Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff January 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2017-D-6569
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research; Center for Drug Evaluation and Research

Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C Act. This guidance clarifies FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”). This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software functions.

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