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FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk.

fda.gov

The FDA’S Role in Medical Device Cybersecurity

Dispelling myths and understanding facts about medical device software regulations, responsibilities, and testing.

fda.gov

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Guidance intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk.

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The FDA’S Role in Medical Device Cybersecurity

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

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