Lexology October 23, 2023
Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on cybersecurity in medical devices for quality system considerations and on premarket submissions. The guidance is intended to replace the FDA’s 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
In the introduction to the guidance, the FDA acknowledged the increase in integration of wireless, Internet-, and network-connected capabilities in portable media and the frequent exchange of medical device-related health information, which created a need for more “robust cybersecurity controls to ensure medical device safety and effectiveness . . . .”
The guidance...
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