---
kind: "section"
citation: "21 C.F.R. § 876.3630"
title: "21"
number: "876.3630"
heading: "Penile rigidity implant."
url: "https://uscodex.org/cfr/21/876.3630"
---

# §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.”

## Notes

### Amendments

[65 FR 4882, Feb. 2, 2000]

### 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

[65 FR 4882, Feb. 2, 2000]