FDA Classifies Condoms for Anal or Vaginal Use as Class II Medical Devices

The Food and Drug Administration has officially placed external condoms designed for anal or vaginal intercourse into Class II of its medical device classification system. This final order responds to a request from Global Protection Corp. to formally define how these devices will be regulated going forward.

Why it matters: This action is primarily regulatory housekeeping that clarifies the pathway for manufacturers to bring these specific condoms to market. By moving the device out of the automatic Class III category, the FDA removes a heavier regulatory hurdle and allows future competitors to use a standard premarket notification process instead of a full premarket approval. The practical effect is a clearer compliance route for makers and a formalized safety checklist for regulators.

Who it affects

• Manufacturers and importers of external condoms designed for anal or vaginal use

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This final order was issued by the Food and Drug Administration and published in the Federal Register; readers relying on the regulatory details should review the original document and the codified rule at 21 CFR 884.5305.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document