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August 30, 2016



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MDUFA Reauthorization Updates

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MDUFA Reauthorization Updates

The Federal Drug Administration (FDA) hosted a series of meetings regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA) IV over the past year.  During these meetings, participants heard updates on the FDA-Industry negotiations and provided their suggestions for improving the program. 

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.  The last MDUFA bill, enacted in 2012, doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA.

As of August 22, 2016, the FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee programUnder the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017.   This is a 68% increase from that last reauthorization in 2012. 

The new agreement is the first to include metrics aimed at reducing review times, increased interaction with FDA staff before and during reviews and a pair of independent analyses of how the FDA manages the medical device approval process.  MDUFA IV will give FDA resources to hire additional reviewers and to fund IT and infrastructure improvements, such as the Quality Management System and Digital Health.  The agreement would reduce the total review times for devices, require two independent analyses of how FDA manages the review process and enhance FDA’s reporting requirements.

The industry cited other wins from negotiations: an FDA commitment to give companies feedback at least five days before meetings about forthcoming applications and funding for a pilot project known as the National Evaluation System to test how “real-world evidence” can be used to support pre-market activities.  This agreement of principle will be published in the Federal Register the middle of October with a 30 day comment period.  There is also a Public Meeting that will be scheduled for November 2, 2016.