Zdrowie i gospodarka · 11/04/2000

FDA Reclassifies Cardiopulmonary Bypass Accessory Equipment, Goniometer Device, and Electrode Cable Devices

The US Food and Drug Administration (FDA) is reclassifying cardiopulmonary bypass accessory equipment, goniometer devices, and electrode cable devices from Class I to Class II, exempting them from premarket notification requirements, in an effort to establish sufficient regulatory controls for patient safety and effectiveness.