Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
Key claim: The FDA is classifying radiological machine learning-based quantitative imaging software with a predetermined change control plan as Class II medical devices subject to special controls, aiming to ensure safety and effectiveness while reducing regulatory burdens and improving patient access.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
This is the first time FDA has formalized a device classification specifically built around a Predetermined Change Control Plan for AI/ML software, operationalizing a governance mechanism that lets models be updated within pre-authorized bounds rather than re-cleared each time. It sets a template other agencies and device categories may follow for regulating adaptive AI systems, balancing safety oversight with the reality that ML models evolve after deployment.