FDA, industry reach tentative deal on MDUFA reauthorization

FDA and the medical device industry reached an agreement in principle on MDUFA reauthorization that would allow the agency to collect $595 million in user fees for FY2013-17. FDA was seeking a user fee package of up to $805 million, while industry wanted $447 million. The figure would more than double the $287 million FDA received in user fees for FY08-12 under the current MDUFA. The funding bump would allow FDA to add over 200 full-time employees to review applications, the majority of whom would be placed in the Office of Device Evaluation and the Office of In Vitro Diagnostics.

The deal also includes measureable performance goals to improve the agency's review process for devices, including a target to improve the agency's average total time to decision over the five year period. According to minutes from a meeting on Tuesday between FDA and industry, the agency has a goal by FY17 to issue a decision on 95% of 510(k) applications within 90 business days. ...