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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Upcoming IOM 510(k) meetings: The Institute of Medicine task force commissioned to review FDA's 510(k) pre-market submissions program will hold its next two public meetings on June 14-15 and July 28 in Washington, D.C., the agency announced. The workshops will help IOM gather information to inform recommendations for potential reforms of the 510(k) program. IOM held its first 510(k) meeting March 1(1"The Gray Sheet" March 8, 2010)

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