Medical Devices; Exemptions From Premarket Notification; Class II Devices
fda-device · Food and Drug Administration · Rule · Published 1999-03-29 · Effective 1999-03-29 · 64 FR 14830
Document
Document number
99-7746
Federal Register citation
64 FR 14830
CFR reference
21 CFR 874
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1999-03-29
Effective date
1999-03-29
HHS docket
Docket No. 98P-0833
Abstract
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for audiometers with certain limitations. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).