About the FDA Signal Management Program
FDA’s Center for Devices and Radiological Health (CDRH) established a process for the evaluation of signals that support a new causal association or a new aspect of a known association between a medical device and an adverse event or set of adverse events. The program was piloted beginning in October, 2012. Discrete signal review teams, consisting of staff who reviewed the types of devices included in the pilot, were formed and began meeting regularly to prioritize, refine, and address new safety signals using a new set of milestones and timeframes.
In December 2014 FDA published guidance on ”Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)”. An emerging signal is defined in the guidance as 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 and/or the known benefit-risk profile of the device.
As a more complete understanding of the signal develops, the signal management team, with managerial input and oversight, identifies public health and/or regulatory actions to mitigate the identified risks, if any.
FDA considers many factors in the course of evaluating and notifying the public about emerging signals about medical devices. This assessment does not focus on hypothetical benefits and risks, but rather on benefits and risks whose existence and characteristics are supported by scientific evidence.
CDRH staff intends to strongly consider public notification about an emerging signal when all of the following statements apply:
- The information supports a new causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes.
- The available evidence is of sufficient strength.
- The information could have important clinical implications for patient management decisions and/or could significantly impact the known benefit-risk profile of the device.
Updates to the public notification should be posted to the FDA website at least twice per year, or more often as necessary and appropriate (e.g., following receipt of new substantive information), until the signal evaluation is completed and the public is notified of the Agency’s conclusions.