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- FDA Down Classifies AI Software Algorithm Devices
On February 2, the Food and Drug Administration (FDA) published a final order where the agency down-classified software algorithm devices to assist in digital pathology to class II. This action allows these devices to be subjected to less regulatory controls if risks are mitigated. The FDA’s class II categorization will enable manufacturers of such devices to go through a less burdensome process of obtaining FDA clearance than would otherwise be the case.
The AI software algorithms for devices provides information to the user about presence, location, and characteristics of areas of the image with clinical implications. That information from such devices is intended to assist the user in determining a pathology diagnosis. To mitigate the identified risk with software algorithm devices, the FDA is applying such as a statement with the device containing a description of situations in which the device may fail or may not operate at its expected performance level (eg, poor image quality or for certain subpopulations).