Menstrual tampons and vaginal pessaries: regulation of intravaginal medical devices by the US FDA.

Abstract

Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulato