FDA Issues Final Guidance: Public Notification of Emerging Postmarket Device Signals

FDA Law Blog recently reported that “Approximately one year ago, on New Years Eve [2015], FDA surprised the device industry with a draft guidance on emerging postmarket device signals. On December 14 [2016], FDA issued the final guidance document: Public Notification of Emerging Postmarket Device Signals (“Emerging Signals”)

FDA has made significant changes to the draft guidance, including a modified definition of “emerging signal,” a description of the process CDRH will follow in identifying and assessing emerging signals, and the prospect for interactions between industry and FDA as the Agency assesses emerging signals and decides whether to post a public notification announcing the emerging signal.” Click here for the December 2015 draft guidance, here for the new December 2016 final guidance and here to see the latest on medical device reporting requirements.