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# Guidance on Notifying Public of Postmarket Device Info
- URL: https://www.fdaweb.com/guidance-on-notifying-public-of-postmarket-device-info/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134316

*Federal Register* Notice: FDA is making available a draft guidance entitled *Public Notification of Emerging Postmarket Medical Device Signals*. It describes the agency’s policy for notifying the public about medical device “emerging signals.” Historically, 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. However, in addition to these types of public communications, FDA believes 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 it does not yet have specific recommendations. To download this draft guidance, click [here.](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479248?ref=fdaweb.com) To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2015-12-31/pdf/2015-32920.pdf?ref=fdaweb.com)