Federal Register #FDA-2026-N-7628

FDA Class II Classification for Non-Medicated Topical Erectile Dysfunction Device

This opportunity involves the FDA's final classification of a non-medicated topical device for erectile dysfunction as a Class II medical device with special controls. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs Mentioned: - Futura Medical Developments Limited (manufacturer of Eroxon device) - Products/Services Requested: - No procurement of products or services is requested; this is a regulatory classification action - Notable Requirements: - Devices must be applied topically to the penis and work by stimulating nerve endings through temperature change - Devices must meet special controls including: - Biocompatibility testing - Non-clinical performance testing (condom compatibility, temperature profile, device specification verification) - Shelf life verification - Specific labeling requirements (condom compatibility, expiration date, non-contraceptive statement, diagnosis information, dosage/frequency of use) - No part numbers, quantities, or procurement actions are included, as this is not a solicitation for goods or services

Description

The Food and Drug Administration (FDA) is classifying the non-medicated topical formulation for treatment of erectile dysfunction into class II (special controls). This classification includes special controls to ensure safety and effectiveness, such as biocompatibility, non-clinical performance testing, shelf life verification, and specific labeling requirements. The action aims to reduce regulatory burdens and enhance patient access to innovative devices. The device is applied on the penis and stimulates nerve endings by inducing a temperature change, leading to tumescence and erection.

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