Are enough women included in medical device studies, as required by the FDA?

The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked. A group of authors from the FDA report the results of a study evaluating the participation of women and analysis of sex differences in PAS in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.