Search Results for Medical Device User Fee Act

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Navigating the Medical Device User Fee Act (MDUFA) By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 25 May 2017

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.

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

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

Lead MDUFA Negotiator Details Changes in MDUFA IV Financing By Michael Mezher - Published 02 November 2016

The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday.

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

Tags: MDUFA IV, Medical Device User Fee Act

FDA Outlines Medical Device Real-World Evidence User Fee Proposal By Zachary Brennan - Published 23 May 2016

Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE).

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance

Tags: MDUFA, Medical Device User Fee Act, real-world evidence and medical devices

FDA Kicks Off MDUFA Reauthorization Process By Alexander Gaffney, RAC - Published 18 May 2015

The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities.

Categories: News, US, CDRH, Medical Devices

Tags: MDUFA, Medical Device User Fee Act, MDUFA IV