FDA-CDRH issued the final guidance document UCM479248 Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) on December 14, 2016. The guidance describes the policy for public notification of emerging signals. An emerging signal, based on the guidance has two attributes:
- It supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and
- FDA has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device
Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.