INFANT RADIANT WARMER CLASS II STATUS WITH SPECIAL CONTROLS RECOMMENDED
This article was originally published in The Gray Sheet
Executive Summary
INFANT RADIANT WARMER CLASS II STATUS WITH SPECIAL CONTROLS RECOMMENDED unanimously by FDA's General Hospital and Personal Use Devices Panel at a May 11 meeting. The group voted 4-0 to recommend downclassification of the pro-amendment Class III device and use of the Association for the Advancement of Medical Instrumentation draft infant radiant warmer voluntary standard as a special control.
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