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FDA Guidance, Clinical Decision Support Software(CDS)

February 22 2023




The US Food and Drug Administration has released final guidance for clinical decision software (CDS) functions, providing clarity on which functions will regulate medical devices.


These four criteria describe the types of CDS that are not regulated as devices:


1. Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system


2. Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information


3. Intended for the purpose of supporting or providing recommendations to an HCP about the prevention, diagnosis, or treatment of a disease or condition


4. Intended for the purpose of enabling an HCP to independently review the basis for the recommendations that such software presents so that it is not the intent that the HCP rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient




This graphic below provides a visual overview of this guidance:




The FDA regulates CDS software functions:


  • Analyze medical data and provide treatment recommendations. This includes functions that use algorithms and other computational tools to analyze medical data, such as laboratory test results, imaging studies, and patient history, and provide treatment recommendations to healthcare professionals.


  • Display or visualize medical data: This includes functions that display or visualize medical data in a way that supports clinical decision-making, such as graphs, charts, and other visual aids.


  • Facilitate communication between healthcare professionals: This includes functions that enable communication between healthcare professionals for the purpose of making treatment decisions, such as telemedicine platforms and electronic consult systems.



The FDA not regulates CDS software functions that:


  • Provide patient-specific diagnosis or treatment recommendations: This includes functions that provide specific diagnosis or treatment recommendations directly to patients, without the involvement of a healthcare professional.


  • Provide patient-specific recommendations for population health management: This includes functions that provide recommendations for population health management, such as public health surveillance and disease tracking.




For more information, see the https://www.fda.gov/guidance


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