FDA Issues Draft Guidance on “Emerging Signals” Notifications for Medical Devices

January 5, 2016–The US Food and Drug Administration (FDA) announced last week the availability of a draft guidance entitled, “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’).”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. The announcement was published in the Federal Register (2015;80:81829–81830).

According to the FDA, the agency has historically 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, the FDA believes 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 This draft guidance is not final nor is it in effect at this time, advised the agency.

Information for accessing the complete draft guidance and for submitting comments to the FDA is available online. To ensure that the agency considers comments of this draft guidance before it begins work on the final version of the guidance, electronic or written comments should be submitted by February 29, 2016.