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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Upcoming workshop will help manufacturers understand when they should submit a new 510(k) for changes to an existing product. CDRH plans to extend early feasibility pilot until May 2014. More regulatory news.

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Regulatory News In Brief

FDA issues two FDASIA-mandated reports to Congress – one on underrepresented subpopulations and the second on small businesses. More regulatory news.

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