INFANT RADIANT WARMER DOWNCLASSIFICATION WOULD RELY ON USE OF AAMI STANDARD; FINALIZATION OF STANDARD WILL TAKE AT LEAST A YEAR, AAMI SAYS
This article was originally published in The Gray Sheet
Executive Summary
Infant radiant warmers can be downclassified to Class II devices using a voluntary standard under development by the Association for the Advancement of Medical Instrumentation as a special control, FDA says in a proposed rule published in the Aug. 27 Federal Register.