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Device Week – Episode 22

This article was originally published in The Gray Sheet

Executive Summary

On this week's podcast, "Gray Sheet" journalists talk about a new Smart template FDA is rolling out to guide 510(k) reviews, the agency's shift in approach to encourage a "critical-to-quality" focus by companies, recent Government Accountability Office findings on device postapproval studies and what CDRH chief Jeff Shuren has to say about FDA versus EU regulations.

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