510(k) Lag, FDA Cost Accounting Addressed at First MDUFA V Meet

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Industry groups emphasized a “focus on fundamentals,” while FDA eyed “strategic change” as closed-door talks to reauthorize the device user fee program launched last month.

The first closed-door negotiation meeting between industry and FDA to reauthorize device user fees played out as expected. Trade groups emphasized getting down to brass tacks—shoring up missed objectives in the current user fee program and putting a spotlight on exactly how FDA evaluates its resource needs. The agency, meanwhile, seemed to highlight more broadly the opportunity of the next, MDUFA V, user fee program to support the evolution of device oversight in response to advancing technologies and lessons learned from the pandemic.


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