Medical Devices; Exemptions From Premarket Notification; Class II Devices; Vascular Tunnelers
fda-device · Food and Drug Administration · Rule · Published 2000-03-03 · Effective 2000-03-03 · 65 FR 11466
Document
Document number
00-5159
Federal Register citation
65 FR 11466
CFR reference
21 CFR 870
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2000-03-03
Effective date
2000-03-03
HHS docket
Docket No. 99P-4064
Abstract
The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).