The Food and Drug Administration (FDA) has announced final guidelines for Clinical Decision Support Software. The “Clinical Decision Support Software (CDS) Guidance” supplements the Agency’s proposed guidance of the same name issued in September 2019 (the Draft Guidance) and attempts to clarify many essential principles for establishing whether or not a specific CDS software is a medical device.
The CDS Guidance, in particular, offers the Agency’s explanation of the four criteria for evaluating if a decision support software function is excluded from the definition of a device (i.e., is classified as “Non-Device CDS”). To be deemed Non-Device CDS, a software operation must fulfill all four standards:
1) It is not designed for the acquisition, processing, or analysis of a medical image or signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.
2) It is intended to display, analyze, or print a patient’s medical information, usually discussed between healthcare practitioners.
3) Rather than providing a specific result or direction, the software function makes recommendations to healthcare professionals concerning prevention, diagnosis, or treatment.
4) It is intended to allow health care professionals to independently assess the rationale for the recommendations that this software offers so that the health care provider does not rely only on any of such recommendations to make a clinical diagnosis or treatment choice for an individual patient.
The guidance covers the FDA’s interpretive approach comprehensively, including an assortment of factors and aspects that will significantly contribute to determining whether CDS software is a device subject to FDA oversight or not, and includes an array of examples of the device and non-device CDS.
