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 Class II (special controls), effective June 26, 2026.
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 computerized behavioral therapy devices for fibromyalgia symptoms, including health tech startups and medical device companies. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Immediately for new devices; existing devices must comply with special controls by the effective date.. 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
The device is now classified as Class II (special controls) under 21 CFR 882.5891, requiring premarket notification (510(k)) and compliance with special controls (e.g., clinical performance testing, software verification, labeling).
Who it affects
Manufacturers of computerized behavioral therapy devices for fibromyalgia symptoms, including health tech startups and medical device companies.
What you must do
Submit a 510(k) premarket notification for any device not already legally marketed before June 26, 2026, and ensure compliance with special controls.
Deadline
Immediately for new devices; existing devices must comply with special controls by the effective date.
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