FDA Reaches Agreement with Industry for Reauthorization of Medical Device User Fees

The Food and Drug Administration has issued a statement announcing that 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 the medical device user fee program (MDUFA IV).

Under the new draft agreement (to be published in the coming weeks), the FDA would be authorized to collect almost $1 billion in user fees over five years starting in October 2017.  This funding would provide critical resources to the FDA medical device review program.

The director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., has commented:

This draft agreement represents a substantial investment in the future of the agency’s medical device program and reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices.  This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.

First established in 2002 to provide the FDA with the resources necessary to better review medical devices, device user fees have helped 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.  These fees, which range from the thousands to hundreds of thousands depending on the type of review required, are paid by medical device companies when they register their establishments and list their devices with the agency or submit an application or a notification to market a new medical device in the U.S.

The current legislative authority for the medical device user fee program expires on October 1, 2017, and new legislation will be required for the FDA to continue collecting user fees for the medical device program in future fiscal years.

Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.

Chang Lim
Chang Lim is an associate in the firm's Orange County Office. Chang practices intellectual property law, with a focus on patent counseling and protection of electronics and software technologies. During law school, Chang served as an editor of the Journal of Law and Public Policy. Prior to joining Knobbe Martens, he was an associate at an intellectual property boutique law firm in New York.
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