The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effective includes adequate medical device cybersecurity, as well as its security as part of the larger system. In 2018, FDA proposed updates to the final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and issued a draft guidance of the same name. This draft guidance replaces the 2018 draft guidance. This draft guidance is intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns. This draft guidance is not final nor is it for implementation at this time…
