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The U.S. Food and Drug Administration (FDA) published a draft guidance titled Cybersecurity in medical devices: Quality system considerations and content of premarket submissions. The final version of the guide will: (1) Offer recommendations to the industry on cybersecurity considerations for devices, (2) Help the industry identify issues related to Cybersecurity in the design and development of their medical devices, and (3) Provide recommendations for documentation in device premarket submissions. The deadline for public comments is July 7, 2022.
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