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Regulatory Focus™ > News Articles > FDA Outlines Medical Device Real-World Evidence User Fee Proposal

FDA Outlines Medical Device Real-World Evidence User Fee Proposal

Posted 23 May 2016 | By Zachary Brennan 

FDA Outlines Medical Device Real-World Evidence User Fee Proposal

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).

The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III.

In a meeting on 25 April (the meeting minutes were released Friday), FDA gave patient and consumer stakeholders a high-level description of its RWE user fee proposal, which includes the addition of 15 full-time employees to develop and implement a framework for using RWE for premarket decision-making as part of work at a new medical device coordinating center.

In February, FDA proposed the addition of 20 full-time employees as part of the five-year, $500 million MDUFA reauthorization.

The latest proposal includes $10 million per year, which would help establish and operate the coordinating center and projects to improve RWE data sources and increase their use.

“FDA emphasized that the user fee investment will yield better quality registries so the data can be used in premarket regulatory decision-making and will provide the opportunity to nest clinical trials in registries, which is one way to reduce the cost of evidence generation,” according to the meeting minutes. “FDA shared some of the concerns industry expressed regarding the use of user fees to pay for the coordinating center and related projects, and whether the benefits of the system would be broadly based and during the MDUFA IV timeframe. FDA explained that the coordinating center could develop a self-sustaining funding model, and that FDA believes the benefits of the system could be available to the entire industry because a broad range of companies can benefit from lower costs to generate evidence and earlier marketing authorization through the premarket/postmarket shift.”

The agency also explained that RWE has been used previously in both premarket and postmarket regulatory decisions, including for post-approval studies, continued access studies, labeling extension studies and postmarket surveillance studies.

National Evaluation System

In addition to the RWE proposal, FDA presented information on its progress in establishing a national evaluation system for tracking the postmarket issues linked to medical devices.

“FDA described the investments made by the agency between 2011 and 2015 that included the establishment of the Unique Device Identifier (UDI) system and 50 projects that were conducted over that time that have included the creation or improvement of RWE data sources. FDA explained that approximately $20 million and significant staff time has been invested to lay the foundation for a national evaluation system for medical devices,” according to the minutes.

The agency has been working with a planning board to help develop the organizational structure and governance model of the national evaluation system’s coordinating center, a financial plan for sustainability and an implementation plan.

“FDA stated that the selection and operation of a coordinating center for a national evaluation system depends on securing funding, either from congressional budget authority appropriations, private-sector funds, or a combination of both,” according to the minutes.

Patient and Consumer Stakeholder Meeting on MDUFA IV Reauthorization



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