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fda approach to regulating cds

FDA Regulatory Approach

FDA Regulatory Approach to Clinical Decision Support Software

-by Dalia Givony-

The need for Clinical Decision Support (CDS) tools using digital solutions and AI is rapidly growing and thier benefits are clear.

In this emerging technologies market there are CDS tools that follow the clinician’s prescriptions and notify the user via a pop-up alerts;  CDS tool which analyze patient physiological parameters to enable doctors to take optimal therapy decisions among varieties of provided treatment schemes; CDS system based on AI and medical imaging processing that improve breast cancer early detection, etc.

Many medical device companies develop CDS tools aiming to improve clinical practice and health outcomes.

But which tools are subject to FDA medical device regulation (Device CDS) and which tools are exempt from the regulation (Non-Device CDS)?

FDA guidance from 2022 provides an insight on the way FDA intends to regulate CDS.

NON-device CDS:

FDA excludes from the definition of device (hence are not subject to medical device regulation) software functions that meet all of the following four criteria:

  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 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.

Below are some examples of Non- Device CDS software:

  • Software function that provides a list of diagnostic and treatment order options to an HCP based on clinical guidelines for the care of adult patients presenting with pneumonia symptoms.

  • Matching patient-specific medical information from records or reports to reference information (e.g., clinical guidelines) that is routinely used in clinical practice.

  • Contextually relevant reference information about a disease or condition: Software function that provides HCPs with available treatment options, including drug, device, surgical and/or lifestyle changes for heart failure patients based on their disease stage and clinical guidelines.

  • List of preventive, diagnostic or treatment options: Software function that provides to an HCP a list of FDA-approved chemotherapeutic agents for a cancer type identified through analysis of medical information on the patient’s diagnosis and pathologist confirmed biopsy result.

  • Prioritized list of preventive, diagnostic or treatment options: Software function that analyzes patient-specific symptoms to provide a prioritized list of diagnostic tests for the HCP to consider.


All 4 criteria must be met to be defied as Non-Device CDS. Special attention should be given to criterion 4- the software labeling and function must provide information to enable HCPs to independently review the basis for the recommendations presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment


Examples of Device Software Functions:

  • Software function that uses a patient’s image sets (e.g., CT, MRI) to create an individual treatment plan for review by an HCP for patients undergoing radiation therapy treatment with external beam or brachytherapy.

  • Software function that identifies patients with possible diagnosis of opioid addiction based on analysis of patient-specific medical information, family history, prescription patterns, and geographical data.

  • Software function that analyzes near-infrared camera images of a patient intended for use in determining or diagnosing brain hematoma.

  • AI based software function that analyzes patient-specific medical information found in the medical record, including mammography report findings, in order to provide a list of follow-up options for the HCP to consider following a patient’s annual mammogram. This software is a device CDS if no additional information is available to the HCP to understand the key variables that influenced the recommendations, i.e it does not meet criterion 4 for Non- Device CDS.

  • Software functions that support or provide recommendations to patients or caregivers – not HCPs – meet the definition of a device CDS. 


If you need assistance in defining the regulatory strategy for CDS don't hesitate to contact us. 

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