The FDA issued a guidance, Clinical Decision Support Software, to describe the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. The graphic below provides a visual overview of the guidance.
Disclaimer: This graphic gives a general overview of Section IV of the guidance (“Interpretation of Criteria in Section 520(o)(1)(E) of the FD&C Act”). Consult the guidance for the complete discussion. The device examples identified in this graphic are illustrative only and are not an exhaustive list. Other software functions that are not listed may also be device software functions.
Text Version of Graphic
Your Clinical Decision Support Software: Is It a Device?
The FDA issued a guidance, Clinical Decision Support Software, to describe FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. This graphic gives a general and summary overview of the guidance and is for illustrative purposes only. Consult the guidance for the complete discussion and examples. Other software functions that are not listed may also be device software functions.
Your software function must meet all four criteria to be considered Non-Device CDS.
Summary Interpretation of CDS Criteria
- Your software function does NOT acquire, process, or analyze medical images, signals, or patterns.
- Your software function displays, analyzes, or prints medical information normally communicated between health care professionals (HCPs).
- Your software function provides recommendations (information/options) to a HCP rather than provide a specific output or directive.
- Your software function provides the basis of the recommendations so that the HCP does not rely primarily on any recommendations to make a decision.
If all four criteria are met, your software function may be non-device CDS.
According to criteria 1 and 2: Non-Device examples display, analyze, or print the following examples of medical information, which must also not be images, signals, or patterns:
- Information whose relevance to a clinical decision is well understood
- A single discrete test result that is clinically meaningful
- Report from imaging study
According to criterion 3, non-device examples provide:
- Lists of preventive, diagnostic, or treatment options
- Clinical guidances matched to patient-specific medical info
- Relevant reference information about a disease or condition
According to criterion 4, non-device examples for provide:
- Plain language descriptions of the software purpose, medical input, underlying algorithm
- Relevant patient-specific information and other knowns/unknowns for consideration
Your software function must meet all four criteria to be Non-Device CDS.
According to criterion 1: Device examples acquire, process, or analyze:
- Signal acquisition systems
- In vitro diagnostics
- Magnetic resonance imaging (MRI)
- Next Generation Sequencing (NGS)
- Continuous Glucose Monitoring (CGM)
- Computer aided detection/diagnosis (CADe/CADx)
According to criterion 2: Device examples display, analyze, or print:
- Continuous signals/patterns
- Medical images
- Waveforms (ECG)
- More continuous sampling (aka – a signal or pattern)
According to criterion 3: Device examples provide:
- Risk scores for disease or condition
- Probability of disease or condition
- Time-critical outputs
According to criterion 4: Device examples:
- Basis of recommendations is not provided
If any one of the 4 criteria is not met, your software function is a device.