Zdrowie i gospodarka · 12/02/2016

FDA Redesignates Anesthesiology Devices for Long-Term Pulmonary Support

The FDA is reclassifying membrane lung devices for long-term pulmonary support from Class III to Class II, with special controls, for patients with acute respiratory or cardiopulmonary failure, and is redesignating them as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.