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CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role

This article was originally published in The Gray Sheet

Executive Summary

In an interview, CDRH Director Jeffrey Shuren detailed plans for new guidance documents and process changes at the device center focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.

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

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