Notice2022-26767
Content of Human Factors Information in Medical Device Marketing Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
December 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Content of Human Factors Information in Medical Device Marketing Submissions." This draft guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the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 This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 87 Issue 236 (Friday, December 9, 2022)</title>
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[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Notices]
[Pages 75635-75637]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Submissions; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Content of Human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draft guidance provides a risk-based framework to guide manufacturers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draft guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 9, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices</a>) (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.
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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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This draft guidance document
is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Content of Human Factors Information
in Medical Device Marketing Submissions'' may send an email request to
<a href="/cdn-cgi/l/email-protection#f6b5b2a4bedbb1839f9297989593b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="2e6d6a7c6603695b474a4f404d4b6e484a4f0046465d00494158">[email protected]</span></a> 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
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