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DEVICE USER FEE CHARGES FOR PMA SUPPLEMENTS WITH CLINICAL DATA CUT 84%

This article was originally published in The Gray Sheet

Executive Summary

DEVICE USER FEE CHARGES FOR PMA SUPPLEMENTS WITH CLINICAL DATA CUT 84%, to $9,000, under a revised draft of device user fee legislation, according to congressional staffers and industry reps involved in negotiations on the bill. The initial draft of the measure, released April 15, would have set a fee of $55,000 for premarket approval supplements that include clinical data required by FDA ("The Gray Sheet" April 18, p. 3).
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