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FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity considerations for medical devices to assist device manufacturers in preparing premarket submissions.

Released in late September, the Final Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” provides recommendations on cybersecurity device design, labeling, and documentation that the FDA recommends be included in premarket submissions for medical devices that pose a potential cybersecurity risk.

The Final Guidance also recommends that device manufacturers consider adopting a secure product development framework (SPDF), a set of processes aimed at reducing the number and severity of potential vulnerabilities in a given device throughout the device’s entire lifecycle.

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Read the complete text of the FDA’s Final Guidance on medical device cybersecurity quality system considerations.

The FDA will host a webinar on the Final Guidance in early November for those interested in learning more about the agency’s recommendations on cybersecurity considerations for medical devices.

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