Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; 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 “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” This guidance is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Although product availability and other medical device compliance and enforcement decisions are generally fact-specific, FDA believes that explaining how we consider the factors listed in the guidance will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry's and FDA's focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients. This guidance is in effect at this time.

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: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2016-D-1495 for the guidance entitled “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://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 https://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 https://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 “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions” 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:

Ann M. Ferriter, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3680, Silver Spring, MD 20993, 301-796-5530.

SUPPLEMENTARY INFORMATION:

I. Background

The guidance is intended to provide a framework for FDA and stakeholders that sets forth overarching benefit-risk principles. FDA may consider the types of benefit-risk factors described in the guidance—including reliable patient input from a representative sample—on a case-by-case basis when determining the appropriate regulatory actions to take and to help ensure that informed and science-based decisions are made to the greatest extent practicable. Factors may be weighted differently for different decisions and as the timeframe allows. FDA intends to use pilots and other evaluation techniques to help determine how to apply the benefit-risk framework described in this guidance. Because of the variability in the facts of, and data available for, each decision, specific factors that will inform FDA's thinking may vary.

In addition, the guidance is intended to harmonize FDA's approach to weighing benefits and risks for medical device product availability, compliance, and enforcement decisions with FDA's benefit-risk framework for evaluating medical device marketing and investigational device exemption applications. The benefit-risk factors in the guidance also support assessment of medical devices with real world evidence.

The framework described in the guidance may be applicable to industry and FDA decisions. The benefit-risk factors may be considered when device manufacturers evaluate appropriate responses to nonconforming product or regulatory compliance issues, such as determining whether to limit the availability of a medical device (e.g., a voluntary recall or market withdrawal). FDA may consider the benefit-risk factors during, for example, the evaluation of device shortage situations, selection of the appropriate regulatory engagement mechanism following an inspection during which regulatory non-compliance was observed, evaluation of recalls and consideration of petitions for variance from those sections of the Quality System regulation (21 CFR part 820) for which there were inspectional observations during a premarket approval preapproval inspection.

The guidance applies to both diagnostic and therapeutic medical devices subject to, and exempt from, premarket review. The scope of the guidance excludes medical devices regulated by FDA's Center for Biologics Evaluation and Research combination products, as defined in 21 CFR 3.2(e), for which the Center for Devices and Radiological Health (CDRH) is not the lead Center; and electronic products that are not devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)) as regulated by CDRH under the Electronic Product Radiation Control provisions in the FD&C Act and implementing regulations (21 CFR Subchapter J—Radiological Health). This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, tobacco products, or cosmetics) regulated by other FDA Centers.

In the Federal Register of June 16, 2016 (81 FR 39272), FDA published a notice of availability for the draft guidance entitled “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” FDA considered the comments received on the draft guidance and has revised the guidance as appropriate in response to the comments.

II. Significant 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 “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” 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 using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500065 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 7, subpart C, have been approved under OMB control number 0910-0249. The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485. The collections of information in 21 CFR part 803, regarding medical device reporting, have been approved under OMB control numbers 0910-0291, 0910-0437, and 0910-0471. The collections of information in 21 CFR part 806 have been approved under OMB control number 0910-0359. 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 810, regarding medical device recall authority, have been approved under OMB control number 0910-0432. 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, subparts B and E, have been approved under OMB control number 0910-0231. The collections of information in 21 CFR part 820, regarding the Quality System regulation, have been approved under OMB control number 0910-0073. The collections of information in 21 CFR part 822, regarding postmarket surveillance of medical devices, have been approved under OMB control number 0910-0449.