FDA’s Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

April 24, 2019 – On October 18, 2018 the U.S. Food and Drug Administration issued a draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which provides updated recommendations to industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk.