According to a study conducted by researchers with the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiologic Health, post-approval studies (PAS) of medical devices fail to include sufficient numbers of female participants. Ellen Pinnow, et al., “Enrollment and  Monitoring of Women in Post-Approval Studies for Medical Devices  Mandated by the Food and Drug Administration,” Journal of Women’s  Health, January 2014.

Noting that FDA “has identified the importance of female participation in medical device trials and adequate representation of populations most likely to use a medical device” and has instituted policies to promote women’s participation, the authors report nonetheless that women’s PAS participation was not systematically tracked until recently. FDA will continue to work with “applicants to develop PAS that enroll and retain proportions of women that are consistent with the sex-specific prevalence for the disease or condition the device is used to treat” and will include sex-specific information when updating medical-device labels with information on health and safety benefits and risks.