[Federal Register Volume 91, Number 103 (Friday, May 29, 2026)]
[Notices]
[Pages 32061-32062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-10734]
[[Page 32061]]
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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; 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 a final guidance titled ``Content of Human Factors
Information in Medical Device Marketing Submissions.'' This 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.
DATES: The announcement of the guidance is published in the Federal
Register on May 29, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 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 guidance document titled
``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. 5441, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
An important consideration for medical devices is the critical
impact the device user interface design has on the safe and effective
use of the device. Manufacturers routinely perform human factors
assessments of the device user interface during device development. The
purpose of this guidance is to provide a risk-based framework to guide
manufacturers and FDA staff on the human factors information that
should be included in a marketing submission to CDRH to facilitate the
efficiency of the FDA review process.
On February 3, 2016, FDA announced in the Federal Register a draft
guidance titled ``List of Highest Priority Devices for Human Factors
Review'' (81 FR 5756). FDA issued a revised draft guidance on December
9, 2022, titled ``Content of Human Factors Information in Medical
Device Marketing Submissions,'' after considering stakeholder feedback
on the draft guidance that issued February 3, 2016. Accordingly, the
``Content of Human Factors Information in Medical Device Marketing
Submissions'' draft guidance replaced the ``List of Highest Priority
Devices for Human Factors Review'' draft guidance. The revised draft
guidance provided FDA's risk-based draft policy regarding submission of
human factors information for the
[[Page 32062]]
purposes of premarket review in response to stakeholder feedback.
This final 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).
FDA recognizes and anticipates that the Agency and industry may
need a minimum of 60 days to perform activities to operationalize the
policies within this guidance. For regulatory submissions that are
currently pending with FDA after publication of the guidance, as well
as those submissions received before August 1, 2026, FDA generally does
not anticipate that manufacturers will be ready to include the newly
recommended information outlined in the guidance in their submission.
FDA, however, intends to review any such information if submitted at
any time.
A notice of availability of the draft guidance appeared in the
Federal Register of December 9, 2022 (87 FR 75635). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including additional risk-based factors to consider
when determining the Human Factors Submission Category, new
illustrative examples and Appendices, and clarifications to the scope
of the 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 Content of Human Factors Information in
Medical Device Marketing Submissions. 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.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all CDRH 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 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 GUI01500052 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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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 Use 0910-0332
Devices; Humanitarian
Device Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality
Management System
Regulation (QMSR).
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10734 Filed 5-28-26; 8:45 am]
BILLING CODE 4164-01-P