FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Increases Efforts to Flag Public Warnings, Recalls

Feb. 21, 2019

FDA Commissioner Scott Gottlieb announced last week that the agency is ramping up its efforts to improve public warnings and recall notifications.

The agency has finalized guidance on when companies should issue public warnings about recalls, including a timeframe for issuing them.

The guidance also describes information that should be included in the warnings and circumstances when the agency can issue its own warning if the company’s is inadequate.

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