1. FDA Guidance for Industry and FDA Staff Summary of Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)
Effective: December 14, 2016
This summary was prepared by the Rx-360 Monitoring and Reporting Working Group which tracks regulatory, legislative and policy developments relevant to pharmaceutical/medical device supply chain integrity. The summary is not intended to serve as comprehensive and formal interpretation or guidance (and should not replace your own review and analysis of any referenced source documents). If you have questions, please contact Brittany Tobery, Rx-360 Secretariat, at or

2. I. Introduction and III. Scope
Emerging Signal = new information about a marketed medical device:
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
For which the Agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device.
Emerging Signal ≠ Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.
Timely notification about Emerging Signals is intended to:
Make the most current performance and benefits/risks information concerning marketed medical devices available to end users to make informed patient management decisions.
Help reduce/limit the number of patients exposed to the potential risk while the issue is being further evaluated, and enhanced vigilance on the part of clinicians, risk managers, patients and consumers.
Recognition of an adverse event before more serious complications occur.
The guidance describes the factors that CDRH 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.
Guidance does NOT apply to IDEs (21 CFR 812).

3. II. Background Process includes:
FDA recognizes that postmarket use provides useful real-world information on device use and performance
Types of information to be looked at:
newly recognized type of adverse event associated with a medical device
an increase in the severity or frequency of a known adverse event
new product-product interactions
device malfunctions or patient injuries potentially related to improper device use or design
a reduction in benefit to the patient
Process includes:
Collecting available information from multiple sources
Interaction with impacted device company(ies)
Review by SME multidisciplinary team
Other stakeholder engagement
Management oversight

4. IV. Signal and Signal Management
General CDRH signal management process:
Information received about device-related signals
Examples of Signal sources provided, e.g.: MDRs, MedSun Network reports, mandated postmarket studies data, clinical trials, scientific literature, etc.
CDRH signal management team convened and perform:
Signal refinement and characterization process:
CDRH seeks a to understand the fundamental nature of the observed adverse event/newly identified risk
The likelihood of a causal relationship between the device use and the adverse event/risk
Conduct a preliminary assessment as to whether the issue is limited (e.g., to one device model or one manufacturer) or has a broader impact
Identifies public health and/or regulatory actions to mitigate the identified risk(s)

5. V. Considerations of Determining When FDA Should Issue a Public Notification About an Emerging Signal
CDRH to apply specific factors to improve consistency, transparency, and predictability for vetting signals, for example, e.g., likelihood of the harmful event(s); magnitude (severity), duration, and reversibility of the harmful event(s); magnitude of the benefit; etc.
Decision to provide public information does not mean the FDA:
Has concluded there is a causal relationship between device use & emerging signal
Is advising end users to limit their use of the device
Specific actions are expected by the manufacturer at that time
CDRH will consider public notification when all conditions apply:
Information supports a new causal association, or a new aspect of a known association between a medical device and one or more adverse events or clinical outcomes
Available evidence is of sufficient strength
Information could have important clinical implications and/or could significantly impact the known benefit-risk profile of the device.
CDRH intend to initiate an assessment of the need for public notification within 30 days of receiving information

6. VI. Content of Public Notification and Follow-up/Closure
Public notification required information:
Device description to which the public notification applies
Summary of the emerging signal
Information on the known benefits/risks of the device and its use
FDA will inform the impacted company(ies) shortly before issuing the public notification, unless time does not permit due to the risk of patient harm or it is otherwise not feasible
Following issuance of a public notification, the FDA will update when:
Provide additional information collected
Notify that no additional substantive information or change to benefits/risks has occurred
Notify that additional actions by the FDA or manufacturer have taken place
FDA has completed its evaluation and determined that additional regulatory or public health actions are not needed
Updates to the public notification should be posted to the FDA Website at least 2 times/year

7. Thank you
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