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MedTech industry expresses concerns over FDA’s TAP 2.0 program

02 - March - 2026

The medical device industry has expressed concerns about the US Food and Drug Administration’s revised proposals for resource allocations and enrollment for the Total Product Lifecycle (TAP) program 2.0 program as part of the negotiations for the Medical Device User Fee Amendments VI (MDUFA). Industry also supported extending benefits beyond enrolled products.

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