{"data":{"id":"us/21-cfr-876.5021","jurisdiction":"us","citation":"21 CFR 876.5021","heading":"Non-medicated topical formulation for treatment of erectile dysfunction.","body":"(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.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) The device must be demonstrated to be biocompatible.\n(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:\n(i) Condom compatibility;\n(ii) Temperature profile evaluation; and\n(iii) Verification of device specifications.\n(3) Performance data must support the shelf life of the device by demonstrating the device meets its specifications over the identified shelf life.\n(4) Labeling must include:\n(i) Information regarding compatibility with condoms;\n(ii) An expiration date;\n(iii) A statement that the product is not a contraceptive;\n(iv) Information for the correct diagnosis of erectile dysfunction; and\n(v) Dosage and frequency of use.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart F—Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"0cc10d382891da40f97d502c45e83683d645d47cb2e188f8210fe85f8a0b74bf","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.5020","next":"us/21-cfr-876.5025"},"notice":"GroundRules: Original legal text. Not legal advice."}