MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments

The most recent Medical Device User Fee Amendments meeting minutes expose how the US agency and the medtech industry continue to disagree over the agency’s previous user-fee commitments and desire to get more funding.

Uncle sam and another person struggling over a money bag

The US Food and Drug Administration and medtech industry representatives have significant disagreements over whether the agency has met its previous user-fee obligations and if it needs more funding to continue improving its premarket review process.

The Medical Device User Fee Amendments V (MDUFA V) negotiations between the FDA and industry groups is finally underway after almost a yearlong delay because of the COVID-19 pandemic. Agency...

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