FDA-CDRH Issues Final Guidance Document on Emerging Signals

On December 14, 2016, FDA-CDRH issued a final guidance document, UCM479248, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”).

The guidance document describes the FDA-CDRH policy for notifying the public about medical device about medical device emerging signals. The guidance document describes and emerging signal as new information:

  1. that 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
  2. for which the Agency 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.

The guidance document explains that the contents of an emerging signal public notification may vary depending on the type of information available and the specific benefits and risks of the impacted device(s). The public information should include:

  • a description of the device(s) to which the public notification applies;
  • a summary of the emerging signal, including the objective evidence on which the decision to issue a public notification is based;
  • information on the known benefits and risks of the device and its use.