Gastroenterology and Urology Devices; Effective Date of Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device
fda-device · Food and Drug Administration · Rule · Published 2000-09-26 · Effective 2000-10-26 · 65 FR 57726
Document
Document number
00-24632
Federal Register citation
65 FR 57726
CFR reference
21 CFR 876
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-09-26
Effective date
2000-10-26
HHS docket
Docket No. 94N-0380
Abstract
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. 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 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.