# General Hospital and Personal Use Devices: Classification of the Apgar Timer, Lice Removal Kit, and Infusion Stand
> **Food and Drug Administration** · Final rule. · Published 1998-11-05 · Effective 1998-12-07 · 63 FR 59717
## Document
- **Document number:** 98-29568
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 59717
- **CFR reference:** 21 CFR 880
- **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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/11/05/98-29568/general-hospital-and-personal-use-devices-classification-of-the-apgar-timer-lice-removal-kit-and)
---
*AI Analytics · CC0 1.0*