Federal Register #2026-15074

FDA Classifies Non-Medicated Topical Formulation for Erectile Dysfunction as Class II Device

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final order regarding the classification of non-medicated topical formulations for erectile dysfunction. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Device Classification: - Non-medicated topical formulations for erectile dysfunction are now classified as class II medical devices with special controls - Devices are applied to the penis and stimulate nerve endings by inducing a temperature change, resulting in tumescence and erection - Regulatory Requirements: - Subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act - Special controls include: - Biocompatibility testing - Non-clinical performance testing (e.g., condom compatibility, temperature profile evaluation) - Shelf life validation - Specific labeling requirements - No specific OEMs, vendors, products, part numbers, or purchase quantities are identified in this notice - The order establishes the regulatory pathway for manufacturers seeking to market these devices

Description

The Food and Drug Administration (FDA) is classifying the non-medicated topical formulation for treatment of erectile dysfunction into class II with special controls. This device is applied on the penis and stimulates nerve endings by inducing a temperature change, leading to tumescence and erection. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The order is effective July 27, 2026, and the classification was applicable on June 9, 2023. The device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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