Translated with AI
The evolution of digital health has blurred the lines between IT tools and Medical Devices. A key reference for navigating this landscape is the FDA guidance published on January 6, 2026, in its second update: “Clinical Decision Support Software – Guidance for Industry and FDA Staff”.
The document clarifies when a Clinical Decision Support (CDS) software function is or is not regulated as a medical device – specifically as Software as a Medical Device (SaMD) – under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Compared to the 2022 version, the guidance provides additional examples and clarifications on the distinction between Device CDS and Non-Device CDS.
What is Clinical Decision Support Software (CDS)?
A CDS is a computer system that provides Health Care Professionals (HCPs), patients, or caregivers with information to support decisions about diagnosis, treatment, or management of diseases or medical conditions. This is achieved through alerts, patient-specific therapeutic suggestions, or data and image analysis. Examples range from hospital software flagging dangerous drug-drug interactions to mobile apps suggesting questions for a patient to ask their physician based on symptoms.
However, not all CDS software intended for clinical decisions meets the statutory definition of a medical device subject to FDA oversight.
Non-Device CDS: The Four Statutory Exclusion Criteria
A CDS software function is not considered a medical device if it meets all four of the following exclusion criteria simultaneously:
- No Analysis of Medical Images or Signals
The software must not acquire, process, or analyze medical images or signals from In Vitro Diagnostic (IVD) devices or data acquisition systems (e.g., raw ECG waveforms). - Display or Analysis of Medical Information Only
The function must be limited to displaying, analyzing, or printing medical information about a patient or other existing clinical information (e.g., peer-reviewed clinical studies, historical vital signs, or previously processed laboratory results). - Support for, Not Replacement of, Clinical Judgment
The purpose must be solely to provide patient-specific recommendations for a disease or condition without replacing or directing the healthcare professional’s judgment. - Independent Review by the Professional
The software must provide sufficient information to allow HCP to independently review the basis for the recommendations, ensuring they do not rely primarily on the software’s output to make a clinical decision.
When Software is Classified as a Medical Device (Device CDS)
Software falls under FDA regulation when its function involves higher risk or delegates the clinical decision-making process.
The 2026 guidance highlights key scenarios:
- Intended for patients and caregivers: if the software provides diagnostic or therapeutic recommendations directly to a layperson without the critical mediation of an HCP, it almost always meets the definition of a medical device.
- Time-Critical conditions: systems intended to manage emergencies or acute conditions (e.g., real-time stroke or sepsis detection) are Medical Devices, as the time-sensitive nature precludes the HCP from performing an independent review of the data.
- Processing of signals and images: any software that processes outputs from sensors or imaging systems to generate a diagnosis is regulated as a device.
Conclusions
As outlined, software intended for physicians that presents relevant information without providing a single, mandatory therapeutic directive may qualify as a Non-Device CDS.
In such cases, algorithmic transparency is paramount: the output must be accompanied by a clear explanation of the underlying logic, allowing the professional to verify the evidence and make an autonomous decision. Regulation ensures that clinical software remains a tool for human intelligence, keeping the final responsibility for care in expert, informed hands.
Thema offers strategic regulatory support for the correct qualification of Software as a Medical Device and assists manufacturers in achieving full regulatory compliance.
SOURCE:
Clinical Decision Support Software | FDA
Publication date: 26/01/2026
