Oxygenation Circuit Devices Find A Class II Home With FDA

The agency issued a final order reclassifying and renaming membrane lung devices to acknowledge their role as one component of a larger extracorporeal membrane oxygenation (ECMO) system. The decision follows 2013 and 2014 advisory panel recommendations.

A Feb. 12 FDA final order

granted class II status to membrane lung devices, and also expanded and renamed the device category as “extracorporeal circuit and...

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