FDA and ‘emerging signals’: what you need to know

FDA Emerging Signals

[Image courtesy of OiMax on Flickr, per Creative Commons 2.0 license]

FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week.

The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to FDA that releasing emerging signals information could cause “unnecessary confusion” and cause health providers and their patients to avoid medical devices that were safe and useful.

At the same time, patient safety advocates have criticized FDA for failing to promptly report potentially deadly problems with medical devices. In one of the more egregious examples, FDA and device maker Olympus may have dragged their feet warning the U.S. public that a widely used Olympus endoscope was linked to deadly superbug outbreaks between 2012 and 2015, according to an early 2016 report from the office of Sen. Patty Murray, D-WA.

The final guidance from FDA seeks to strike a balance between the needs of industry and the needs of patients, says Scott Mitreuter, product manager at quality management services provider Sparta Systems (Hamilton, NJ).

“I’d say the industry, in particular the manufacturers, would be worried that the FDA could be portraying their products in a negative light, prior to full and lengthy investigations being completed. … The FDA addressed this in the guidance by being specific in what it will include in public notification, and their process for validating the information, and only using the information if the data is sound and verifiable,” Mitreuter said.

FDA spells out in the guidance document: “Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.”

There are two cases where FDA says it would issue an early public warning about a medical device;

  • The agency has credible scientific evidence supporting a causal relationship between a medical device and adverse events, but still needs time for additional analysis before making a conclusion.
  • FDA has concluded that there is a causal relationship but needs more time to develop recommendations to address the problem.

The staff at FDA’s Center for Devices and Radiological Health will make a decision about whether to publicly release emerging signal information within 30 days of receiving the initial information that generated the signal, according to the guidance document. If new or substantive information comes to their attention, the CDRH staff will internally review the previous decision within 30 days.

Says FDA: “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.”

MDO senior editor Heather Thompson contributed to this article.

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