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FDA lowers regulatory barriers for certain intra-aortic balloons and asks for premarket approval applications and product development protocols for others.

FDA increases regulatory requirements for intra-aortic balloons

The FDA issued a final rule reclassifying certain intra-aortic balloons and demanding more from others, according to a notice in the Federal Register.

The new rule eases regulation on intra-aortic balloons and pumps indicated for acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failure, lowering their classification from Class III to Class II.

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