FDA proposes early warning system for medical device safety issues

FDA proposes early warning system for potential medical device safety issues
The Food and Drug Administration (FDA) has issued draft guidance that would establish an early warning system to alert the public to possible safety issues with medical devices before the agency has investigated whether a serious risk actually exists.

The FDA currently issues press releases, recalls and safety communications to alert the public of safety concerns after a device has entered the market. These alerts are released after the FDA has investigated the issue and determined what to do about it. The administration system says an "emerging signals" system can help to subvert potential harm as an investigation is being completed.

The FDA notice states that "timely communication about emerging signals is intended to provide health care providers, patients and consumers with access to the most current information concerning the potential benefits and risks of marketed devices, so that they can make informed treatment choices based on all available information. Such communication also may reduce or limit the number of patients exposed to the potential risk while the issue is being evaluated further.

According to the draft guidance, the FDA will consider a number of factors when determining whether an issue should be identified as an emerging signal, including the seriousness of the adverse event and the strength of evidence showing a causal relationship between using the device and the adverse event.

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