Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Radiation Biodosimetry Medical Countermeasure Devices.” FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.

DATES:

Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2014-D-2065 for “Radiation Biodosimetry Medical Countermeasure Devices.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Radiation Biodosimetry Medical Countermeasure Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5648, Silver Spring, MD 20993-0002, 301-796-5028.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance provides recommendations for the types of information that should be submitted to support marketing authorization (e.g., the clearance or approval) for radiation biodosimetry medical countermeasure devices (referred to as “biodosimetry devices” or “biodosimeters” throughout this document).

This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. Biodosimetry technologies may be used at various stages during triage, including both early mass casualty triage and subsequent clinical evaluation. Such exposures could be the result of intentional harm or as a consequence of a disaster. Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point. Likewise, devices may be designed for use in field triage settings, at patient bedsides, or in Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) certified clinical laboratories. FDA considered both high-throughput and single-use devices in developing this guidance document.

This guidance only applies to validation of diagnostic biodosimetry devices intended to be used to assess radiation absorption that occurs as a result of non-therapeutic or accidental exposures (e.g., a deliberate attack, such as use of an improvised nuclear device, or a natural disaster), and does not apply to medical devices intended to be used to measure doses delivered as a result of radiation therapy nor to devices that measure effects from long-term radiation exposure. In addition, dosimeters, which are devices that detect radiation exposure on a physical substrate rather than through a biological response and are worn by people who might be exposed to radiation during the course of their normal work (such as film badges), are not addressed in this guidance document. Finally, biological assays that might be used to detect the presence of ingested radioisotopes in sputum or urine are not considered in this guidance document.

This guidance document does not provide specific study designs; it describes design principles for studies that may be used to establish a reasonable assurance of the safety and effectiveness of biodosimetry devices.

In the Federal Register of December 30, 2014 (79 FR 78448), the Agency announced the issuance of the draft guidance entitled “Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” In the Federal Register of May 28, 2015 (80 FR 30466), FDA reopened and extended the comment period on the draft guidance. The Agency has considered the comments, as appropriate.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Radiation Biodosimetry Medical Countermeasure Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Radiation Biodosimetry Medical Countermeasure Devices” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400045 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in the guidance document entitled “Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” have been approved under OMB control number 0910-0582; the collections of information in the guidance document entitled “Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization” have been approved under OMB control number 0910-0607; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.