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.
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The head of the US agency’s device center tells Medtech Insight that while he’s proud of his staff for taking on the extra workload due to the pandemic, product review times are slowing because resources are stretched thin.
Exclusive: Top Medical Device Lobbyist On User-Fee Talks, Biden And New Congress, Implementing MCIT Rule
The MDMA’s Mark Leahey talked with Medtech Insight about how the medical device industry responded to the COVID-19 pandemic, plans for working with a new administration and Congress, and hopes for the MDUFA negotiations.
The US FDA and industry stakeholders are set to finally start monthly user fee negotiations online by February. The process has already been significantly delayed due to the pandemic and recent holidays.