Navigating the Medical Device User Fee Act (MDUFA)

Posted 25 May 2017 By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA

placeholder+image This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

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Categories: Medical Devices, Submission and registration, Features, US, CDRH

Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees

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