Comments on Reauthorization of the Medical Device User Fee Amendments, FY 2028-2032

FDA should convert at least one outcome measure for its Total Product Life Cycle Advisory Program (TAP) into a formal, annually reported performance commitment as the program expands across all device areas, and should establish new commitments on the quality of predicate selection and substantial equivalence determinations in 510(k) review. The agency should also coordinate with CMS so that class II devices qualify for expedited coverage pathways such as RAPID only when clearance rested on clinical evidence in populations representative of Medicare beneficiaries, and should require that AI-enabled devices citing only non-AI predicates demonstrate safety and effectiveness through device-specific performance data.