Evaluation of Sex-Specific Data in Medical Device Clinical Studies

This guide provides recommendations from the Food and Drug Administration regarding the evaluation of sex-specific data in medical device clinical studies. It outlines the FDA's expectations for sex-specific patient enrollment, data analysis, and reporting of study information. The primary aim is to enhance the quality and consistency of data concerning medical device performance across different sexes. The document emphasizes the importance of considering sex and associated covariates during study design, encouraging appropriate enrollment of both sexes in clinical studies. It also details recommended statistical analyses for interpreting sex-specific data and specifies the FDA's expectations for reporting such information in device summaries and labeling. The guidance is intended for devices requiring clinical information for marketing submissions, including premarket notifications and post-approval studies. It serves as a supplement to existing FDA guidance and is not legally enforceable, but rather a set of recommendations for industry adherence.