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Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies. The draft guidance encourages science-driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the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 2014 guidance Evaluation of Sex-Specific Data in Medical Device Clinical Studies.
Note: This draft guidance is not for implementation at this time. The FDA will consider comments on this draft guidance before it begins work on the final version of the guidance.
Submit comments on this draft guidance
Submit comments under docket number FDA-2023-D-5591 at www.regulations.gov by April 7, 2025, to ensure the FDA considers comments on this draft guidance before it begins work on the final version.
Questions?
If you have questions about this draft guidance, contact CDRHHealthofWomen@fda.hhs.gov.
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