Gastroenterology and Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device; Correction
fda-device · Food and Drug Administration · Rule · Published 2000-10-30 · 65 FR 64619
Document
Document number
00-27736
Federal Register citation
65 FR 64619
CFR reference
21 CFR 876
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-10-30
HHS docket
Docket No. 94N-0380
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of September 26, 2000 (65 FR 57726). The final rule requires the filing of a premarket approval application or a notice of completion of a product development protocol for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. In the final rule, the effective date was stated incorrectly. This document corrects that error.