FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical Devices

By US Dept. Health


This report from the U.S. Department of Health And Human Services, offers insight into how the FDA has taken steps to address emerging cybersecurity concerns in networked medical devices by issuing guidance, reviewing cybersecurity information in submissions, and—when needed—obtaining additional information from manufacturers. It also discusses how the FDA could take additional steps to more fully integrate cybersecurity into its premarket review process.

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