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CDRH Tries Again On Proposal For Rapidly Communicating Policy Changes

This article was originally published in The Gray Sheet

Executive Summary

FDA’s device center has dropped previously proposed “notice-to-industry letter” terminology and abandoned the idea of sending out rapid-fire communications in anything but official guidance format in its new draft standard operating procedures on “Level 1 – immediately in effect” guidance. The document updates a 2011 SOP that faced pushback from companies.


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FDA Issues Policy For Making Immediate Changes To Device Submission Guidelines
FDA Finalizing Notice-To-Industry Policy, Amid Concerns
FDA Says Some Notice-To-Industry Letters Will Be Level 1 Guidance





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