General Hospital and Personal Use Devices: Classification of the Apgar Timer, Lice Removal Kit, and Infusion Stand
fda-device · Food and Drug Administration · Rule · Published 1998-11-05 · Effective 1998-12-07 · 63 FR 59717
Document
Document number
98-29568
Federal Register citation
63 FR 59717
CFR reference
21 CFR 880
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-11-05
Effective date
1998-12-07
HHS docket
Docket No. 98N-0087
Abstract
The Food and Drug Administration (FDA) is classifying the Apgar timer, the lice removal kit, and the infusion stand into class I (general controls) based on new information regarding these devices. FDA is also exempting the devices from the requirement of premarket notification and is exempting the Apgar timer from most of the requirements of the good manufacturing practice regulations. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).