§876.5021. Non-medicated topical formulation for treatment of erectile dysfunction.
21 C.F.R. § 876.5021
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.
Classification. Class II (special controls). The special controls for this device are:
The device must be demonstrated to be biocompatible.
Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
Condom compatibility;
Temperature profile evaluation; and
Verification of device specifications.
Performance data must support the shelf life of the device by demonstrating the device meets its specifications over the identified shelf life.
Labeling must include:
Information regarding compatibility with condoms;
An expiration date;
A statement that the product is not a contraceptive;
Information for the correct diagnosis of erectile dysfunction; and
Dosage and frequency of use.
Notes, amendments, and revision history
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]