Letter to FDA on IABP Regulatory Classification
February 13, 2013
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Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposal to reclassify the intra-aortic balloon pump pre-amendment Class III device to Class II (special controls) for three common indications and to publish a notice immediately that proposes a final regulation requiring the device to remain in Class III for all indications, and require pre-market approval applications for new intra-aortic balloon pumps.
February 28, 2013, Response letter from FDA