Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
This guidance clarifies FDA's regulatory approach to Clinical Decision Support (CDS) software functions, particularly focusing on which CDS software functions are excluded from the definition of a device under section 520(o)(1)(E) of the FD&C Act. The guidance specifically addresses CDS software intended for healthcare professionals (HCPs) and explains the criteria for determining whether a CDS software function is a non-device.
Recommended Actions
- Evaluate whether your CDS software meets all four criteria for non-device classification:
- Not analyzing medical images/signals
- Displaying/analyzing medical information
- Supporting/providing recommendations to HCPs
- Enabling independent review by HCPs
- Implement clear labeling that includes:
- Intended use and user population
- Input medical information requirements
- Algorithm development and validation description
- Clinical validation results
- Ensure software provides sufficient information for HCPs to independently review recommendations:
- Patient-specific information
- Known/unknown factors
- Data quality indicators
- Basis for recommendations
- Consider conducting usability testing to validate that implementation meets Criterion 4
- Review software functionality to ensure it’s not:
- Providing specific directives
- Supporting time-critical decisions
- Replacing HCP judgment
- Document how the software enables HCPs to independently review recommendation basis
- Maintain up-to-date sources and references used in the software
- Implement clear processes for updating medical information and algorithms
Key Considerations
Human Factors
- Software should enable HCPs to independently review the basis for recommendations
- HCPs should not rely primarily on recommendations to make clinical decisions
- Usability testing may be needed to evaluate if implementation meets Criterion 4
Labelling
- Must clearly identify intended use, HCP user, and patient population
- Should provide plain language description of algorithm development and validation
- Must identify required input medical information and data quality requirements
- Should describe results from clinical studies conducted to validate the algorithm
Software
- Must not be intended to acquire, process, or analyze medical images or signals from IVDs
- Must be intended for displaying, analyzing, or printing medical information
- Must provide recommendations to HCPs about prevention, diagnosis, or treatment
- Should not provide specific preventive, diagnostic, or treatment directives
- Should not be intended for time-critical decision-making
Safety
- Software should not be intended for time-critical tasks or decisions
- Should provide relevant patient-specific information and known/unknown factors
Other considerations
- Must enable HCPs to independently review basis for recommendations
- Should provide adequate background information in plain language
- Should identify relevant sources available to intended users
- Should describe how logic was applied for patient-specific recommendations
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Clinical Evaluation of Software as a Medical Device (SaMD)
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Policy for Device Software Functions and Mobile Medical Applications
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
Related references and norms
- IMDRF/SaMD WG/N12: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
Original guidance
- Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
- HTML / PDF
- Issue date: 2022-09-28
- Last changed date: 2022-09-27
- Status: FINAL
- Official FDA topics: Medical Devices, Digital Health, Drugs, Biologics, Administrative / Procedural
- ReguVirta summary file ID: 1b9ce7391d030e8583d42c97162b3b4d
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