Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:
"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."
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