FDA Classifies Non-Medicated Erectile Dysfunction Topical Device As Class II
July 26, 2026
July 26, 2026
WASHINGTON, July 26 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a non-medicated topical formulation for treatment of erectile dysfunction as a Class II medical device subject to special controls, establishing requirements intended to provide reasonable assurance of safety and effectiveness.
The order, effective July 27, 2026, codifies a classification that FDA applied June 9, 2023, following a De Novo request from Futura Me . . .
The order, effective July 27, 2026, codifies a classification that FDA applied June 9, 2023, following a De Novo request from Futura Me . . .