# Medical Devices; Reclassification of the Infant Radiant Warmer
> **Food and Drug Administration** · Final rule. · Published 1997-06-19 · Effective 1997-07-21 · 62 FR 33349
## Document
- **Document number:** 97-16123
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 33349
- **CFR reference:** 21 CFR 880
- **Publication date:** 1997-06-19
- **Effective date:** 1997-07-21
- **HHS docket:** Docket No. 85N-0285
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to reclassify the infant radiant warmer from class III (premarket approval) into class II (special controls). The infant radiant warmer is a device intended to maintain the infant's body temperature by means of radiant heat. The special controls are the Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer, a prescription statement, and labeling. This reclassification is based on new information regarding the device contained in a reclassification petition submitted by the Health Industries Manufacturers Association (HIMA). This action is taken under the Medical Device Amendments of 1976 as amended by the Safe Medical Devices Act of 1990.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/06/19/97-16123/medical-devices-reclassification-of-the-infant-radiant-warmer)
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