FDA expands premarket medical device cyber guidance

The Food and Drug Administration (FDA) has published new final guidance on the cybersecurity controls for new medical devices. The new document, which replaces previous guidance issued in September 2023, provides FDA’s latest recommendations for cybersecurity device design, labeling and the information most device makers must now include in their premarket submissions to the agency.

The new guidance – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – reflects the FDA’s expanded authority over medical device cybersecurity that Congress granted the agency through an omnibus funding bill signed into law by then President Joe Biden in December 2022.

That bill amended the longtime Federal Food, Drug and Cosmetic Act by adding Section 524B – Ensuring Cybersecurity of Devices, which contains an array of cybersecurity requirements that manufacturers must include in the premarket submissions of products that meet the definition of a “cyber device,” such as a product that can connect to the internet

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