Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

Article preview from "The Gray Sheet"-  February 6, 2012

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.

Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees

Article preview from "The Gray Sheet"-  February 6, 2012

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 good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in devices reaching the U.S. market.

Meanwhile, the agreement “in principle” falls short of what FDA was pushing for throughout the past year of negotiations. As a result, some priority areas for industry, including improved pre-submission interactions, will not receive dedicated resources, according to minutes released by FDA from the Jan. 31 user fee negotiation meeting where the deal was finalized.

Industry fees to FDA will total $595 million from fiscal 2013 through 2017, enabling the device center to hire more than 200 additional employees. This more than doubles the $287 million in user fees paid in the current five-year program, which expires September 30.

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