On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical Decision Support Software” (the “CDS Guidance”). The CDS Guidance follows the Agency’s September 2019 draft guidance of the same name (the “Draft Guidance”) and seeks to clarify several key concepts for determining whether clinical decision support (“CDS”) software is a medical device.
Specifically, the CDS Guidance provides the Agency’s interpretation of the four criteria established by the 21st Century Cures Act for determining whether a decision support software function is excluded from the definition of a device (i.e., is considered “Non-Device CDS”). A software function must meet all of the following four criteria to be considered Non-Device CDS:
- Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device (“IVD”) or a pattern or signal from a signal acquisition system
- Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
- Intended for the purpose of supporting or providing recommendations to a health care professional (“HCP”) about prevention, diagnosis, or treatment of a disease or condition
- Intended for the purpose of enabling such 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
Software functions that do not meet all four criteria are considered device functions subject to FDA oversight. Notable updates to FDA’s interpretation of the four criteria include the following.
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