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FDA To Release Only Confirmed New Device Risk Data It Sees, Says Final Emerging Signals Guidance

Executive Summary

FDA Dec. 13 issued a final "emerging signals" guidance that includes some significant changes from the draft version released late last year. The update emphasizes that the agency will release to the public only confirmed information that it has seen on adverse events or other negative reports connected to a marketed medical device, which could change the product's risk profile.

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