Draft Guidance for Industry and FDA Staff, Availability: Evaluation of Sex Differences in Medical Device Clinical Studies

Link here. Excerpt:

'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.
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The purpose of this guidance is to outline the Center for Devices and Radiological Health's (CDRH's) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and consistency of available data regarding the performance of medical devices in women.'