FDA proposes early warning system for medical devices

Editor's Note

The Food and Drug Administration (FDA), on December 31, 2015, released draft guidance on “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).”

The draft proposes a policy for how the FDA will notify the public about “emerging signals” (ie, new information) of possible device risks before the risks are fully analyzed, validated or confirmed, and for which the agency does not yet have specific recommendations.

In the past, the FDA has communicated postmarket device information after completing an analysis of data, and reaching a decision about user recommendations and whether further regulatory action is warranted. Comments on the draft will be received for 60 days.

Today the FDA released a draft guidance document Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"). This document proposes a policy for how the FDA will notify the public about medical device "emerging signals."