Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Evaluation of Sex Differences in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific focus on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this time.