FDA Clinical Decision Support Software – Final Guidance

29th January 2026

Summary: The FDA’s Clinical Decision Support Software document is a final guidance that clarifies how CDS — software intended to assist clinical decision-making — is treated under U.S. law. It describes criteria under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act that determine when CDS functions are not considered medical devices (and therefore not subject to FDA device requirements). The guidance explains that for software to qualify as non-device CDS, it must meet all statutory criteria (e.g., allow independent review of the basis for its recommendations). It also clarifies that software functions that do not meet the limits of the exemption are regulated as devices, and FDA’s existing digital health policies apply to these functions. The guidance provides examples to illustrate the distinction between non-device CDS and device software functions, helping developers and regulators make consistent assessments.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

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