Clinical Decision Support Software Functions: Device vs Non-Device Classification
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 based on the criteria in section 520(o)(1)(E) of the FD&C Act. The guidance applies to CDS software intended for healthcare professionals (HCPs) and explains how FDA determines whether a CDS software function is a non-device or remains subject to FDA oversight.
What You Need to Know? 👇
What are the four criteria that Clinical Decision Support software must meet to be excluded from FDA device regulation?
CDS software must: (1) not acquire/process/analyze medical images or signals from IVDs, (2) display/analyze medical information, (3) provide recommendations to HCPs about patient care, and (4) enable HCPs to independently review the recommendation basis without relying primarily on the software for clinical decisions.
How does FDA distinguish between medical information and signals/patterns in CDS software regulation?
Medical information includes discrete test results, reports, and clinical data that can be communicated between HCPs. Signals/patterns involve continuous sampling or multiple sequential measurements from devices like ECGs or continuous glucose monitors. Single discrete measurements are medical information; continuous sampling creates patterns/signals.
Can Clinical Decision Support software provide specific treatment recommendations and still be non-device?
No. Software providing specific preventive, diagnostic, or treatment outputs/directives fails Criterion 3. Non-device CDS must provide lists of options or recommendations that support HCP decision-making without directing them to specific actions or replacing their clinical judgment.
What information must CDS software provide to enable independent HCP review under Criterion 4?
Software must provide: intended use and user information, required input medical information with quality requirements, plain language algorithm description including development/validation data, and relevant patient-specific information with known/unknown factors to enable independent HCP assessment of recommendations.
Does FDA regulate Clinical Decision Support software intended for patients or caregivers?
Yes. CDS software intended for patients or caregivers meets the device definition and remains subject to FDA regulation. The section 520(o)(1)(E) exclusion only applies to CDS software specifically intended for healthcare professionals (HCPs).
How does sampling frequency affect whether CDS software is considered a device?
Sampling frequency determines if data is medical information or a signal/pattern. Single discrete measurements (like one blood glucose test) are medical information. Continuous or frequent sampling (like continuous glucose monitoring every 30 minutes) creates patterns/signals, making the software a device.
What You Need to Do 👇
Recommended Actions
- Evaluate software against the four criteria to determine if it qualifies as non-device CDS
- Document how software meets each criterion:
- No image/signal analysis
- Medical information display/analysis
- HCP recommendations only
- Independent review capability
- Prepare comprehensive labeling including:
- Clear intended use statement
- Input requirements
- Algorithm description
- Validation information
- Conduct usability testing if needed to verify independent review capability
- Ensure software does not:
- Direct specific clinical decisions
- Support time-critical decisions
- Target patient/caregiver users
- Maintain documentation of how recommendations are supported by evidence
- Implement process to keep medical information sources up-to-date
- Consider FDA consultation if unclear about device/non-device status
Key Considerations
Human Factors
- Usability testing may be needed to evaluate if CDS implementation meets Criterion 4 (enabling HCP to independently review the basis for recommendations)
Software
- Must meet all four criteria to be considered non-device CDS:
- Not intended to acquire, process, or analyze medical images/signals
- Intended to display, analyze, or print medical information
- Intended to support/provide recommendations to HCPs
- Enables HCP to independently review recommendation basis
- Software must not be intended for time-critical decision-making
- Software must not provide specific diagnostic or treatment directives
Labelling
- Must clearly identify intended use, HCP user, and patient population
- Must identify required input medical information and data quality requirements
- Must provide plain language description of algorithm development and validation
- Must describe limitations and considerations for use
Other considerations
- Must provide sufficient information about basis of recommendations
- Must enable independent evaluation by HCP
- Must not be intended for patient/caregiver use (these remain devices)
- Must not support time-critical decision making
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
Original guidance
- Clinical Decision Support Software Functions: Device vs Non-Device Classification
- HTML / PDF
- Issue date: 2022-09-28
- Last changed date: 2025-02-03
- Status: FINAL
- Official FDA topics: Administrative / Procedural, Biologics, Medical Devices, Drugs, Digital Health
- ReguVirta ID: 1b9ce7391d030e8583d42c97162b3b4d