CDRH Industry: Final Guidance: Public Notification of Emerging Postmarket Medical Device Signals

This morning the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) posted final guidance on Public Notification of Emerging Postmarket Medical Device Signals.  This guidance is intended to clarify CDRH’s policy for when we will publicly share information about emerging signals.  Timely notification about emerging signals is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices.

This guidance document can be found here: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479248.pdf

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health