FDA Issues Finalized Clinical Decision Support (CDS) Software Guidance

FDA, 19 Jan 2026 — The FDA issued a finalized version of its guidance, “Clinical Decision Support Software“ On January 6, 2026. This document supersedes the previous version issued in September 2022 and provides the Agency’s current thinking on which software functions are excluded from the definition of a “medical device” under section 520(o)(1)(E) of […]