FDA Publishes Updated Guidance on Clinical Decision Support Software
On 29 January 2026, the U.S. Food and Drug Administration (FDA) issued an updated guidance document entitled “Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff”. This document supersedes the guidance issued on 6 January 2026 and reflects FDA’s current thinking on the regulation of clinical decision support (CDS) software.
The guidance applies to CDS software intended for use by healthcare professionals (HCPs) and describes FDA’s interpretation of which CDS software functions are excluded from the definition of a medical device under U.S. law.
Legal and regulatory context
The guidance is based on Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act. Under this provision, certain software functions are excluded from the device definition if all four statutory criteria are met.
FDA states that software functions that do not meet all four criteria remain medical devices and are subject to FDA oversight. The guidance also notes that some products may contain multiple software functions, including both device and non-device functions, and refers to FDA’s existing policy on multiple function device products.
Criteria for exclusion from the device definition
According to the guidance, a CDS software function is excluded from the definition of a device only if it meets all of the following criteria:
The software function is not intended to acquire, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system.
The software function is intended to display, analyze, or print medical information about a patient or other medical information, such as peer-reviewed clinical studies or clinical practice guidelines.
The software function is intended to support or provide recommendations to a healthcare professional about the prevention, diagnosis, or treatment of a disease or condition.
The software function is intended to enable the healthcare professional to independently review the basis for the recommendations, so that the healthcare professional does not rely primarily on the software’s recommendations to make a clinical diagnosis or treatment decision for an individual patient.
The guidance states that all four criteria must be met for a software function to be considered Non-Device CDS.
Description of Criterion 4
The guidance includes detailed descriptions related to the fourth criterion. FDA states that, to enable independent review, the software or its labeling should provide information such as:
The intended use, intended healthcare professional user, and intended patient population
Identification of the required input medical information and its relevance
A plain-language description of the development and validation of the underlying algorithm
Information about the data relied upon and the results of clinical studies used to support the recommendations
Relevant patient-specific information, including known limitations or missing data
FDA also states that software functions intended for critical, time-sensitive tasks or decisions do not meet this criterion, because the healthcare professional is unlikely to have sufficient time to independently review the basis for the recommendations.
Examples included in the guidance
The guidance provides extensive examples of:
Non-Device CDS software functions, provided that all four criteria are met; and
Software functions that remain medical devices, where one or more of the criteria are not satisfied.
These examples cover a wide range of software functionalities, including software that displays medical information, supports clinical recommendations, analyzes medical images or signals, or provides diagnostic or treatment outputs.
Status of the guidance
FDA states that this guidance document represents the Agency’s current thinking on clinical decision support software. It does not establish legally enforceable responsibilities and is not binding on FDA or the public. Alternative approaches may be used if they comply with applicable statutory and regulatory requirements.
Read the full document below.
