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DEVICE USER FEES OF $3,200 PER 510(k) AND $52,000 PER PMA PROPOSED

This article was originally published in The Gray Sheet

Executive Summary

DEVICE USER FEES OF $3,200 PER 510(k) AND $52,000 PER PMA PROPOSED in the most recent draft of the medical device user fee bill, dated June 30. The fees represent a 22% drop for 510(k) charges from the May 17 version of the bill, and a 16% decrease for PMA charges ("The Gray Sheet" May 23, p. 2).
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