The Food and Drug Administration has issued draft guidance for industry and FDA staff on the management of cybersecurity for medical devices. The guidance will be finalized after a 150-day comment period, and will supersede the 2014 guidance on the same topic. The FDA also announced a memorandum of agreement with the Department of Homeland Security to increase coordination and cooperation in addressing cybersecurity in medical devices.
October 18, 2018
FDA and DHS coordinate, issue new draft guidance on medical device cybersecurity
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