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FDA Panel Supports Class II Status For Oxygenation Circuit Devices, And Two Other Categories

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.

FDA’s Circulatory System Devices Panel met this month and generally assented to FDA’s proposals to designate as class II and establish special controls for three device categories: extracorporeal membrane oxygenators; external pacemaker pulse generators and triple chamber pacing system analyzers; and external cardiac compressors. But while the panel agreed with FDA’s top-line proposals, it had some additional requests of the agency for further action in each area.

The product types are among the last remaining preamendment devices that have yet to be formally classified by FDA. In the meantime, they remain designated as class III products, but can enter the market via 510(k) clearance

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