Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
FDA classifies radiological machine learning-based quantitative imaging software with a predetermined change control plan, but this rule is specific to medical devices and does not directly impact cosmetics or personal care products under MoCRA.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Cosmetics and personal care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) are not affected. should confirm how it applies to their specific situation before acting. There is a time constraint attached: N/A. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) 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 issued a final rule classifying a type of radiology software as a medical device; no changes to cosmetics regulations.
Who it affects
Cosmetics and personal care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) are not affected.
What you must do
No action needed for cosmetics compliance.
Deadline
N/A
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