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.
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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.
The rule was set to go into effect 15 March, but the government is delaying it for at least two months to discuss the resources needed for the payments – and whether they’re the right policy to start with.
The Medicare rule, which was delayed by 60 days under a broader regulatory freeze, is seen as critical to the reimbursement of innovative devices.