[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95143-95145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1495]


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.

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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'').

[[Page 95144]]

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

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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 
[email protected] 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.

    Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31145 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P