Cardiovascular, orthopedic, and physical medicine diagnostic devices; reclassification of cardiopulmonary bypass accessory equipment, goniometer device, and electrode cable devices. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.
D002315:Cardiopulmonary Bypass / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004566:Electrodes; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification; D006801:Humans; D007596:Joints / Q000502:physiology; D016059:Range of Motion, Articular; D014481:United States; D014486:United States Food and Drug Administration