Search Results for medical device user fee

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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

MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA By Zachary Brennan - Published 26 October 2016

The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA, medical device user fee, user fee proposal

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

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

Medical Device User Fees Set to Drop in 2015, But Not by Much By Alexander Gaffney, RAC - Published 30 July 2014

The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDUFA, FDASIA, Medical Device User Fee, 2015 Medical Device User Fee