In January 2026, the U.S. Food and Drug Administration (FDA) issued an updated final guidance on clinical decision support (CDS) software, providing much-needed clarity for health technology developers navigating an increasingly complex regulatory landscape. The guidance interprets provisions of the 21st Century Cures Act that exclude certain CDS software functions from the definition of a “device,” thereby exempting them from FDA premarket review requirements.
The Four Criteria for Non-Device Clinical Decision Support (CDS) Software
Under Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FDCA), a clinical decision support software function may qualify as a “Non-Device CDS,” thereby avoiding FDA device regulation where it satisfies all four of the following criteria:
- Criterion 1: No Medical Image or Signal Analysis. The software must not be 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 (such as ECG leads or continuous glucose monitors). As the statute itself provides, if the software uses these data types as inputs, it remains a regulated device regardless of whether the other criteria are met. The FDA interprets the term “medical image” to include images generated by medical imaging systems, such as computed tomography (CT), X-ray, ultrasound, magnetic resonance imaging (MRI), and others that view any part(s) of the body or images acquired for a medical purpose (e.g. pathology, dermatology).
- Criterion 2: Display, Analyze, or Print Medical Information. The software must be intended to display, analyze, or print medical information about a patient or other medical information, such as peer-reviewed clinical studies, clinical practice guidelines, or patient-specific information from electronic health records. This criterion effectively delineates the types of data inputs appropriate for Non-Device CDS, as distinguished from the nonpermitted signal-based inputs described in Criterion 1.
- Criterion 3: Provide Recommendations to Healthcare Professionals. The software must be intended to support or provide recommendations to a healthcare professional (HCP) about the prevention, diagnosis, or treatment of a disease or condition. Importantly, the software must not be designed to replace or direct the HCP’s clinical judgment; rather, it should enhance and inform clinical decision-making by offering options or recommendations for the HCP to consider.
- Criterion 4: Enable Independent Review by the HCP. The software must be intended to enable the HCP to independently review the basis for the recommendations it presents, such that the HCP does not rely primarily on those recommendations to make a clinical diagnosis or treatment decision. To satisfy this criterion, the FDA recommends that the software or labeling identify the intended use, patient population, required inputs, and a plain-language description of the underlying algorithm development and validation.
FDA Updated Guidance on Non-Device Clinical Decision Support (CDS) Software
The 2026 guidance makes several notable adjustments. Perhaps most significantly, the FDA previously required CDS software to output multiple recommendations (i.e., a list of options) to qualify as Non-Device CDS. This interpretation was often criticized as forcing developers to build artificial choice into tools where clinical guidelines pointed to a single best path.
The guidance now states that if only one option is “clinically appropriate” and the software otherwise meets the other three criteria, the FDA intends to exercise enforcement discretion (meaning the FDA does not intend to enforce the requirements under the FDCA) for such functions. The FDA guidance provides illustrative examples of software functions that are Non-Device CDS software functions and examples of software functions that remain devices.
Implications for Health Tech Software Developers
These developments arrive at a critical inflection point for digital health. The guidance provides clarity on longstanding ambiguities, particularly regarding the boundaries of permissible clinical decision support functionality. At the same time, developers should note that the guidance does not directly address many emerging AI-enabled tools, including clinical documentation assistants and medical chatbots. The FDA’s relative silence on AI may signal that AI-specific guidance is forthcoming.
In sum, the updated FDA CDS guidance reflects the agency’s effort to reduce regulatory friction while maintaining oversight of higher-risk software functions. In light of this, companies developing CDS software should carefully evaluate whether their products satisfy all four statutory criteria and should remain vigilant as the regulatory landscape continues to evolve.
How Frier Levitt Can Help
Frier Levitt regularly counsels digital and health tech companies on FDA compliance, as well as related regulatory and data privacy concerns. Our attorneys help clients navigate the evolving regulatory landscape for clinical decision support software, AI-enabled health tools, and other digital health products. Whether you are assessing whether your software qualifies as Non-Device CDS, or addressing broader compliance obligations, our team provides strategic guidance tailored to your business objectives.
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