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Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

The FDA has released guidance on cybersecurity in medical devices to confront increasing cyber incidents, especially in the healthcare industry. The guidance, which supersedes its 2014 version, focuses on addressing cybersecurity considerations in device safety and effectiveness, and premarket submissions. It provides recommendations on testing connected devices, developing management plans, and producing updateability views. The FDA will host a webinar discussing the new guidance on November 2, 2023.

Source: www.lexology.com –

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