Posted 13 December 2016
By Zachary Brennan
The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA).
Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to have the potential to impact patient management decisions.
“The decision to provide public information about an emerging signal is intended to give health care providers, patients, and consumers access to the most current information about a device that may help inform their patient management decision making. It does not mean that FDA has definitively concluded that there is a causal relationship between the medical device and the emerging signal; nor does a public notification about the emerging signal mean that FDA is advising health care providers, patients, or consumers to limit their use of the device,” the guidance says.
The finalization of the guidance follows pressure from industry to try to quell these new public notifications by FDA of device events or other issues that might end up becoming incorrect, incomplete or misleading. Industry group AdvaMed took issue with FDA’s failure to “articulate a reasonable basis to communicate emerging signals to the public.”
The 8-page guidance notes that FDA’s Center for Devices and Radiological Health (CDRH) does not intend to release information publicly unless:
- “Credible scientific evidence supports a new causal relationship, but the agency needs additional time to reach a more definitive conclusion, for example by conducting additional analyses,” or
- FDA has concluded that a causal relationship exists but the agency needs additional time to develop recommendations. The guidance adds that FDA’s communications should be clear about what the agency knows and does not know, as well as whether the agency recommends specific actions and why.
Public notifications on emerging signal for medical devices will include:
- A description of the device(s) to which the public notification applies
- A summary of the emerging signal, including the objective evidence on which the decision to issue a public notification is based
- Information on the known benefits and risks of the device and its use
The guidance also says that in addition to interacting with an impacted company or companies during the signal management process, FDA will inform these firms shortly before issuing a public notification, “unless time does not permit because of the risk of patient harm or it is not feasible, e.g., CDRH is not able to reach all manufacturers.”
Updates to the public notification should be posted to the FDA website at least twice per year, the guidance says, or more often as necessary and appropriate until the signal evaluation is completed and the public is notified of the agency’s conclusions.
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”): Guidance for Industry and Food and Drug Administration Staff