The FDA and representatives from the medical device industry and laboratory community have struck a deal in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Per the long-standing 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.
Under 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 funding would provide critical resources to the FDA medical device review program. 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.
“[The Medical Device User Fee Agreement] (MDUFA) IV is the result of more than a year of public input and negotiations with industry, laboratory, patient, and consumer representatives,” says Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “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.”
Shuren adds that this funding will “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.”