The Food and Drug Administration (FDA or the Agency) is responsible for protecting and promoting the public health. This includes helping the public get the accurate, science-based information they need about medical products to maintain and improve their health. At the time a medical device is approved or cleared, it has a benefit-risk profile that health care providers, patients, and consumers use to make patient management decisions. Once a medical device is on the market, new information, including unanticipated problems, may change the benefit-risk profile of a device.
FDA is issuing this guidance to describe the Center for Devices and Radiological Health’s (CDRH) policy for notifying the public about medical device “emerging signals.” For the purposes of this 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 and/or the known benefit-risk profile of the device. Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.
This guidance describes the factors 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. 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. Public notification at an early stage may reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated, and may promote enhanced vigilance on the part of clinicians, risk managers, patients and consumers. This awareness may assist in the recognition of an adverse event before more serious complications or sequelae occur.