Public Citizen Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices
September 12, 2013
View as PDF.
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of ECMO devices from Class III to Class II for conditions in which imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery in pediatric 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.