(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.

[91 FR 46834, July 27, 2026]