FDA, 19 Jan 2026 — The FDA issued a finalized version of its guidance, “Clinical Decision Support Software“ On January 6, 2026. This document supersedes the previous version issued in September 2022 and provides the Agency’s current thinking on which software functions are excluded from the definition of a “medical device” under section 520(o)(1)(E) of the FD&C Act.
The 2026 update signals a shift toward promoting digital health innovation by offering more flexibility for AI-enabled tools, particularly regarding single recommendations and clinical documentation.
CLINICAL DECISION SUPPORT (CDS) : KEY INTERPRETATIONS OF THE FOUR CRITERIA
To qualify as Non-Device CDS (and thus remain unregulated as a device), a software function must meet all four statutory criteria:
- Criterion 1: No Signal Processing. The software must not acquire, process, or analyze medical images, signals from in vitro diagnostics, or patterns from signal acquisition systems. The 2026 guidance clarifies that “discrete, episodic, or intermittent” measurements (like routine vitals) generally do not constitute a “pattern”.
- Criterion 2: Medical Information. The software must be intended to display, analyze, or print “medical information” about a patient (e.g., test results, clinical studies, or guidelines).
- Criterion 3: Supporting HCP Decisions. The software must provide recommendations to a healthcare professional (HCP) about prevention, diagnosis, or treatment. It must not replace or direct the HCP’s judgment.
- Criterion 4: Independent Review. The software must enable the HCP to independently review the basis for the recommendations so they do not rely primarily on the software for clinical decisions.
TARGETED ENFORCEMENT DISCRETION IN CLINICAL DECISION SUPPORT (CDS)
The most significant change in the 2026 version is the expansion of discretion in law enforcement for specific low-risk scenarios that technically fall outside the Non-Device CDS definition:
- Single Recommendations: FDA now intends to exercise enforcement discretion for tools that provide a singular output (rather than a list of options) when only one recommendation is clinically appropriate. For example, recommending a specific antibiotic based on symptoms and history may now fall under this discretion.
- Generative AI & Documentation: Software that analyzes a radiologist’s findings to generate a proposed summary or diagnostic recommendation may fall under enforcement discretion, provided it does not analyze the underlying image itself.
- General Wellness Expansion: Parallel updates to the General Wellness Policy allow non-invasive wearables (e.g., reporting blood pressure or glucose-related signals) to remain unregulated if framed strictly for wellness and paired with non-diagnostic notifications.
WHAT THIS MEANS FOR MANUFACTURERS
Manufacturers should immediately reassess their portfolios against these 2026 criteria. While the path is now easier for “single recommendation” AI features, the key gating factor remains explainability. To satisfy Criterion 4, labeling must use “plain language” to describe the algorithm’s general approach, logic, and the datasets used for validation.
RESOURCES
- FDA Final Guidance: Clinical Decision Support Software (Jan 2026)
- Related Policy: General Wellness: Policy for Low Risk Devices (Jan 2026)
- Multiple Function Policy: Multiple Function Device Products: Policy and Considerations.