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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