FDA Finalizing Notice-To-Industry Policy, Amid Concerns
This article was originally published in The Gray Sheet
Executive SummaryDevice makers see benefit in FDA’s plan to issue “notice to industry” letters when it wants to communicate policy changes quickly, but industry reps emphasize that FDA should not overuse the approach.
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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.