FDA Publishes Draft Cybersecurity Guidance For Medical Devices

Earlier this month, the Food and Drug Administration ("FDA") issued Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This draft guidance document, which replaces the prior 2018 draft guidance, is "intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging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."

It is a reflection of the FDA's assessment that "[a]s 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."