[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1161-1163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5591]
Evaluation of Sex-Specific and Gender-Specific Data in Medical
Device Clinical Studies; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Evaluation of Sex-
Specific and Gender-Specific Data in Medical Device Clinical Studies.''
This document provides guidance on the study and evaluation of sex-
and/or gender-specific data in clinical investigations or research
involving one or more subjects to determine the safety or effectiveness
of a device. The purpose of this guidance is to encourage science-
driven consideration of sex and/or gender, as appropriate for both the
scientific question being addressed and the intended use of the device,
when designing medical device clinical studies and reporting data from
such studies in accordance with legal requirements. This draft guidance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DATES: Submit either electronic or written comments on the draft
guidance by April 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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-2023-D-5591 for ``Evaluation of Sex-Specific and Gender-Specific
Data in Medical Device Clinical Studies.'' 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)).
[[Page 1162]]
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
``Evaluation of Sex-Specific and Gender-Specific Data in Medical Device
Clinical Studies'' 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: Terri Cornelison, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5516, Silver Spring, MD 20993-0002, 301-
796-5682; or James Myers, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Recognition of the importance of sex- and gender-specific
considerations has been steadily growing in areas such as medical
technology design and development, including clinical study design, and
assessing product performance throughout the total product life cycle
and other medical device-related matters. Sex and gender are key
considerations in the development and performance of medical devices.
Although there has been steady growth in the recognition of sex- and
gender-considerations in medical technology design and development, it
is important to understand that this was not always the case.
Historically, females and/or women have been under-represented in or
excluded from many clinical studies. This has led to a lack of
information available for females and/or women and their health care
providers regarding the benefits and risks of many medical devices.
Further, individuals with intersex traits and those with differences in
sex development may have not been properly included within clinical
studies. In addition, historically, as gender was often conflated with
sex or otherwise not properly reported in clinical studies, there is a
lack of data regarding the underrepresentation of nonbinary,
transgender, fluid gender identities and other gender identities.
Given these historical concerns and the growing recognition of the
importance of sex- and gender-specific considerations in medical
technology design and development, it is important that a medical
device be developed and evaluated with study participants that
represent the demographic, clinical, and disease characteristics of the
intended population. The purpose of this draft guidance is to encourage
science-driven consideration of sex and/or gender. Upon finalization,
this document will update the policy reflected in the existing guidance
entitled ``Evaluation of Sex-Specific Data in Medical Device Clinical
Studies'' by addressing both sex- and gender-specific data and will
replace the existing guidance. As such, the recommendations within the
guidance have been updated to help sponsors consider sex- and/or
gender-specific data, as appropriate for the scientific questions being
addressed and the intended use of the device, when designing medical
device clinical studies and reporting data from such studies in
accordance with legal requirements. The guidance provides
recommendations for sponsors to consider sex- and/or gender-specific
data throughout the clinical study process. This includes updated
recommendations for clinical study design, study participant
enrollment, data collection and analysis, and reporting of study
information for sex-specific data, gender-specific data, or both,
according to the scientific question at hand.
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 ``Evaluation
of Sex-Specific and Gender-Specific Data in Medical Device Clinical
Studies.'' 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 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 guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Evaluation of Sex-Specific and Gender-Specific Data in Medical Device
Clinical Studies'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001727 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:
------------------------------------------------------------------------
21 CFR Part or guidance Topic OMB control No.
------------------------------------------------------------------------
807, subpart E............... Premarket 0910-0120
notification.
814, subparts A through E.... Premarket 0910-0231
approval.
814, subpart H............... Humanitarian 0910-0332
Device
Exemption.
812.......................... Investigational 0910-0078
Device
Exemption.
860, subpart D............... De Novo 0910-0844
classification
process.
``Requests for Feedback on Q-submissions... 0910-0756
Medical Device Submissions:
The Pre-Submission Program
and Meetings with Food and
Drug Administration Staff''.
800, 801, and 809............ Medical Device 0910-0485
Labeling
Regulations.
822.......................... Postmarket 0910-0449
Surveillance of
Medical Devices.
[[Page 1163]]
50, 56....................... Protection of 0910-0130
Human Subjects
and
Institutional
Review Boards.
------------------------------------------------------------------------
Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31526 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P