Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: New condom classification streamlines access and safety, (May 12, 2026)

By WK Editorial Staff

The FDA issued a final order classifying external condoms for anal or vaginal intercourse as class II medical devices with special controls, determining this approach ensures safety and effectiveness while reducing regulatory burden and improving access to innovative products.

The FDA issued a final order classifying external condoms for anal or vaginal intercourse as class II medical devices subject to special controls designed to ensure safety and effectiveness. The classification, made through the De Novo process, reflects the agency’s determination that general and special controls together are sufficient to mitigate risks such as infection, pregnancy, device failure, and improper use. By moving the device from its default class III status, the FDA aims to reduce regulatory burdens and improve patient access to innovative products. The rule also codifies specific performance, testing, and labeling requirements manufacturers must meet. The order took effect May 8, 2026, and formally establishes the device classification in FDA regulations (Final Rule, 91 Fed. Reg. 25109 (May 8, 2026)).

Dates. This order is effective May 8, 2026. The classification was applicable on February 23, 2022.

FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews