Public Citizen Again Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices
Public Citizen testified before the FDA’s Circulatory System Devices Panel reiterating its opposition to the reclassification of ECMO devices from Class III to Class II for two pediatric indications and opposing a potential further Class II reclassification for acute catastrophic cardiogenic shock in adult patients. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.