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September 29, 2015



House Speaker John Boehner Retiring From Congress

Price Leads Letter to CMS on Bundled Payments

What We’re Reading

AAOS and Others Urge Delay in Meaningful Use

PQRS Informal Review Process

Senate Continues HIT Hearings

Patient and Consumer Stakeholder Meeting - MDUFA Reauthorization, September 15, 2015

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Patient and Consumer Stakeholder Meeting - MDUFA Reauthorization, September 15, 2015

The Federal Drug Administration (FDA) is hosting a series of meetings that will be held regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA) IV.  During these meetings, participants will hear updates on the FDA-Industry negotiations and will provide their suggestions for improving the program. 

Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), and 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III). In 2015, the FDA is discussing the 2017 medical device user fee program (MDUFA IV) with industry.

Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.

On September 15, 2015, FDA held the first patient and consumer stakeholder meeting to discuss the reauthorization of MDUFA.  The FDA gave insight into their performance commitments and funding and how that has evolved since 2003.  The progress in performance goals is increasing the efficiency of pre-market programs.  The FDA presented trends that showed that there is increased submission of Investigational Device Exemption (IDE) and decreased review times.  The FDA is focusing on improving the infrastructure and expanding opportunities for patient perspectives. 

Breakout groups were formed to discuss what topics should be discussed in the upcoming meetings.  From that discussion, a few of the main discussion points with FDA were increasing specific data analysis to the FDA, expanded access pathway and making sure there are resources, the parallel review process, better understanding of post-market surveillance, dialogue with industry, incorporating patient perspectives, patient reported outcomes and user fees (implications) and cross center review. 

Additional meetings will be held on October 26, 2015, November 30, 2015, December 18, 2015, January 11, 2016 and February 16, 2016.