Medical Devices; Reclassification of the Infant Radiant Warmer
fda-device · Food and Drug Administration · Rule · Published 1997-06-19 · Effective 1997-07-21 · 62 FR 33349
Document
Document number
97-16123
Federal Register citation
62 FR 33349
CFR reference
21 CFR 880
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.