FDA’s Guidance Concerning Its Refuse to Accept Policy for Cyber Devices

On March 30, 2023, FDA released the guidance document, “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act [Federal Food, Drug, and Cosmetic Act],” stating it would not issue a “Refuse to Accept” decision for marketing applications for cyber medical devices submitted before October 1, 2023, based only on information required by the new statutory provision (Section 524B).