# 2026-15074: FDA Classifies Non-Medicated ED Cream: Special Controls Apply

2026-15074, Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-07-27, effective 2026-07-27; PRIA reads it as touching household money (as of 2026-08-03).

- Canonical: https://policyrisk.com/federal-register/2026-15074
- As of: 2026-08-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15074
- Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 46833
- Published: 2026-07-27
- Effective: 2026-07-27
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-03

## In one line

FDA Classifies Non-Medicated ED Cream: Special Controls Apply

## 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.

## Effects PRIA read

- Class II Classification Eases Access: benefit, medium. 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 or…
- Creates Predicate for Future Devices: benefit, medium. 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: cost, medium. 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: benefit, medium. 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 c…

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## Sources
- [2026-15074 on federalregister.gov](https://www.federalregister.gov/documents/2026/07/27/2026-15074/medical-devices-gastroenterology-urology-devices-classification-of-the-non-medicated-topical)
- [2026-15074 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-07-27/pdf/2026-15074.pdf)

## Related
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Source: PRIA, https://policyrisk.com/federal-register/2026-15074 (as of 2026-08-03).