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[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]

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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Device Clinical Studies; Draft Guidance for Industry and Food and Drug 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.

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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the availability of the draft guidance entitled ``Evaluation of Sex-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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by April 7, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.
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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.
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    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
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