Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations

Citeline Podcasts

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