Topical gels for erectile dysfunction now have a permanent home in federal device regulation, and with it a fixed list of tests a manufacturer must pass before selling one in the United States.
The Food and Drug Administration published a final order placing the "non-medicated topical formulation for treatment of erectile dysfunction" into class II with special controls, effective July 27. The order adds a new section, 21 CFR 876.5021, to the code that governs gastroenterology and urology devices.
