# Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant
> **Food and Drug Administration** · Final rule. · Published 2000-02-02 · Effective 2000-03-03 · 65 FR 4881
## Document
- **Document number:** 00-2148
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 4881
- **CFR reference:** 21 CFR 876
- **Publication date:** 2000-02-02
- **Effective date:** 2000-03-03
- **HHS docket:** Docket No. 97N-0481
## Abstract

The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/02/02/00-2148/gastroenterology-urology-devices-reclassification-of-the-penile-rigidity-implant)
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