Public Citizen's Health Research Group - Comment

Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of ECMO devices 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. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring PMA submissions for these uses.