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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Minnesota lawmakers lobby Hamburg on 510(k) reform: Sen. Amy Klobuchar, D-Minn., and Rep. Erik Paulsen, R-Minn., sent a letter to FDA Commissioner Margaret Hamburg May 26 expressing concerns over potential changes to the 510(k) device clearance process and urging the commissioner to avoid modifications that would add "new and unnecessary regulations, resulting in an even longer and more complicated approval process." FDA is reviewing its 510(k) program internally, while the Institute of Medicine undertakes a concurrent 510(k) program review. CDRH is still compiling an internal report for Center Director Jeffrey Shuren. He could not predict when a copy of the report would be released publicly
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