Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan

Document 2026-12166 is a Final Rule published by the Department of Health and Human Services in the Federal Register on June 17, 2026, with an effective date of June 17, 2026. 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. View the original at https://www.federalregister.gov/documents/2026/06/17/2026-12166/medical-devices-radiology-devices-classification-of-the-radiological-machine-learning-based.

No. Document 2026-12166 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.