FDA has issued guidance on publicising medical device “emerging signals” that will see healthcare professionals, the public and consumers receive timely information on medical device risks and potential risks.
The guidance describes the processes and timelines to be followed internal when issuing and updating medical device “emerging signals” notifications. Under the guidance, FDA will notify the public about information that supports a new causal association, 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.
These announcements are to ensure that healthcare providers and patients have up-to-date information about medical devices and can make individual patient management choices. The notifications will not mean that FDA has determined that there is a causal relationship between the medical device and the emerging signal, nor that FDA is advising healthcare providers and patients to limit use of a particular device. However, the guidance says that “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.”
FDA considers many factors in the course of evaluating and notifying the public about emerging signals about medical devices. Announcements will only be made when reliable scientific evidence supports a new causal relationship and the agency needs additional time to reach a definitive conclusion or make recommendations. What the agency knows and does not know, is to be clearly stated in the notifications.
The contents of an emerging signal public notification may vary depending on the type of information available and the specific benefits and risks of the affected device. In general, a public notification regarding an emerging signal for a medical device 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.
It is important to understand that whilst it is expected that affected companies will interact with FDA during the signal management process, and FDA will inform the affected companies shortly before issuing a public notification, the guidance permits the FDA to deliver a notification without informing all manufacturers if there is a risk of patient harm or it is impossible to contact some companies in the time available.
To read the guidance, please click here