Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
Updated 4 hours ago ()
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.
- Tags
- information blocking, Rule, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISSP 8: Software Development Security; CISM 3: Information Security Program; CISA 1: Information System Auditing Process; CISA 3: Information Systems Acquisition, Development and Implementation
- Source record id
- 2026-12166
- First seen by InfoSec Signals
- Sep 23, 2026
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