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News/Cyber & AI/FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers
Expert Opinion·Cyber & AI Brief

FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers

On April 8, the FDA released a draft guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” If finalized, it would replace FDA’s 2014 final guidance document.

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