FDA Updates Guidance on Clinical Decision Support (CDS) Software for Healthcare Professionals
The FDA has released an updated guidance clarifying which Clinical Decision Support (CDS) software functions fall outside its definition of a medical device. This clarification significantly impacts developers and manufacturers creating or marketing CDS tools for healthcare professionals.
On January 6, 2026, the U.S. Food and Drug Administration (FDA) published its revised guidance document: “Clinical Decision Support Software – Guidance for Industry and FDA Staff”, which supersedes the previous 2022 version. This update aims to further clarify the regulatory status of software intended to support clinical decision-making by healthcare professionals (HCPs).
The document explains the FDA’s interpretation of Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which excludes certain CDS software functions from the definition of a medical device—provided four specific criteria are met.
These four criteria are:
The software does not acquire, process, or analyze medical images or signals from in vitro diagnostic devices.
It is intended to display, analyze, or print medical information, such as clinical studies or patient data.
It supports or provides recommendations to HCPs on prevention, diagnosis, or treatment—but does not replace clinical judgment.
It enables HCPs to independently review the basis for the recommendations, ensuring they do not rely primarily on the software to make clinical decisions.
Where these conditions are met, the software is classified as “Non-Device CDS” and falls outside FDA device regulation. Otherwise, the software may be regulated as a medical device, including requirements for premarket submission and labeling.
The guidance also provides detailed examples of both device and non-device software functions, including decision support tools related to:
Treatment recommendations
Diagnostic aids
Risk calculators
Follow-up planning tools
For manufacturers and developers, understanding the distinction between regulated and unregulated CDS functions is essential to determining whether compliance with FDA’s device requirements is necessary.
You can access the full guidance here.
