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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-D-5591]
 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 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies.”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 This draft guidance is not final nor is it for implementation at this time.
 DATES: Submit either electronic or written comments on the draft guidance by April 7, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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)).
                    ( print 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 
                    *CDRH-Guidance@fda.hhs.gov*
                     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 notification
0910-0120814, subparts A through E
Premarket approval
0910-0231814, subpart H
Humanitarian Device Exemption
0910-0332812
Investigational Device Exemption
0910-0078860, subpart D
De Novo classification process
0910-0844“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”
Q-submissions
0910-0756800, 801, and 809
Medical Device Labeling Regulations
0910-0485822
Postmarket Surveillance of Medical Devices
0910-0449( print page 1163)50, 56
Protection of Human Subjects and Institutional Review Boards
0910-0130
 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