FDA Guidance on Cybersecurity in Medical Devices

On September 26, 2023 FDA issues final guidance on Cybersecurity in Medical Devices: Quality System Consideration and Content of Premarket Submissions. This final guidance follows the draft guidance issues in 2022 and FDA’s Refusal To Accept policy issued in March 27 2023. The new Cybersecurity guidance replaces the 2014 guidance and is much more detailed than its predecessor. FDA will now required companies submitting for IDE, 510K or PMA details about cybersecurity measures developed as part of the device design and measures developed as part of the Quality Management Systems to keep the design safe once its on the market

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