Shuren Defends Tentative User Fee Agreement On The Hill
This article was originally published in The Gray Sheet
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.
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The agency published its draft commitment letter and draft legislative language for user fee reauthorization March 15. A public meeting is set for the end of the month, and public comments will be accepted through April 16.