The U.S. Food and Drug Administration (FDA) recently released a statement on a recent agreement in principle that it has tentatively reached with leaders in the medical-device industry and laboratory community concerning the latest Medical Device User Fee Agreement (MDUFA).
The leaders have created proposed recommendations so that the MDUFA program can be reauthorized for a fourth time.
Under the new proposal, the FDA would receive authorization to gather $999.5 million from user fees, as well as inflationary adjustments for the next five years, beginning in October 2017.
The new MDUFA should benefit consumers, an FDA official said.
“MDUFA IV is the result of more than a year of public input and negotiations with industry, laboratory, patient and consumer representatives,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “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 life cycle, such as registries, electronic health records, and other digital sources.”
Further details on the agreement will be made public at a future time. The final recommendations will be made in front of Congress in January.
