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Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices | Jackson Lewis P.C.

The U.S. FDA issued guidance on cybersecurity in medical devices on September 27, 2023, in response to rising cyber incidents, particularly in the healthcare sector. The guidance, which replaces the 2014 premarket submissions content, offers recommendations to ensure robust cybersecurity controls for device safety and effectiveness. It emphasizes premarket submissions should outline security objectives and confirms cybersecurity falls under device safety and quality system requirements.

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