Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
FDA classifies radiological ML-based quantitative imaging software with a Predetermined Change Control Plan (PCCP) as Class II, subject to special controls.
Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Manufacturers of radiological machine learning-based quantitative imaging software that intend to use a Predetermined Change Control Plan (PCCP) for modifications. should confirm how it applies to their specific situation before acting. There is a time constraint attached: The classification is effective upon publication (June 17, 2026). No specific compliance deadline is stated.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Healthcare AI Regulation (FDA / ONC) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA has classified this device type as Class II (special controls) under 21 CFR 892.2090, establishing a regulatory framework for modifications via PCCP.
Who it affects
Manufacturers of radiological machine learning-based quantitative imaging software that intend to use a Predetermined Change Control Plan (PCCP) for modifications.
What you must do
Review the final classification order and special controls; ensure your device complies with the new classification if you plan to market it or modify it under a PCCP.
Deadline
The classification is effective upon publication (June 17, 2026). No specific compliance deadline is stated.
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