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More Information on the Device Review Process

Letter to FDA on IABP Regulatory Classification

February 13, 2013

View as PDF.

View press release.

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

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