The extra $320.5m (plus inflation) in medical device user fees the US FDA plans to collect during the five fiscal years beginning in 2018 will help fund several completely new review performance goal categories, upgrades to some existing goals, and a range of structural and process enhancements at the agency.
New details about planned MDUFA IV user-fee commitments have emerged since FDA and industry announced an agreement "in principle" on Aug. 22 that would authorize the agency to collect a...