FDA Clinical Decision Support Software Guidance

Clinical decision support software provides information or recommendations to support healthcare decisions. FDA’s guidance explains how the agency assesses software functions under the applicable statutory criteria. Some functions may be excluded from the device definition when they meet specific conditions, including that a health professional can independently review the basis for recommendations. Other functions, including certain patient-specific analyses or device functions, may remain subject to oversight. The assessment is about what a particular software function does, its intended user, and how the output is used. A product can contain multiple functions with different regulatory status. A tool that presents evidence for a clinician to review is not automatically treated the same as software that directs diagnosis or treatment. FDA guidance also notes that functions intended for patients or caregivers may be assessed differently from clinician-facing support. Manufacturers should define each function and provide information that supports independent review where relevant. Clinicians should understand what inputs and evidence support a recommendation, the intended population, and limitations. A generated explanation is not itself proof of the underlying basis. Check current FDA guidance and product labeling for the specific function. This guide summarizes concepts and does not determine regulatory status for a product. Preserve examples of intended use and evidence that support the analysis, and revisit it when users, claims, or outputs change. Keep patient-facing and clinician-facing functions distinct in requirements and documentation.