FDA Updates Cybersecurity Guidance for Medical Device Makers

The Food and Drug Administration Sept. 26 finalized guidance updating the cybersecurity information device makers should submit to its Center for Devices and Radiological Health or Center for Biologics Evaluation and Research for premarket review of devices that have cybersecurity considerations. The recommendations are intended to help manufacturers meet their obligations under section 524B of the Federal Food, Drug, and Cosmetic Act, enacted in December 2022 as part of the Consolidated Appropriations Act of 2023, which defines “cyber device” as one that includes a device or software that can connect to the internet and be vulnerable to cybersecurity threats.