FDA Panel Supports Class II Status For Oxygenation Circuit Devices, And Two Other Categories
This article was originally published in The Gray Sheet
The Circulatory System Devices Panel supported class II, with special controls, reclassification proposals from FDA for extracorporeal membrane oxygenators; external cardiac compressors; and external pacemaker pulse generators and triple chamber pacing system analyzers. But the panel had some additional requests for further action by the agency.
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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.
External pacemaker pulse generators and pacing system analyzers would move from class III to class II with special controls in a Sept. 15 proposed order. For most of the products, the 510(k) route would be maintained, but triple-chamber PSAs would move from PMA to 510(k) review under the proposal. .
After much debate, FDA’s Circulatory System Devices panel formed a consensus in support of a class II, special controls designation for extracorporeal circuits for long-term pulmonary and cardiopulmonary support in adults.