In Brief: Infant radiant warmer downclassification
This article was originally published in The Gray Sheet
Infant radiant warmer downclassification: FDA completes 11-year classification effort by moving infant radiant warmers from Class III to Class II in a final rule published in the June 19 Federal Register. The notice finalizes an August 1996 proposed rule to downclassify the devices with special controls ("The Gray Sheet" Sept. 2, p. 11). FDA moved to reclassify the devices after the Health Industry Manufacturers Association submitted a reclassification petition in January 1986 that responded to a proposed rule calling for premarket applications or product development protocols for the devices. Special controls for the device include the Association for the Advancement of Medical Instrumentation Voluntary Standard for the Infant Radiant Warmer, a prescription statement and labeling...
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