Zdrowie i gospodarka · 25/05/2016

FDA Reclassifies External Cardiac Compressors and Cardiopulmonary Resuscitation Aids

The US Food and Drug Administration (FDA) has issued a final order to reclassify external cardiac compressors, previously classified as a Class III device, into a Class II category with special controls. The FDA is also reclassifying a subgroup of devices, previously classified as Class III, into Class II for devices with feedback and Class I for devices without feedback, under a new classification regulation for cardiopulmonary resuscitation (CPR) aids.