FDA panel: 30-year-old ECMO therapy should be reclassified to lower-risk Class II

September 13, 2013 by Ingrid Mezo

An FDA advisory panel recommends reclassifying extracorporeal membrane oxygenator therapy from the highest-risk category to the less-risky Class II designation.

FDA panel: 30-year-old ECMO therapy should be reclassified to lower-risk Class II

An FDA panel yesterday recommended that the FDA reclassify membrane lung for long-term pulmonary support systems, or so-called extracorporeal membrane oxygenator circuits and accessories, from the highest-risk Class III category to the less burdensome Class II, with special controls.

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