AED downclassification?
This article was originally published in The Gray Sheet
Executive Summary
FDA may ask its Circulatory System Devices Panel to discuss the downclassification of automatic external defibrillators to Class II, the agency announces in the Oct. 28 Federal Register. The agency urges stakeholders to submit new safety and efficacy data on AEDs, currently designated Class III devices. A final rule downclassifying arrhythmia detectors and alarms to Class II with special controls, along with an accompanying guidance, also was issued Oct. 28. FDA announced its plans to reclassify arrhythmia detectors and alarms in December 2002, responding to petitions from AdvaMed, Quinton Instrument and Zymed Medical Instrumentation (1"The Gray Sheet" Dec. 23, 2002, p. 24)...