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FDA Medical Devices Cybersecurity

The US Food and Drug Administration (FDA) has released updated guidance on cybersecurity in medical devices, amid rising cyber incidents in the healthcare sector. The guidance details how to integrate cybersecurity into device design to ensure safety and effectiveness, and provides advice on testing, labeling, and managing cybersecurity risks. It replaces the FDA’s 2014 protocols and will be discussed further in a webinar on November 2, 2023.

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