2023 FDA Medical Device Security Requirements

10 April 2023 by Phillip JohnstonIncluded in the U.S. 2023 Consolidated Appropriations Act (H.R. 2617) (the “spending bill”) were new cybersecurity regulations for U.S. medical devices. Sec. 3305 of the bill, Ensuring Cybersecurity of Medical Devices, adds a new section to the Federal Food, Drug, and Cosmetic Act: “524B. Ensuring Cybersecurity of Devices”. New Requirements If your medical device can connect to the internet, or contains software that could be vulnerable to cybersecurity threats in some way, your FDA applications will now need to include information that shows your company: Has a plan to monitor, identify, and address, in a …

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