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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.

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. 1, is more than companies had wanted to spend, but industry negotiators insist it is a...

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