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Industry, FDA Agree On Draft User Fee Commitment Letter

Executive Summary

Draft commitment and legislative language come one month after agreement “in principle” on MDUFA III reauthorization.

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FDA Agrees To Waive User Fees For Reviews Of Lab-Developed Tests

Although FDA is still developing its lab-developed test regulatory framework, it has agreed not to collect user fees to support its planned review of the tests.

Shuren Defends Tentative User Fee Agreement On The Hill

Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.

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.

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