Medical Devices; Exemptions From Premarket Notification; Class II Devices
fda-device · Food and Drug Administration · Rule · Published 1999-01-08 · Effective 1999-01-08 · 64 FR 1123
Document
Document number
99-380
Federal Register citation
64 FR 1123
CFR reference
21 CFR 862
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-01-08
Effective date
1999-01-08
HHS docket
Docket Nos. 98P-0506 and 98P-0621
Abstract
The Food and Drug Administration (FDA) is publishing an order granting petitions requesting exemption from the premarket notification requirements for certain class II devices. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).