Search Results for MDUFA IV

Showing 1 – 9

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

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

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo

Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018 By Zachary Brennan - Published 28 August 2017

Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements.

Categories: News, US, FDA, Business and Leadership, Compliance, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug user fees, medical device user fees, MDUFA IV, GDUFA II

HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees By Zachary Brennan - Published 17 May 2017

Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Tom Price, MDUFA IV, BsUFA II, PDUFA VI, GDUFA, user fees

FDA Seeks Input on Device Accreditation Pilot By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions.

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

Tags: Accreditation Scheme for Conformity Assessment, ASCA, MDUFA IV, Consensus Standards

CDRH Plots Path to New 'Progressive' Approvals for Some Devices By Zachary Brennan - Published 03 May 2017

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.

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

Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices

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: Negotiations Step Forward, But Gaps Remain By Michael Mezher - Published 26 May 2016

The medical device industry is calling for the US Food and Drug Administration (FDA) to add 91 new employees as part of the latest talks over the next version of the Medical Device User Fee Act (MDUFA), though industry also says it needs more information on several recent FDA proposals.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDUFA IV

FDA, Industry See Progress in MDUFA IV Negotiations By Zachary Brennan - Published 30 October 2015

At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction.

Categories: Business Skills, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDUFA IV, user fees, IDEs, Q-submissions, MDMA, MITA, AdvaMed, ACLA, Booz Allen

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