FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF THE RADIOLOGICAL MACHINE LEARNING-BASED QUANTITATIVE IMAGING SOFTWARE WITH PREDETERMINED CHANGE CONTROL PLAN

WASHINGTON, June 17 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan.

The rule was published in the Federal Register on June 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 ra...