Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
Key claim: The FDA is classifying external condoms for anal intercourse or vaginal intercourse as Class II medical devices subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external condom for anal intercourse or vaginal intercourse. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Classifying external condoms as Class II with special controls establishes a defined regulatory pathway for manufacturers seeking market entry, replacing case-by-case premarket review with predictable performance standards. For consumers, this preserves FDA oversight of a widely used barrier device for pregnancy and STI prevention while potentially easing the approval process for new products.