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GUIDANCE DOCUMENT

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies Draft Guidance for Industry and Food and Drug Administration Staff January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-5591

Docket Number:
FDA-2023-D-5591
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this draft guidance to provide guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to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. Upon finalization, this document will update the policy reflected in the existing guidance, "Evaluation of Sex-Specific Data in Medical Device Clinical Studies" by addressing both sex- and gender-specific data and will replace the existing guidance.

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