Total FDA medical device user fees will double, funding more than one-third of the agency’s device pre-market review efforts, under a tentative agreement for a five-year reauthorization announced last week.
The pact, announced Feb
Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees
The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.