Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals').'' This guidance describes the Agency's policy for notifying the public about medical device ``emerging signals.'' Historically, FDA has communicated important medical device postmarket information after having completed an analysis of available data and, in most cases, after having reached a decision about relevant recommendations for the device user community and about whether further regulatory action is warranted. However, in addition to these types of public communications, we believe there also is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations. This draft guidance is not final nor is it in effect at this time.