The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices. FDA defines an emerging signal as “new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”
An “emerging signal” would alert the public to the most current information known about a medical device. The intent is to prevent potential risk to patients. Opponents to this idea are asking why the FDA would release information that has not been fully verified / investigated by the FDA. For more information, read Zachary Brennan’s article on RAPS.org.