Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
FDA classifies computerized behavioral therapy device for fibromyalgia as a medical device, not a cosmetic. No direct impact on MoCRA-regulated cosmetics businesses.
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) regulated under MoCRA. 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 classification order for a computerized behavioral therapy device for fibromyalgia symptoms, placing it under medical device regulations. This does not affect cosmetics or personal care products.
Who it affects
Cosmetics and personal care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) regulated under MoCRA.
What you must do
No action required for cosmetics businesses. Continue compliance with MoCRA requirements.
Deadline
N/A
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