FDA GUIDANCE · FINALMarch 31, 2025

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

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Premarket, Good Clinical Practice (GCP)

Issue date

March 31, 2025

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