The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the radiological machine learning-based quantitative imaging software with predetermined change control plan. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 17, 2026
FDA Classification of Radiological Machine Learning-Based Quantitative Imaging Software as Class II Medical Device
Original title: Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
FDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plan as Class II, establishing special controls for this device category.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.