---
kind: "section"
citation: "21 C.F.R. § 876.5021"
title: "21"
number: "876.5021"
heading: "Non-medicated topical formulation for treatment of erectile dysfunction."
url: "https://uscodex.org/cfr/21/876.5021"
---

# §876.5021. Non-medicated topical formulation for treatment of erectile dysfunction.

- (a) **Identification.** A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The device must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Condom compatibility;
    - (ii) Temperature profile evaluation; and
    - (iii) **Verification of device specifications.**
  - (3) Performance data must support the shelf life of the device by demonstrating the device meets its specifications over the identified shelf life.
  - (4) Labeling must include:
    - (i) Information regarding compatibility with condoms;
    - (ii) An expiration date;
    - (iii) A statement that the product is not a contraceptive;
    - (iv) Information for the correct diagnosis of erectile dysfunction; and
    - (v) **Dosage and frequency of use.**

## Notes

### Amendments

[91 FR 46834, July 27, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[91 FR 46834, July 27, 2026]