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FDA Cybersecurity Requirements for Medical Devices Now in Effect

From the HIPAA Journal:

On Wednesday, March 29, 2023, the medical device cybersecurity requirements of the $1.7 trillion omnibus spending bill – The Consolidated Appropriations Act, 2023 – took effect and the FDA now requires all regulatory submissions for medical devices to include information about the cybersecurity measures that have been implemented for the devices. Section 3305 of the Omnibus bill — Ensuring Cybersecurity of Medical Devices — amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices. This requirement took effect 90 days after the enactment of the Act on December 29, 2022, which means premarket submissions submitted to the FDA after March 29, 2023, require information to be included about the cybersecurity of medical devices.