[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39272-39274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14200]


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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Product Availability, Compliance, and Enforcement Decisions; Draft 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Factors to Consider 
Regarding Benefit-Risk in Medical Device Product Availability, 
Compliance, and Enforcement Decisions.'' This draft guidance, when 
finalized, 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 consideration of the factors listed in 
the draft guidance, when relevant, will improve the consistency and 
transparency of those decisions and that a shared understanding of 
benefit and risk will 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 This draft guidance is not final 
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 14, 2016.

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

[[Page 39273]]

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 draft 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 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.

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 draft guidance, when finalized, is intended to provide a shared 
benefit-risk framework for FDA and stakeholders and to set forth 
overarching principles. FDA may consider the types of benefit-risk 
factors described in the draft guidance--including reliable patient 
preference information from a representative sample--on a case-by-case 
basis when determining the appropriate regulatory action 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 types of decisions.
    In addition, the draft guidance, when finalized, 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 (IDE) applications. The benefit-
risk factors in the draft guidance also support evaluation of medical 
devices with real world evidence.
    The principles described in the draft 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 evaluate the 
benefit-risk factors during, for example, assessments 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 (PMA) preapproval inspection. 
Premarket review decisions, such as premarket notification (510(k)) 
substantial equivalence determinations, de novo classification, and 
PMA, humanitarian device exemption (HDE) or IDE application approval 
decisions, are beyond the scope of this draft guidance.
    The draft guidance applies to both diagnostic and therapeutic 
medical devices subject to, and exempt from, premarket review. The 
scope of the draft guidance excludes medical devices regulated by FDA's 
Center for Biologics Evaluation and Research (CBER); 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) as 
regulated by CDRH under the Electronic Product Radiation Control (ERPC) 
provisions in the FD&C Act and implementing regulations (21 CFR 
Subchapter J--Radiological Health). This draft guidance does not apply 
to products (e.g., drugs, biologics, dietary supplements, foods, 
tobacco products, or cosmetics) regulated by other FDA Centers.

II. Significant of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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 http://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 draft guidance refers to previously approved collections of 
information found in FDA regulations.

[[Page 39274]]

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: June 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14200 Filed 6-15-16; 8:45 am]
 BILLING CODE 4164-01-P