MDUFA IV is coming your way in 2017. It may cost you more money and calls for real-world evidence (RWE).
MDUFA stands for the Medical Device User Fee Act. MDUFA comprises a substantial part of the FDA’s budget to review, clear or approve applications from industry to bring new devices to market. Negotiations take place between the FDA and industry, where industry promises to pay and the FDA promises to meet review time standards. Industry, through its trade association, AdvaMed, has praised the FDA for improving most measures of timely reviews and approvals of applications under the program.
In 2002, the Medical Device User Fee and Modernization Act (MDUFMA) was passed, which introduced the first user fees for medical devices. The fees are subject to reauthorization every five years. User fees were renewed in 2007 and again in 2012. In 2017, user fees will be re-authorized for the fourth time since its implementation. The FDA kicked off the reauthorization negotiations by holding a public meeting on the subject in July 2015.
The latest negotiation, according to RAPS (Regulatory Affairs Professional Society), includes a proposal from the FDA to link new fees to RWE. The FDA proposal is part of the agency’s bid to raise fees by $329 million above the cost of MDUFA III. The FDA proposal, in part, adds 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 minutes released from an April 25, 2016 meeting between industry and the agency, the 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.”
“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.”
According to RAPS, the agency 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.
The FDA also presented information at the April meeting on its progress in establishing a national evaluation system for tracking the postmarket issues linked to medical devices.
According to the minutes, “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.”
Negotiations continue between industry, the agency and other stakeholders.
