FDA issues final guidance on ’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.

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).

Get the full story on our sister site, Medical Design & Outsourcing.

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