FDA Classifies Non-Medicated ED Cream: Special Controls Apply
Published Date: 7/27/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Class II Classification Eases Access
FDA has classified the non‑medicated topical formulation for treatment of erectile dysfunction as Class II (special controls). FDA says this Class II classification will provide reasonable assurance of safety and effectiveness and will enhance patients' access by reducing regulatory burdens; the order is effective July 27, 2026 and the classification was applicable June 9, 2023.
Creates Predicate for Future Devices
Because FDA classified this device via the De Novo process, the device can serve as a predicate for future devices of the same type. That means other sponsors may use the less burdensome 510(k) process instead of submitting a new De Novo request or a premarket approval application.
510(k) Premarket Notification Required
FDA states that non‑medicated topical formulations for erectile dysfunction are subject to premarket notification under section 510(k). At this time, FDA has not exempted this device type from 510(k) requirements, so sponsors must submit a 510(k) to market these Class II devices.
Required Testing and Labeling Controls
The rule lists special controls manufacturers must meet: demonstrate biocompatibility; non‑clinical performance testing including (i) condom compatibility, (ii) temperature profile evaluation, and (iii) verification of device specifications; shelf life performance data; and labeling that includes condom compatibility, an expiration date, a statement that the product is not a contraceptive, information for correct diagnosis of erectile dysfunction, and dosage and frequency of use.
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