On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the public on “emerging signals” regarding medical devices that are already used in clinical practice.  The FDA defined an emerging signal as “new information about a medical device” that:

  1. The Agency is monitoring or analyzing
  2. Has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
  3. Has not been fully validated or confirmed
  4. For which the Agency does not yet have specific recommendations