21 CFR § 876.3630 - Penile rigidity implant.

---
identifier: "/us/cfr/t21/s876.3630"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.3630 - Penile rigidity implant."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.3630"
section_name: "Penile rigidity implant."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.3630 Penile rigidity implant.

(a) *Identification.* A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

(b) *Classification.* Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

[65 FR 4882, Feb. 2, 2000]