Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification [510(k)] | January 31, 1997 | Do | Do |
| Update on Excimer Lasers for Nearsightedness | May 20, 1996 | Do | Do |
| Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final | March 12, 2000 | Do | Do |
| 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments | September 19, 1994 | Office of Device Evaluation (ODE)/Division of Reproductive, Abdominal, ENT & Radiological Devices (DRAERD) | Do |
| Guidance for Hemodialyzer Reuse Labeling; Draft | November 6, 1995 | Do | Do |
| Content of Premarket Notification for Hemodialysis Delivery Systems; Guidance for Industry and CDRH Reviewers; Final | August 7, 1998 | Do | Do |
| Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi | February 8, 1999 | Do | |
| CDRH Interim Regulatory Policy for External Penile Rigidity Devices | September 10, 1997 | Do | Do |
| Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology | November 1, 1994 | Do | Do |
| 510(k) Checklist for Conditioned Response Enuresis Alarms; Draft | November 23, 1994 | Do | Do |
| 510(k) Checklist for Condom Catheters; Draft | February 23, 1995 | Do | Do |
| 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology; Draft | August 16, 1995 | Do | Do |
| 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology; Draft | June 22, 1995 | Do | Do |
| 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence; Draft | June 6, 1995 | Do | Do |
| 510(k) Checklist for Urological Irrigation System and Tubing Set; Draft | August 1, 1995 | Do | Do |
| Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH); Draft | November 11, 1994 | Do | Do |
| Guidance for Information on Clinical Safety and Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi; Draft | February 5, 1992 | Do | Do |
| Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence; Draft | November 29, 1995 | Do | Do |
| Guidance for Preparation of PMA Applications for Penile Inflatable Implants; Draft | March 16, 1993 | Do | Do |
| Guidance for Preparation of PMA Applications for Testicular Prostheses; Draft | March 16, 1993 | Do | Do |
| Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter); Draft | May 1, 1995 | Do | Do |
| Guidance for Review of Bone Densitometer 510(k) Submissions; Draft | November 9, 1992 | Do | Do |
| Guidance for the Clinical Investigation of Urethral Stents; Draft | November 2, 1995 | Do | Do |
| Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology; Draft | March 17, 1995 | Do | Do |
| Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions; Draft | July 29, 1991 | Do | Do |
| Guidance for the Content of Premarket Notifications for Menstrual Tampons; Draft | May 25, 1995 | Do | Do |
| Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters; Draft | January 24, 1992 | Do | Do |
| Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis; Draft | May 30, 1997 | Do | Do |
| Guidance Outline-Points to Consider for Clinical Studies for Vasovasostomy Devices; Draft | November 30, 1993 | Do | Do |
| Guidance to Firms on Biliary Lithotripsy Studies; Draft | August 2, 1990 | Do | Do |
| Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements; Draft | January 18, 1991 | Do | Do |
| Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); Draft | March 14, 1996 | Do | Do |
| Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft Availability | September 10, 1998 | Do | Do |
| Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Guidance for Industry; Final | November 30, 1998 | Do | Do |
| Guidance (“Guidelines”) for Evaluation of Fetal Clip Electrode | March 8, 1977 | Do | Do |
| Guidance (“Guidelines”) for Evaluation of Hysteroscopic Sterilization Devices | May 10, 1978 | Do | Do |
| Guidance (“Guidelines”) for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) | May 1978 | Do | Do |
| Guidance (“Guidelines”) for Evaluation of Tubal Occlusion Devices | November 22, 1977 | Do | Do |
| Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Guidance for Industry; Final | December 3, 1998 | Do | Do |
| Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Guidance for Industry; Final | November 20, 1998 | Do | Do |
| Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry; Final | November 14, 1998 | Do | Do |
| Harmonic Imaging With/Without Contrast Premarket Notification; Guidance for Industry; Final | November 16, 1998 | Do | Do |
| Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance; Version 1; Guidance for Industry; Final | November 19, 1998 | Do | Do |
| Uniform Contraceptive Labeling; Guidance for Industry; Final | July 23, 1998 | Do | Do |
| Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final | January 16, 2000 | Do | Do |
| Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Guidance for Industry; Draft | August 25, 1999 | Do | Do |
| Noise Claims in Hearing Aid Labeling; Final | October 21, 1998 | Do | Do |
| Guidance for Magnetic Resonance Diagnostic Devices—Criteria for Significant Risk Investigations | September 29, 1997 | Do | Do |
| Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Draft | December 16, 1999 | Do | Do |
| Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years | May 1, 1990 | Do | Do |
| Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices | August 1, 1993 | Do | Do |
| Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology | February 10, 1993 | Do | Do |
| Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters | September 12, 1994 | Do | Do |
| Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final | February 5, 1998 | Do | Do |
| Guidance for the Content of Premarket Notifications for Urethral Stents | February 10, 1993 | Do | Do |
| Guidance for the Content of Premarket Notifications for Urine Drainage Bags | June 7, 1994 | Do | Do |
| Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems | July 29, 1994 | Do | Do |
| Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; Final | August 6, 1999 | Do | Do |
| Guidance for the Technical Content of a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube with Valve | April 1, 1990 | Do | Do |
| Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers; Guidance to Industry and CDRH Reviewers; Final | August 7, 1998 | Do | Do |
| Guideline for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age | May 1, 1990 | Do | Do |
| Guidelines for Evaluation of Non-Drug IUD's | September 28, 1976 | Do | Do |
| Home Uterine Activity Monitors: Guidance for the Submission of 510(k) Premarket Notifications; Draft | July 30, 1999 | Do | Do |
| Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a 510(k) includes 00192 | March 27, 1996 | Do | Do |
| Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) | August 1, 1995 | Do | Do |
| Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; Draft | July 1, 1997 | Do | Do |
| Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft | September 30, 1997 | Do | Do |
| Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft | June 14, 1997 | Do | Do |
| Latex Condoms for Men-Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions | July 23, 1998 | Do | Do |
| Notice to Manufacturers of Bone Mineral Densitometers; Letter | September 25, 1997 | Do | Do |
| Premarket Testing Guidelines for Falloposcopes | November 20, 1992 | Do | Do |
| Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases | April 4, 1990 | Do | Do |
| Reviewer Guidance for Automatic X-Ray Film Processor 510(k) | February 1, 1990 | Do | Do |
| Simplified 510(k) Procedures For Certain Radiology Devices (December 21, 1993 letter from L Yin, ODE/DRAERD, to NEMA) | December 21, 1993 | Do | Do |
| Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems; Status Update | June 19, 1996 | Do | Do |
| Testing Guidance for Male Condoms Made from New Material (Non-Latex) | June 29, 1995 | Do | Do |
| Tympanostomy Tubes Submission Guidance for a 510(k) Premarket Notification; Final | January 14, 1998 | Do | Do |
| Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA] Final | March 20, 1998 | ODE/Program Operations Staff (POS) | Do |
| PMA/510(k) Expedited Review-Guidance for Industry and CDRH Staff [FDAMA] Final | March 20, 1998 | Do | Do |
| PMA/510(k) Expedited Review #G98-4 (Blue Book Memo) | March 20, 1998 | Do | Do |
| Guidance on IDE Policies and Procedures [FDAMA]; Final | January 20, 1998 | Do | Do |
| FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions [FDAMA]; Final | February 6, 1998 | Office of Health and Industry Programs (OHIP) | Do |
| Overview of FDA Modernization Act of 1997 Medical Device Provisions [FDAMA]; Final | June 5, 1998 | Do | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations Document #1; Final | March 4, 1999 | Office of Health and Industry Programs (OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP) | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations Document #2; Final | February 25, 2000 | Do | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Draft | December 8, 1999 | Do | Do |
| Guidance The Mammography Quality Standards Act Final Regulations—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final | May 5, 1999 | Do | Do |
| Guidance The Mammography Quality Standards Act Final Regulations—Preparing for MQSA Inspections; Final | May 5, 1999 | Do | Do |
| Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b); Final | May 4, 1999 | Do | Do |
| Guidance for Review of Cases of Possible Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b); Final | March 26, 1998 | Do | Do |
| Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S. C. 263(b); Final | March 26, 1998 | Do | Do |
| Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b); Final | March 26, 1998 | Do | Do |
| Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies; Final | August 13, 1998 | Do | Do |
| Guidance for Policy and Standard Operating Procedures When Mammography Facilities in States that Have Accreditation Bodies Intend to Change Accreditation Bodies; Final | April 15, 1998 | Do | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations Preparing for MQSA Inspections; Final | May 5, 1999 | Do | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly; Final | March 23, 1999 | Do | Do |
| Guidance: The Mammography Quality Standards Act Final Regulations: Quality Assurance Documentation; Final | December 7, 1999 | Do | Do |
| Premarket Notification: 510(k)-Regulatory Requirements for Medical Devices (FDA 95-4158) [available on disk] | August 1, 1995 | Office of Health and Industry Programs (OHIP)/Division of Small Manufacturers Assistance (DSMA) | Do |
| Labeling-Regulatory Requirements for Medical Devices (FDA 89-4203) | September 1, 1989 | Do | Do |
| Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246) | March 1, 1995 | Do | Do |
| An Introduction to Medical Device Regulations (FDA 92-4222) | January 1, 1992 | Do | Do |
| Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 | November 11, 1996 | Do | Do |
| Medical Glove Guidance Manual; FDA 99-4257; Draft | August 30, 1999 | Do | Do |
| In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97-4224) [available on disk] | January 1, 1997 | Do | Do |
| Instructions for Completion of Medical Device Registration and Listing Forms FDA 2891, 2891a and 2892 | July 1, 1997 | Do | Do |
| Investigational Device Exemptions [IDE] Manual (FDA 96-4159) [available on disk] | June 1, 1996 | Do | Do |
| Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Final | February 19, 1998 | Do | Do |
| Medical Device Reporting for Manufacturers [available on disk] | March 1, 1997 | Do | Do |
| Premarket Approval (PMA) Manual; Final | January 1, 1998 | Do | Do |
| Regulatory Requirements for Devices for the Handicapped (FDA 87-4221) | August 1, 1987 | Do | Do |
| Small Business Guide to FDA (FDA 96-1092) | January 1, 1996 | Do | Do |
| The FDA Export Reform and Enhancement Act of 1996/Export Certification Package including “Instructions for Requests for Certificate to Foreign Governments”; Final | February 7, 2000 | Do | Do |
| U.S.-FDA-Regulation of Medical Devices; Background Information for International Officials (entire document available on disk); Final | April 14, 1999 | Do | Do |
| 510(k) Manual-Premarket Notification: 510(k)-Regulatory Requirements for Medical Devices | August 1, 1995 | Do | Do |
| Export—Foreign Liaison (part of “Exporting Medical Devices,” February 25, 1999) | December 2, 1998 | Do | Do |
| Exporting Medical Devices; Final | February 25, 1999 | Do | Do |
| Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA); Guidance for Staff, Industry, and Third Parties; Final | January 6, 1999 | Do | Do |
| Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Guidance for Staff, Industry, and Third Parties; Final | October 30, 1998 | Do | Do |
| Medical Device Quality Systems Manual: A Small Entity Compliance Guide | December 1, 1996 | Do | Do |
| Do It By Design—An Introduction to Human Factors in Medical Devices | December 1, 1996 | Office of Health and Industry Programs (OHIP)/Division of Device User Programs and Systems Analysis (DUPSA) | Do |
| Guidance on Medical Device Patient Labeling; Guidance for Industry; Draft | March 3, 2000 | Do DUPSA | Do |
| Device Use Safety: Incorporating Human Factors in Risk Management; Guidance For Industry and FDA Premarket and Postmarket Review Staff; Draft | August 3, 1999 | Do DUPSA | Do |
| Human Factors Points to Consider for IDE Devices; Draft | January 17, 1997 | Do DUPSA | Do |
| Human Factors Principles for Medical Device Labeling | September 1, 1993 | Do DUPSA | Do |
| Medical Device Reporting for User Facilities | April 1, 1996 | Do DUPSA | Do |
| Write it Right; Recommendations for Developing User Instruction Manuals for medical Devices Used in Home Health Care | August 1, 1993 | Do | Do |
| Perspectives on Clinical Studies for Medical Device Submissions (Statistical) | Unknown Pre-1997 | Office of Surveillance and Biometrics (OSB)/ | Do |
| PMA Review Statistical Checklist | Unknown Pre-1997 | Do | Do |
| Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes an Appendix the article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions” | June 1, 1984 | Office of Surveillance and Biometrics (OSB)/Division of Biostatistics (DB) | Do |
| Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; Final | March 30, 1994 | Office of Surveillance and Biometrics (OSB)/Issues Management Staff (IMS) | Do |
| Guidance on Procedures for Review of Postmarket Surveillance Submissions [FDAMA]; Final | February 19, 1998 | Do | Do |
| Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies [FDAMA]; Final | February 19, 1998 | Do | Do |
| SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols [FDAMA]; Guidance for Industry and FDA Staff; Final | November 2, 1998 | Do | Do |
| Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads); Final | June 9, 1993 | Do | Do |
| Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements; Guidance for Industry; Final | February 2, 2000 | Office of Surveillance and Biometrics (OSB)/Division of Postmarket Surveillance (DPS) | Do |
| Common Problems: Baseline Reports and Medwatch Form 3500A | January 1997 | Office of Surveillance and Biometrics (OSB)/Division of Surveillance Systems (DSS) | Do |
| Instructions for Completing FDA Form 3500A with Coding Manual for Form 3500A (MEDWATCH) (MDR) | December 15, 1995 | Do | Do |
| MDR Documents Access Information for National Technical Information Service (NTIS) | May 10, 1996 | Do | Do |
| MDR Internet List Server (listserv) Instruction sheet | August 29, 1996 | Do | Do |
| MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR) | June 1, 1993 | Do | Do |
| MDR Reporting Guidance For Breast Implants—E1996002 | August 7, 1996 | Do | Do |
| Addendum to the Instructions for Completing FDA Form 3500A with Coding Manual (MEDWATCH) (MDR) | June 9, 1999 | Do | Do |
| Instructions for Completing Form 3417: Medical Device Reporting Baseline Report MDR] | March 31, 1997 | Do | Do |
| Summary Reporting Approval for Adverse Events; Letter to Manufacturers; Final | July 31, 1997 | Do | Do |
| MDR Guidance Document No. 1—IOL—E1996004 | August 7, 1996 | Do | Do |
| MDR Guidance Document No. 3-Needlestick & Blood Exposure—E1996003 | August 9, 1996 | Do | Do |
| MDR Guidance Document: Remedial Action Exemption—E1996001 | July 30, 1996 | Do | Do |
| MDR Reporting Guidance for Date-Related Problems Including Y2K | April 16, 1999 | Do | Do |
| Medical Device Reporting: An Overview; Final | April 1, 1996 | Do | Do |
| Variance from Manufacturer Report Number Format [MDR letter]; Final | July 16, 1996 | Do | Do |
| A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems; Draft | February 7, 1997 | Office of Science and Technology (OST) | Do |
| Frequently Asked Questions on Recognition of Consensus Standards [FDAMA]; Final | December 21, 1998 | Do | Do |
| Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size Distribution | Unknown pre-1997 | Do | Do |
| Guidance on the Recognition and Use of Consensus Standards/Appendix A [FDAMA]; Final | February 19, 1998 | Do | Do |
| CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition; Final | August 6, 1999 | Do | Do |
| Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final | November 16, 1998 | Do | Do |
| Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problems; Final | May 15, 1998 | Do | Do |
| Guidance on Immunotoxicity Testing; Final | May 6, 1999 | Office of Science and Technology (OST)/Division of Life Sciences (DLS) | Do |
V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How To Obtain A Hard Copy of The Document (Name and Address, Phone, Fax, E-Mail or Internet) |
|---|---|---|---|
| Compliance Policy Guides Manual | 1998 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB96-920500 |
| Compliance Programs Guidance Manual | 1995 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB95-915499 |
| FDA Recall Policy | 1995 | FDA Regulated Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204 |
| Investigators' Operations Manual | May 1996 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB-95-913399 |
| Regulatory Procedures Manual | August 1995 | FDA Regulated Industries | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB95-265534 |
| Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration “Blue Book” | 1997 | FDA Regulated Industries | Superintendent of Documents, Government Printing Office, Washington, DC 20402 |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed | 1995 | Food and Animal Feed Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, PB96-920500 |
| Pesticides Analytical Manual | 1994 | Food Industry | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB94-911899 |
| FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal Feed | September 16, 1993 | Food and Animal Feed Industries | Office of Plant & Dairy Foods & Beverages, Food and Drug Administration (HFS-306), 200 C St. SW., Washington, DC 20204, 202-205-4681 |
| FDA's Cosmetic Labeling Manual | October 1991 | Cosmetic Industry | Food and Drug Administration, Office of Colors and Cosmetics (HFS-105), 200 C St. SW., Washington, DC 20204, 202-205-4493 |
| Statement of Policy: Foods Derived from New Plant Varieties: Notice | May 29, 1992 (57 FR 22984) | Developers of New Plant Food Varieties | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| A Food Labeling Guide | May 1997 | Food Industry | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Appendix I—Model Small Business Food Labeling Exemption Notice | June 1996 | Food Industry | Do |
| Food Labeling: Questions and Answers | August 1994 | Food Industry | Do |
| Food Labeling: Questions and Answers: Volume II | February 1996 | Food Industry | Superintendent of Documents, Government Printing Office, Washington, DC 20420, 202-512-1800 |
| Fair Packaging and Labeling Act Manual | June 1978 | Food Industry | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650, PB-83-222117 |
| Bacteriological Analytical Manual 7th Edition | 1992 | FDA Regulated Industries | AOAC International, 481 N. Frederick Ave., Suite 500, Gaithersburg, MD, 20877-2417, 301-924-7077 |
| FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods | 1985 | Food Industry | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Fabrication of Single Service Containers and Closures for Milk and Milk Products | 1995 | States | Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20202, 202-205-9175 |
| Evaluation of Milk Laboratories | 1995 | States | Do |
| Methods of Making Sanitation Ratings Of Milk Supplies | 1995 | States | Do |
| Dry Milk Ordinance | 1995 | States | Do |
| Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers | 1995 | Dairy Industry | Do |
| Frozen Dessert Processing Guidelines | 1989 | Dairy Industry | Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| Pasteurized Milk Ordinance | 1995 | States | Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition 200 C St. SW., Washington, DC 20204, 202-205-9175 |
| FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases | 1993 | Food Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Guidelines for Determining Metric Equivalents of Household Measures | October 1, 1993 | Food Industry | Do |
| List of Food Defect Action Levels (DALS) | 1995 | Food and Animal Feed Industries | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (Also Found in CPG's) | 1995 | Food and Animal | Do |
| 1997 FDA Food Code | 1997 | States | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650 |
| Seafood List | 1993 | Seafood Industry | Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202-512-1800 |
| Manual of Operations National Shellfish Sanitation | 1992 | States | Office of Seafood, Office of Seafood (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150 |
| Fish and Fisheries Products Hazards and Controls Guide | 1996 | Seafood Industry | Do |
| Guidance for Submitting Requests under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Articles | 1996 | Food Packaging Industry, | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Guidelines for the Preparation of Petition Submissions | 1996 | Food Ingredient or Packaging Industry | Do |
| Guidelines for Approval of Color Additives in Contact Lenses Intended as Colors | 1996 | Color or Contact Lens Industry | Do |
| FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics Use | February 1993 | Color Additives Industry | Do |
| Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations | December 1992 | Food Packaging Industry | Do |
| Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions | May 1993 | Food Packaging Industry | Do |
| Recommendations for Chemistry Data for Indirect Food Additive Petitions | June 1995 | Food Packaging Industry | Do |
| Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions | January 1993 | Food Enzyme Industry | Do |
| Estimating Exposure to Direct Food Additive and Chemical Contaminants in the Diet | September 1995 | Food and Food Ingredient Industry | Do |
| Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I) | 1982 | Petitioners for Food or Color Additives | Do |
| Environmental Assessment Technical Handbook | March 1987 | Petitioners for Food or Color Additives | National Technical Inion Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, Pub. No. PB87175345-AS, Ab-01 |
| Color Additive Petitions Information and Guidance | 1996 | Petitioners for Color Additives | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Toxological Testing of Food Additives | 1983 | Petitioners for Food or Color Additives | Office of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| List of Products for Each Product Category | October 8, 1992 | Food Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers | June 10, 1996 | Food Industry | Do |
| Guidance on Labeling of Foods that Need Refrigeration by Consumers | February 24, 1997 (62 FR 8248) | Food Industry | Do |
| Guidelines Concerning Notification and Testing of Infant Formula | 1985 | Infant Formula Manufacturers | Do |
| Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Term Infants | 1988 | Infant Formula Manufacturers | Do |
| Guidelines for the Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Infants with Allergic Diseases | 1988 | Infant Formula Manufacturers | Do |
| Guidelines for the Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases | 1990 | Infant Formula Manufacturers | Do |
| Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders | 1987 | Infant Formula Manufacturers | Do |
| Guidance Document for Arsenic (Trace Elements in Seafood) | January 1993 | States | Office of Seafood, Food and Drug Administration (HFS-400), 200 C St. SW., Washington, DC 20204, 202-418-3150, Internet: FDA Home Page Http://vm.cfsan.fda.gov/list.html |
| Guidance Document for Cadmium (Trace Elements in Seafood) | January 1993 | States | Do |
| Guidance Document for Chromium (Trace Elements in Seafood) | January 1993 | States | Do |
| Guidance Document for Lead (Trace Elements in Seafood) | August 1993 | States | Do |
| Guidance Document for Nickel (Trace Elements in Seafood) | January 1993 | States | Do |
| FDA's Policy for Foods Developed by Biotechnology | 1995 | Food Industry | Do |
| Bovine Spongiform Encephalopathy (BSE) In Products for Human Use | 1997 | Food Industry | Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home Page Http://www.fda.gov/opacom/morechoices/industry/guidance/gelguide.htm |
| Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin | February 1994 | Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168 |
| Shellfish Sanitation Model Ordinance | 1995 | States | Shellfish Program Implementation Branch, Division of Cooperative Programs Office of Field Programs (HFS-628), 200 C St. SW., Washington, DC 20204, 202-205-8137 |
| Guide to Minimize Microbial Hazards for Fresh Fruits and Vegetables | 1998 | Farmers and Food Packers | Lou Carson, Food Safety Initiative (HFS-3), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 or jsaltsman@bangate.fda.gov |
| Iron-Containing Supplements and Drugs: Label Warning and Unit Dose Packaging; Small Entity Compliance Guide | 1997 | Dietary Supplement Manufacturers: Small Entities | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-450), FDA-CFSAN, 200 C. St. SW., Washington, DC 20204 |
| Partial List of Enzyme Preparations That are Used in Foods | 1998 | FDA Regulated Industry | Do |
| Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food | 1998 | FDA Regulated Industry | Office of Premarket Approval (HFS-200), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 |
| Fish and Fishery Products Hazards and Controls Guide, 2nd Edition | January 1998 | FDA Regulated Industry | Office of Seafood (HFS-400), FDA-CFSAN, 200 C St. SW., Washington DC 20204 |
| HACCP Regulations for Fish and Fishery Products: Questions and Answers | 1998 | FDA Regulated Industry | Do |
| Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body | 1998 | FDA Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204 |
| Small Business Juice Labeling: Questions and Answers | 1998 | Small Business | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204, Geraldine June, 202-205-5099 |
| FDA Nutrition Labeling Manual, A Guide for Developing and Using Data Bases | March 1998 | FDA Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204 |
| HACCP Regulation for Fish and Fishery Products: Questions and Answers, Issue Three, Revised January 1999 | January 1999 | Seafood Processors | Office of Seafood, CFSAN/FDA (HFS-400), 200 C St. SW., Washington, DC 20204, Ellen Nesheim, 202-418-3150 |
| Foods—Adulteration Involving Hard or Sharp Foreign Objects (CPG) | February 1999 | FDA Field Offices | Office of Plant and Dairy Foods and Beverages (HFS-300), 200 C. St. SW., Washington, DC 20204 |
| Food Additive Petition Expedited Review | January 1999 | Guidance for Industry and Center for Food Safety and Applied Nutrition Staff | Robert L. Martin (HFS-215), OPA/CFSAN/FDA, 200 C St. SW., Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov OR http://vm.cfsan.fda.gov/~dms/opa-expe.html |
| Use of Antibiotic Resistance Marker Genes in Transgenic Plants | September 1998 | Guidance for Industry | Nega Beru (HFS-206), OPA/CFSAN/FDA, 200 C. St. SW., Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov OR http://vm.cfsan.fda.gov//dms/ opa-armg.html |
| Draft Guidance: Channels of Trade Policy for Commodities with Methyl Parathion Residues | June 2000 | Regulated Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/dms |
| Draft Guidance: Fumonisin Levels in Human Foods and Animal Feeds | June 2000 | Regulated Industry | Do |
| Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide | January 1999 | Small Business Entities | Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 |
| Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999) | December 1999 | Regulated Industry, | Office of Nutritional Products, Labeling, and Dietary Supplements, Center For Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Antimicrobial Food Additives | July 1999 | Regulated Industry | Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100 |
| Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations | November 1999 | Regulated Industry | Do |
| Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations | November 1999 | Regulated Industry | Do |
| Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking | October 1999 | Small Business Entities | Division of Market Studies (HFS-726), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590 |
| Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide | September 1998 | Regulated Industry | Office of Nutritional Products, Labeling, and Dietary Supplements, Center For Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 |
| Reducing Microbial Food Safety Hazards for Sprouted Seeds | October 1999 | Regulated Industry | Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064 |
| Seafood HACCP Transition Policy | December 1999 | Regulated Industry | Office of Seafood (HFS-400), 200 C St. SW., Washington DC 20204, 202-205-3150 |
VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet) |
|---|---|---|---|
| Guideline 3—General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals | July 1994 | Animal Drug Industry | Internet via: http://www.fda.gov/cvm or Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301-594-1831 |
| Guideline 4—Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle | Do | Do | |
| Guideline 5—Stability Guidelines | December 1990 | Do | Do |
| Guideline 6—Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRC | Do | Do | |
| Guideline 9—Preclearance Guidelines for Production Drugs | October 1975 | Do | Do |
| Guideline 10—Amendment of Section II (G)(1)(b)(4) of the Preclearance Guidelines | October 1975 | Do | Do |
| Guideline 13—Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds | January 1985 | Do | Do |
| Guideline 14—Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing Animals | Do | Do | |
| Guideline 15—Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals | February 1977 | Do | Do |
| Guideline 16—FOI Summary Guideline | May 1985 | Do | Do |
| Guideline 18—Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria | Do | Do | |
| Guideline 19—Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria | Do | Do | |
| Guideline 20—Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria | Do | Do | |
| Guideline 22—Guideline Labeling of Arecoline Base Drugs Intended for Animal Use | Do | Do | |
| Guideline 23—Medicated Free Choice Feeds—Manufacturing Control | July 1985 | Do | Do |
| Guideline 24—Guidelines for Drug Combinations for Use in Animals | October 1983 | Do | Do |
| Guideline 25—Guidelines for the Efficacy Evaluation of Equine Anthelmintics | January 1979 | Do | Do |
| Guideline 29—Guidelines for the Effectiveness Evaluation of Swine Anthelmintics | September 1980 | Do | Do |
| Guideline 31— Guidelines for the Evaluation of Bovine Anthelmintics | July 1981 | Do | Do |
| Guideline 33—Target Animal Safety Guidelines for New Animal Drugs | June 1989 | Do | Do |
| Guideline 35—Bioequivalence Guideline—Final | 1996 | Do | Do |
| Guideline 36—Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics | July 1985 | Do | Do |
| Guideline 37—Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation | March 1984 | Do | Do |
| Guideline 38—Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs | August 1984 | Do | Do |
| Guideline 40—Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry | April 1992 | Do | Do |
| Guideline 41—Draft Guideline: Formatting, Assembling, and Submitting New Animal Drug Applications | June 1992 | Do | Do |
| Guideline 42—Animal Drug Manufacturing Guidelines, 1994 | 1994 | Do | Do |
| Guideline 43—Guidance on Generic Animal Drug Products Containing Fermentation-Derived Drug Substances | October 1995 | Do | Do |
| Guideline 45—Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle | August 1993 | Do | Do |
| Guideline 48—Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products | November 1994 | Do | Do |
| Guideline 49—Guidance Document for Target Animal Safety and Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products | April 1996 | Do | Do |
| Guideline 50—Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products | February 1993 | Do | Do |
| Guideline 52—Guidance—Microbiological Testing of Antimicrobial Drug Residues in Food | January 1996 | Do | Do |
| Guideline 53—Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals | May 1994 | Do | Do |
| Guideline 54—Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds | June 1994 | Do | Do |
| Guideline 55—Supportive Data for Cat Food Labels Bearing “Reduces Urinary pH Claims: Guideline in Protocol Development” | June 1994 | Do | Do |
| Guideline 56—Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials | November 1994 | Do | Do |
| Guideline 57—Master Files—Guidance for Industry for the Preparation and Submission of Veterinary Master Files | July 1995 | Do | Do |
| Guideline 58—Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors | May 1997 | Do | Do |
| Guideline 59—Guidance for Industry: Submitting a Notice of Claimed Investigational Exemption in Electronic Format to CVM via E-Mail | January 1999 | Do | Do |
| Guidance 61—Guidance for Industry—FDA Approval of Animal Drugs for Minor Uses and for Minor Species | January 1999 | Do | Do |
| Guideline 62—Guidance for Industry—Consumer-Directed Broadcast Advertisements | August 1997 | Do | Do |
| Guideline 63—Guidance for Industry—Validation of Analytical Procedures: Definition and Terminology—Draft Guidance | December 1997 | Do | Do |
| Guideline 64—Guidance for Industry—Validation of Analytical Procedures: Methodology—Draft Guidance | December 1997 | Do | Do |
| Guideline 65—Guidance for Industry—Industry-Supported Scientific and Educational Activities | November 1997 | Do | Do |
| Guideline 66—Guidance for Industry— Professional Flexible Labeling of Antimicrobial Drugs—Draft Guidance | January 1998 | Do | Do |
| Guideline 67—Guidance for Industry—Small Entities Compliance Guide for Renderers | February 1998 | Do | Do |
| Guideline 68—Guidance for Industry—Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors | February 1998 | Do | Do |
| Guideline 69—Guidance for Industry—Small Entities Compliance Guide for Feeders of Ruminant Animals With On-Farm Feed Mixing Operations | February 1998 | Do | Do |
| Guideline 70—Guidance for Industry—Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations | February 1998 | Do | Do |
| Guideline 71—Guidance for Industry—Use of Human Chorionic Gonadotropic (HCG) as a Spawning Aid for Fish | April 1998 | Do | Do |
| Guideline 72—Guidance for Industry—GMP's for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDA | May 1998 | Do | Do |
| Guideline 73—Draft Guidance for Industry—Stability Testing of New Animal Drug Substances and Products | July 1998 | Do | Do |
| Guideline 74—Draft Guidance for Industry—Stability Testing for New Dosage Forms of New Animal Drugs | July 1998 | Do | Do |
| Guideline 75—Guidance for Industry—Stability Testing: Photostability Testing of New Animal Drug Substances and Products: Draft Guidance | July 1998 | Do | Do |
| Guideline 76—Guidance for Industry—Questions and Answers—BSE Feed Regulation | September 1998 | Do | Do |
| Guideline 77—Guidance for Industry—Interpretation of On-Farm Feed Manufacturing and Mixing Operations—Draft Guidance | September 1998 | Do | Do |
| Guideline 78—Guidance for Industry—Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals | December 1999 | Do | Do |
| Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA: Draft Guidance | June 1999 | Do | Do |
| Draft Guidance for Industry: Good Clinical Practices | July 1999 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: General Recommendations: Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Stability Testing for Medicated Premixes Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Impurities in New Veterinary Drug Substances Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Impurities in New Veterinary Medical Products Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Bovines: Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Ovines: Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry—Validation of Analytical Procedures: Definition and Terminology | July 1999 | Do | Do |
| Guidance for Industry—Validation of Analytical Procedures: Methodology: Final Guidance | July 1999 | Do | Do |
| Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Caprines: Draft Guidance | July 1999 | Do | Do |
| Guidance for Industry: Manufacture and Distribution of Unapproved Piperazine Products | August 1999 | Do | Do |
| Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products | August 1999 | Do | Do |
| Guidance for Industry—Consumer-Directed Broadcast Advertisements: Final Guidance | August 1999 | Do | Do |
| Guidance for Industry: Stability Testing of New Veterinary Dosage Forms VICH GL4: Final Guidance | September 1999 | Do | Do |
| Guidance for Industry: Stability Testing of New Veterinary Drug Substances and Medicinal Products VICH GL3: Final Guidance | September 1999 | Do | Do |
| Guidance for Industry: Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)—Phase I: Draft Guidance | September 1999 | Do | Do |
| Guidance for Industry: Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products VICH GL 17: Draft Guidance | September 1999 | Do | Do |
| Guidance for Industry: Impurities: Residual Solvents VICH GL 18: Draft Guidance | September 1999 | Do | Do |
| Guidance for Industry—Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Non-Food Animals | September 1999 | Do | Do |
| Guidance for Industry: Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products: Final Guidance | September 1999 | Do | Do |
| Computerized Systems Used in Clinical Trials | October 1999 | Do | Do |
| Dioxin in Anti-Caking Agents Used in Animal Feed and Feed Ingredients | October 1999 | Do | Do |
| Guidance for Industry—Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals | December 1999 | Do | Do |
| Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs—Draft Guidance | January 2000 | Do | Do |
| Guidance for Industry: Stability Testing for Medicated Premixes Guidance | March 2000 | Do | Do |
| Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval—Draft Guidance | April 11, 2000 | Do | Do |
| Guidance for Industry: Dioxin In Anti-Caking Agents Used In Animal Feed And Feed Ingredients | Revised April 12, 2000 | Do | Do |
| Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds—Draft Guidance | June 6, 2000 | Do | Do |
VII. Guidance Documents Issued by the Office of Policy (OP)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How To Obtain A Hard Copy of The Document (Name and Address, Phone, FAX, E-mail, or Internet) |
|---|---|---|---|
| FDA's Development, Issuance, and Use of Guidance Documents | February 27, 1997 | FDA Personnel and Regulated Industry | Internet via www.fda.gov/opacom/morechoices/moreindu.html or Office of Policy (301-827-3360) |
| Draft Guidance for Industry; Exports and Imports under the FDA Export Reform and Enhancement Act of 1996 | June 12, 1998 | Regulated Industry | Internet via www.fda.gov/opacom/fedregister/frexport.html |
| Direct Final Rule Guidance | November 21, 1997 | FDA Personnel | Internet via www.fda.gov/opacom/morechoices/industry/guidedc.htm or Carol Kimbrough (301-827-3480) |
| Industry Supported Scientific and Educational Activities | December 3, 1997 | Regulated Industry | Internet via www.fda.gov/cder/guidance/index.htm or Office of Policy (301-827-3360) |
| Draft Guidance of Broadcast Advertisements | February 1997 | Do | Do |
| Small Entities Compliance Guide On: Regulations to Restrict the Sale and Distribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897) | February 1997 | Do | Internet via www.fda.gov/opacom/campaigns/tobacco/tobret.htm or 1-888-FDA-4KIDS |
| Children & Tobacco—Frequently Asked Questions about the new regulations (DRAFT) | July 1997 | Do | Do |
| Children & Tobacco—A Retailer's Guide to the New Federal Regulations | October 1997 | Do | Do |
| Children & Tobacco—A Guide to the New Federal Regulations | October 1997 | Do | Do |
| FDA's Standards Policy | October 1995 | FDA Personnel and Regulated Industry | 60 FR 53078, October 11, 1995 or Office of Policy (301-827-3360) |
VIII. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)
| Name of Document | Date of Issuance | Grouped by Intended User or Regulatory Activity | How To Obtain A Hard Copy of The Document (Name and Address, Phone, FAX, E-mail, or Internet) |
|---|---|---|---|
| Compliance Policy Guides Manual | August 1996 | FDA Staff Personnel | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-915499) or via Internet www.fda.gov/ora/complianceXref/cpg/cpgtc.html |
| Compliance Policy Guide-DRAFT Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled for Research Use Only or Investigational Use Only | January 5, 1998 | Do | Do—Internet at www.fda.gov/cdrh/comp/ivddrfg.html |
| Compliance Policy Guide 675.400 (CPG 7126.24) REVISION Rendered Animal Feed Ingredients | November 13, 1998 | Do | Do—Internet at www.fda.gov/ora/complianceXref/cpg/cpgvet/cpg675.400.html |
| Compliance Policy Guide DRAFT Distributor Medical Device Reporting | August 28, 1997 | FDA Staff Personnel and Regulated Industry | Do—Internet at www.fda.gov/ora/complianceXref/cpgXmdr3.txt |
| Compliance Policy Guide, Chapter 5, Sec. 555.425, NEW: Foods Adulteration Involving Hard or Sharp Foreign Objects | March 23, 1999 | FDA Staff Personnel | Do—Internet at http://www.fda.gov/ora/complianceXref/cpg/cpgfod/cpg555-425.htm |
| Compliance Policy Guide, Chapter 1, Sec.160.800, NEW:Year 2000 (Y2K) Computer Compliance | April 26, 1999 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/cpg/cpggenl/cpt160.800.html |
| Compliance Policy Guide, Chapter 1, Sec. 140.100, REVISION/DRAFT: Regulatory Policy on the Disposition of Publications That Constitute Labeling (CPG 7153.13) | April 26, 1999 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/cpg/cpgfod/draftrev-cpg715313.htm |
| Compliance Policy Guide, Chapter 1, Sec. 160.850: NEW, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17) | May 13, 1999 | Do | Do—Internet at htpp://www.fda.gov/ora/complianceXref/cpg/cpggenl/cpg160-180.htm |
| Compliance Policy Guide, Chapter 2, Sec. 230.140, NEW, Evaluation and Processing of Post Donation Information Reports | July 9, 1999 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/default.htm |
| Compliance Policy Guide, Chapter 2, Sec. 252.110, NEW: Volume Limits for Automated Collection of Source Plasma | March 6, 2000 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/cpgbio/cpg252.110.htm |
| Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED: Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis | March 22, 2000 | Do | Do—Internet at http://www.fda.gov/ora/cmplianceXref/cpg/cpgbio/cpg257.100.htm |
| Compliance Policy Guide, Chapter 1, Sec. 110.100: REVISED: Certificates for Export | April 14, 2000 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/cpg/cpggenl/cpg110-100.html |
| Medical Device Warning Letter Pilot | March 8, 1999 | FDA Staff Personnel and Regulated Industry | Do—Internet at http://www.fda.gov/ohrms/Dockets/98fr/030899e.pdf |
| Draft Guidance Policy Statement: Draft Civil Money Penalty Reduction Policy for Small Entities | May 18, 1999 | Do | Do—Internet at http://www.fda.gov/ohrms/Dockets/98fr/051899.txt |
| Glossary of Computerized System and Software Development Terminology | August 1995 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127352) or via Internet www.fda.gov/ora/inspectXref/igs/iglist.html |
| Guidelines for Entry Review of Radiation-Emitting Electronic Devices | March 12, 1999 | FDA Staff Personnel | Division of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218 |
| Import Alerts | Continuous | Do | FDA/Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857 or via Internetwww.fda.gov/ora/fiars/oraXimportXalerts.html |
| Investigations Operations Manual | March 2000 | Do | Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 2000 Edition is not yet available on Internet. 1999 Edition is available on Internet at http:// www.fda.gov/ora/inspectXref/iom/iomtc.html |
| Investigations Operations Manual, REVISION: Chapter 4, Sampling | July 1998 | Do | Do |
| Investigations Operations Manual, REVISION: Chapter 5, Establishment Inspections | July 1998 | Do | Do |
| Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related Products | May 15, 2000 | Do | Do—Not available on Internet |
| Laboratory Procedures Manual | June 1994 | Do | Division of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, ATTN: Donna Porter or via Internet www.fda.gov/ora/scienceXref/lpm/lpmtc.html |
| Laboratory Procedures Manual, Chapter X, NEW: Method Validation Samples | May 1999 | Do | Do—Not available on Internet |
| Regulatory Procedures Manual | August 1997 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB97-196182) or via Internet www.fda.gov/ora/complianceXref/rpm/rpmtc.html |
| Regulatory Procedures Manual: UPDATE/New Subchapter/Application Integrity Policy | March 1998 | Do | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet www.fda.gov/ora/complianceXref/rpm/rpmtc.html |
| Regulatory Procedures Manual: UPDATE Subchapter/Warning Letters | March 1998 | Do | Do |
| Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Import Procedures | April 1998 | Do | Do |
| Regulatory Procedures Manual; UPDATE/REVISION Subchapter/Priority Enforcement Strategy for Problem Importers | April 1998 | Do | Do |
| Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Import Procedures | April 1998 | Do | Do |
| Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Notice of Sampling | April 1998 | Do | Do |
| Regulatory Procedures Manual: UPDATE/NEW Subchapter/Granting and Denying Transportation and Exportation (T&E) Entries | May 1998 | Do | Do |
| Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Seizure | June 1998 | Do | Do—Internet at www.fda.gov/ora/complianceXref/rpmXnew2/ch6.html |
| Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Supervisory Charges | June 1998 | Do | Do—Internet at www.fda.gov/ora/complianceXref/rpmXnew2/ch9chgs.html |
| Regulatory Procedures Manual: NEW Subchapter/Civil Penalties—Electronic Product Radiation Control | July 1998 | Do | Do—Internet at www.fda.gov/ora/complianceXref/ch6civpen.html |
| Regulatory Procedures Manual, UPDATE/REVISION: Chapter 4, Subchapter/Warning Letters | March 21, 2000 | Do | Do Internet at http://www.fda.gov/ora/complianceXref/rpmXnew2/ch4.html |
| Guide to Inspections of Bulk Pharmaceutical Chemicals | May 1994 | Do | National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127154) or via Internet www.fda.gov/ora/inspectXref/igs/iglist.html |
| Guide to Inspections of Pharmaceutical Quality Control Laboratories | July 1993 | Do | Do—(NTIS Order No. PB96-127279) |
| Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories | July 1993 | Do | Do—(NTIS Order No. PB96-127287) |
| Guide to Inspections of Validation of Cleaning Processes | July 1993 | Do | Do—(NTIS Order No. PB96-127246) |
| Guide to Inspections of Lyophilization of Parenterals | July 1993 | Do | Do—(NTIS Order No. PB96-127253) |
| Guide to Inspections of High Purity Water Systems | July 1993 | Do | Do—(NTIS Order No. PB96-127261) |
| Guide to Inspections of Dosage Form Drug Manufacturers-CGMPs | October 1993 | Do | Do—(NTIS Order No. PB96-127212) |
| Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation | January 1994 | Do | Do—(NTIS Order No. PB96-127345) |
| Guide to Inspections of Topical Drug Products | July 1994 | Do | Do—(NTIS Order No. PB96-127394) |
| Guide to Inspections of Sterile Drug Substance Manufacturers | July 1994 | Do | Do—(NTIS Order No. PB96-127295) |
| Guide to Inspections of Oral Solutions and Suspensions | August 1994 | Do | Do—(NTIS Order No. PB96-127147) |
| Guide to Inspections of Nutritional Labeling and Education Act (NLEA) Requirements | February 1995 | Do | Do—(NTIS Order No. PB96-127378) |
| Guide to Inspections of Interstate Carriers and Support Facilities | April 1995 | Do | Do—(NTIS Order No. PB96-127386) |
| Guide to Inspections of Dairy Product Manufacturers | April 1995 | Do | Do—(NTIS Order No. PB96-127329) |
| Guide to Inspections of Miscellaneous Foods Vol. I | May 1995 | Do | Do—(NTIS Order No. PB96-127220) |
| Guide to Inspections of Miscellaneous Foods Vol. II | September 1996 | Do | Do—(NTIS Order No. PB97-196133) |
| Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 1-Administrative Procedures/Scheduled Processes | November 1996 | Do | Do—(NTIS Order No. PB97-196141) |
| Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 2- Processes/Procedures | April 1997 | Do | Do—(NTIS Order No. PB97-196158) |
| Guide to Inspections of Cosmetic Product Manufacturers | February 1995 | Do | Do—(NTIS Order No. PB96-127238) |
| Guide to Inspections of Blood Banks | September 1994 | Do | Do—(NTIS Order No. PB96-127303) |
| Guide to Inspections of Source Plasma Establishments | December 1994 | Do | Do—(NTIS Order No. PB96-127360) |
| Guide to Inspections of Infectious Disease Marker Testing Facilities | June 1996 | Do | Do—(NTIS Order No. PB96-199476) |
| Biotechnology Inspections Guide | November 1991 | Do | Do—(NTIS Order No. PB96-127402) |
| Guide to Inspections of Computerized Systems in Drug Processing | February 1983 | Do | Do—(NTIS Order No. PB96-127337) |
| Guide to Inspections of Foreign Medical Device Manufacturers | September 1995 | Do | Do—(NTIS Order No. PB96-127311) |
| Guide to Inspections of Foreign Pharmaceutical Manufacturers | May 1996 | Do | Do—(NTIS Order No. PB96-199468) |
| Mammography Quality Standards Act (MQSA) Auditors Guide | January 1998 | Do | Do—(NTIS Order No. PB98-127178) |
| Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems | December 1997 | Do | Do—(NTIS Order No. PB98-127152) |
| Guide to Inspections of Grain Product Manufacturers | March 1998 | Do | Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 |
| Guide to Bioresearch Monitoring Inspections of In Vitro Devices | February 1998 | Do | Do |
| Guide to Inspections of Viral Clearance Processes for Plasma Derivatives | March 1998 | Do | Do |
| Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations | August 1998 | Do | Do |
| Guide to Inspections of Computerized Systems in the Food Processing Industry | August 1998 | Do | Do—Internet at www.fda.gov/ora/inspectXref/igf/iglist.html |
| Guide to International Inspections and Travel, REVISION (Formerly: FDA/ORA International Inspection Manual and Travel Guide) | July 1999 | Do | Do Revision not available on Internet |
| Guide to Inspections of Quality Systems | August 1999 | Do | Do—Internet at http://www.fda.gov/ora/inspectXref/igs/qsit/QSITGUIDE.PDF |
| Guideline for the Monitoring of Clinical Investigators | January 1988 | FDA Regulated Industry | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 |
| Computerized Systems Used in Clinical Trials | April 1999 | Do | Do—Internet at http://www.fda.gov/ora/complianceXref/bimo/ffinalcct.htm |
| Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research | March 30, 2000 | Do | Do—Internet at http;//www.fda.gov/ora/complianceXref/bimoXerr-guide.htm |
| Compliance Program 7348.808: Bioresearch Monitoring; Good Laboratory Practices (Nonclinical) | Revised August 17, 1998 | FDA Staff Personnel | Do—Internet http://www.fda.gov/ora/complianceXref/bimo/default.html |
| Compliance Program 7348.810: Sponsors, Contract Research Organizations and Monitors | Revised October 30, 1998 | Do | Do |
| Compliance Program 7348.811: Bioresearch Monitoring; Clinical Investigations | Revised September 2, 1998 | Do | Do |
| Food Laboratory Practice Program (Nonclinical Laboratories) 7348.808A; EPA Data Audit Inspections | October 1, 1991 | Do | Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 |
| Compliance Program 7348.809; Bioresearch Monitoring; Institutional Review Board | August 18, 1994 | Do | Do |
| Good Laboratory Practice Regulations Management Briefings | August 1979 | Do | Do—Internet at www.fda.gov/ora/complianceXref/bimo/default.html |
Dated: July 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-18497 Filed 7-20-00; 8:45 am]
BILLING CODE 4160-01-F