Zdrowie i gospodarka · 08/01/2013

FDA Proposes Reclassification of Membrane Lung Devices for Long-Term Pulmonary Support

The FDA is proposing to reclassify membrane lung devices used in long-term pulmonary support procedures, such as extracorporeal membrane oxygenation (ECMO), from a Class III device to a Class II device with special controls, to improve regulatory oversight and patient safety.