Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down. Medtech Insight articles addressing topics discussed in this episode: FDA Official: Uptick In PMA, 510(k) Applications Calls For More User Fee Dollars https://medtech.pharmaintelligence.informa.com/MT144795/FDA-Official-Uptick-In-PMA-510k-Applications-Calls-For-More-User-Fee-Dollars MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance https://medtech.pharmaintelligence.informa.com/MT144544/MDUFA-IV-Report-US-FDA-Needs-To-Publish-Digital-Health-Guidance US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’ https://medtech.pharmaintelligence.informa.com/MT144512/US-FDAs-Shuren-Promises-MDUFA-Update-Relatively-Soon MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds https://medtech.pharmaintelligence.informa.com/MT144183/MDUFA-V-Industry-FDA-Tangle-Over-TAP-Program-Agency-Finances-Reinstatement-Of-FifthYear-Offset-Funds MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments https://medtech.pharmaintelligence.informa.com/MT143859/MDUFA-V-FDA-And-Industry-Still-At-Odds-Over-Carryover-Funds-Vacancies-Meeting-Commitments