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CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

This article was originally published in The Gray Sheet

Executive Summary

CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.

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