Zdrowie i gospodarka · 28.10.2003
Medical Devices; Reclassification of Automated External Defibrillators
The Food and Drug Administration (FDA) announces an opportunity to submit information and comments concerning FDA's intent to initiate a proceeding to reclassify automated external defibrillators (AEDs) from class III (premarket approval) to class II (special controls). AEDs are devices that deliver an electric shock to correct an arrhythmia.