title: Cardiovascular Devices; Reclassification of External Cardiac   Compressor; Reclassification of Cardiopulmonary Resuscitation Aids. Final order.
abstract: The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation (CPR) aids, and reclassifying these devices from class III to class II for CPR aids with feedback and to class I for CPR aids without feedback.
mesh_terms: D016887:Cardiopulmonary Resuscitation / Q000145:classification* / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration