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# Final Guidance on Device Emerging Signals
- URL: https://www.fdaweb.com/final-guidance-on-device-emerging-signals/
- Published: 2016-12-13T12:00:00.000Z
- Updated: 2026-09-14T21:54:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137551

FDA has finalized a [guidance](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479248.pdf?ref=fdaweb.com) on “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) that describes CDRH’s policy for notifying the public about medical device “emerging signals.” According to the guidance, an emerging signal is new information about a marketed medical device: **1**) that supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and **2**) for which the agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions or the device’s known benefit-risk profile of the device. “Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal,” it says.

The guidance describes the factors the Center intends to consider in deciding whether to notify the public about an emerging signal, and the processes and timelines it should follow in issuing and updating the notification. “Timely notification about those emerging signals based on the factors described in this guidance document 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 so that they can make informed patient management decisions about their treatment and diagnostic options,” the agency says. The factors may include, but are not limited to, the following:

• Likelihood (probability) of the harmful event(s);

• Magnitude (severity), duration, and reversibility of the harmful event(s);

• Magnitude of the benefit (e.g., the degree to which a given condition, symptom or function is improved and whether the device provides life-sustaining or life-saving benefits);

• The quality of the data or information;

• The strength of the evidence of a causal relationship between the use of a device and the adverse event;

• Extent of patient exposure (e.g., how broadly is the device used, the duration of exposure, including whether the device is intended to be permanently implanted);

• Whether there is a disproportionate impact on vulnerable patient populations (e.g., children, pregnant women, elderly, cancer patients, chronically ill patients, at-home/unmonitored patients);

• Potential for preventing, identifying, monitoring or mitigating the risk

• Availability, risks, and benefits of alternative therapies;

• Potential for patients to not receive treatments they should even in light of the new information;

• Implications for similar or related devices (e.g., multiple models from multiple manufacturers);

• Anticipated time for completion of FDA’s assessment of the available information and development of recommendations; and

• Accuracy and availability of information already in the public domain.