[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75635-75637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4599]


Content of Human Factors Information in Medical Device Marketing 
Submissions; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Content of Human 
Factors Information in Medical Device Marketing Submissions.'' This 
draft guidance provides a risk-based framework to guide manufacturers 
and FDA staff on the human factors information that should be included 
in a marketing submission to the Center for Devices and Radiological 
Health to facilitate the efficiency of the FDA review process. This 
draft guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 9, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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

[[Page 75636]]

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2015-D-4599 for ``Content of Human Factors Information in Medical 
Device Marketing Submissions.'' 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 Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 draft guidance document entitled 
``Content of Human Factors Information in Medical Device Marketing 
Submissions'' to the Office of Policy, 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: Tania Reina, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2502, Silver Spring, MD 20993-0002, 301-221-7499.

SUPPLEMENTARY INFORMATION:

I. Background

    A unique aspect of medical devices is the critical role of device-
user interface interactions for their safe use. Manufacturers routinely 
perform human factors assessments of the human-device interface during 
device development. This draft guidance provides a risk-based framework 
to guide manufacturers and FDA staff on the human factors information 
that should be included in a marketing submission to the Center for 
Devices and Radiological Health (CDRH) to facilitate the efficiency of 
the FDA review process.
    On February 3, 2016, FDA announced in the Federal Register a draft 
guidance entitled ``List of Highest Priority Devices for Human Factors 
Review'' (81 FR 5756). FDA is issuing a revised draft guidance, now 
entitled ``Content of Human Factors Information in Medical Device 
Marketing Submissions,'' after considering stakeholder feedback on the 
draft guidance that issued February 3, 2016. This draft guidance 
provides FDA's risk-based policy regarding submission of human factors 
information for the purposes of premarket review in response to 
stakeholder feedback.
    When finalized, this draft guidance is intended to be used to 
complement the FDA guidance ``Applying Human Factors and Usability 
Engineering to Medical Devices'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) (hereafter referred to as the 
Human Factors Guidance). After reviewing public comment on this draft 
guidance and upon its finalization, FDA intends to concurrently revise 
the Human Factors Guidance to incorporate the definitions included in 
this guidance, superseding the definitions in section 3 of the Human 
Factors Guidance. FDA also intends to concurrently revise the Human 
Factors Guidance by replacing Section 9 ``Documentation'' and Appendix 
A ``Human Factors and Usability Engineering Report'' of the Human 
Factors Guidance with cross-references to section V of this guidance, 
and by making any other revisions to the Human Factors Guidance as 
appropriate.
    FDA recognizes and anticipates that the Agency and industry may 
need up to 60 days to perform activities to operationalize the policies 
within this guidance. If new information regarding the content of human 
factors information for marketing submissions is not included in a 
marketing submission received by FDA before or up to 60 days after the 
publication of the final guidance, CDRH staff does not generally intend 
to request such information during the review of the submission. CDRH 
does, however, intend to review any such information, if submitted.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (21 CFR 10.115). The draft guidance, when finalized, 
will represent the current thinking of FDA on the topic thereof. 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.

[[Page 75637]]

II. Electronic Access

    Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document 
is also available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Content of Human Factors Information 
in Medical Device Marketing Submissions'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1500052 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
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    Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26767 Filed 12-8-22; 8:45 am]
BILLING CODE 4164-01-P