User fees have been a bone of contention between the medical device industry and the U.S. Food and Drug Administration, and negotiations have dragged on for a year. Now, a tentative deal has been reached. The FDA announced Wednesday that in exchange for agreeing to shorter review periods for 510(k) applications and other performance improvements, the FDA is getting $595 million over five years from … Comments RSS Post a comment. No comments yet.

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Medical device user fees will be $595M as part of preliminary deal …