MDUFA IV Fees Unveiled: Changes For 510(k)s, Small Business, De Novos
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.
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Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.
US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals
The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.
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.