> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Medical Device Signal Guidance
- URL: https://www.fdaweb.com/medical-device-signal-guidance/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134291

> CDRH has issued a draft guidance, *Public Notification of Emerging Postmarket Medical Device Signals*, describing FDA’s policy for notifying the public about medical device “emerging signals.” For purposes of the [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479248.pdf?ref=fdaweb.com), an emerging signal is defined as new information about a medical device used in clinical practice **(1)** that the agency is monitoring or analyzing, **(2)** that has the potential to affect patient management decisions and/or change the device’s known risk/benefit profile, **(3)** that has not yet been fully validated or confirmed, and **(4)** for which the agency does not yet have specific recommendations.  
>  
> Historically, the document says, FDA has communicated important medical device postmarket information after having completed an analysis of available data and, in most cases, after having reached a decision about relevant recommendations for the device user community and about whether further regulatory action is warranted.  
>  
> “For safety or effectiveness issues, FDA generally will provide new or amended advice or instructions for patients and/or consumers regarding the safe and effective use of the device, based on the new data,” the guidance says. “In these cases, the agency uses a variety of mechanisms to communicate publicly, including recall notices, safety communications, and press releases. However, in addition to these types of public communications, we believe there also is a need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations.”