Public Invited To Vet Draft User-Fee Agreement At Nov. 2 Meeting
The public will have a chance to discuss the tentative deal US FDA struck with industry to collect almost $1bn over five years in the next iteration of the device user-fee program at a statutorily-mandated meeting scheduled for Nov. 2.
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Prior to a Nov. 2 public meeting on the tentative MDUFA IV deal between FDA and industry, the agency released its proposed commitment letter and new details on the structure of user fees in the deal, including an increased 510(k) rate, more protection for small businesses and a new fee for de novo submissions.
More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.