On December 31, 2015, FDA published a draft guidance describing the Agency’s policy for notifying the public about medical device “emerging signals”.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. This type of communication is executed in a variety of ways (recall notices, safety communications, press releases), and after FDA has completed an analysis of available data, and typically after making 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, FDA believes there is also 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 with the Agency does not yet have specific recommendations. FDA states that this timely communication about emerging signals provides “health care providers, patients, and consumers with access to the most current information concerning the potential benefits and risks of marketed medical devices so that they can make informed treatment choices based on all available information.”
This draft guidance is conceptually similar to the draft guidances entitled, “Classifying Significant Postmarketing Drug Safety Issues” and “Drug Safety Information–FDA’s Communication to the Public,” both published in 2012. However, this device-related draft guidance makes no provision for advance notification to the sponsor before information about an emerging device signal is made public.