Gastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant
fda-device · Food and Drug Administration · Rule · Published 2000-02-02 · Effective 2000-03-03 · 65 FR 4881
Document
Document number
00-2148
Federal Register citation
65 FR 4881
CFR reference
21 CFR 876
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.