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CDRH Tries Again On Proposal For Rapidly Communicating Policy Changes

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.

FDA has revised its proposal for rapidly communicating updated standards to device firms in new draft standard operating procedures. In particular, the agency has dropped the previously proposed “notice-to-industry letter” terminology and abandoned the idea of conducting such rapid-fire communications in anything but official guidance format.

Issued Sept. 5, the draft SOP describes the device center’s planned approach to creating and issuing “Level 1...

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