FDA drafts ‘select updates’ to guidance on medical device cybersecurity, addressing statutory requirements

BY LAURA DIANGELO, MPH

In late 2023, the FDA finalized a long-awaited guidance on medical device cybersecurity – but also promised updates to that final guidance which would address certain statutory requirements. Today, the agency published a draft version of those “select updates,” which delineate how the FDA will interpret key statutory definitions and provide expectations for documentation and for bringing existing devices into compliance.

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