In a draft guidance for industry and staff issued on December 31, the FDA proposed notifying the public about medical device “emerging signals that the agency is monitoring or analyzing, and for which the agency does not yet have specific recommendations" of possible device risk.
Timely communication about emerging signals is intended to provide health care providers, patients, and consumers with access to the most current information concerning the potential benefits and risks of marketed medical devices so that they can make informed treatment choices based on all available information.
The public has 60 days to comment.