Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration
Ellen Pinnow, MS, Naomi Herz, BS, Nilsa Loyo-Berrios, PhD, and Michelle Tarver, MD, PhD
Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. They may face greater or lesser risk of adverse events or derive more or less benefit. In response, the FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews.