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510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014

This article was originally published in The Gray Sheet

Executive Summary

CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.

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