Evaluation of Sex Differences in Medical Device Clinical Studies DRAFT GUIDANCE

The purpose of this guidance is to outline the Center for Devices and Radiological Health’s (CDRH) 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 both sexes by ensuring appropriate representation by sex in clinical studies of devices, and that data from such studies is appropriately analyzed for sex differences. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others. The specific objectives of this guidance are: 1) to provide recommendations for study design and conduct to encourage enrollment of women in proportions that are representative of the demographics of disease distribution; 2) to outline recommended statistical analyses of study data for sex differences, and to identify sex-specific questions for further study; 3) to encourage the consideration of sex and associated covariates (e.g., body size, plaque morphology, etc.) during the study design stage; and 4) to specify CDRH’s expectations for reporting sex-specific information in summaries and labeling for approved devices.