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

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...