# 2026-12901: FDA Downgrades Fibromyalgia Therapy Device to Class II 2026-12901, Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-26, effective 2026-06-26; PRIA reads it as touching household money (as of 2026-07-03). - Canonical: https://policyrisk.com/federal-register/2026-12901 - As of: 2026-07-03 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-12901 - Title: Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms - Type: Rule - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 38510 - Published: 2026-06-26 - Effective: 2026-06-26 - Comments close: not stated - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-07-03 ## In one line FDA Downgrades Fibromyalgia Therapy Device to Class II ## Summary The FDA is officially classifying a computerized behavioral therapy device for fibromyalgia symptoms as a Class II device, meaning it meets safety and effectiveness standards with special controls. This change helps patients get easier access to this innovative treatment by reducing some regulatory hurdles. The new classification is effective June 26, 2026, and could speed up how quickly these devices reach the market without extra costs. ## Abstract The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms 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 computerized behavioral therapy device for the treatment of fibromyalgia symptoms. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. ## Effects PRIA read - Device Reclassified to Class II — Easier Access: benefit, medium. The FDA officially classified the computerized behavioral therapy device for treatment of fibromyalgia symptoms as Class II with special controls, effective June 26, 2026 (classification applicable May 9, 2023). The FDA says this classification will provide reasonable assurance of safety and effect… - Prescription-Only Requirement Maintained: cost, low. At the time of classification, the computerized behavioral therapy device for fibromyalgia symptoms is a prescription device intended to provide a computerized version of behavioral therapy. Prescription devices remain subject to prescription-only conditions and related labeling rules. - 510(k) Premarket Notification Is Required: cost, medium. FDA states that computerized behavioral therapy devices for fibromyalgia symptoms are subject to premarket notification requirements under section 510(k) of the FD&C Act (they have not been exempted under section 510(m)). Manufacturers must therefore submit a 510(k) to market these Class II devices. - New Special Controls: Clinical Data, Software, Labeling: mixed, medium. FDA set special controls for this device type: clinical data must evaluate improvement in fibromyalgia symptoms and relevant adverse events; software verification, validation, and hazard analysis are required; and physician and patient labeling must include recommended treatment regimes (frequency… - Sets Predicate for Future Devices — Easier 510(k) Route: benefit, medium. FDA states that when a device is classified into class II through the De Novo process, that device can serve as a predicate for future devices of that type, allowing other sponsors to use the less burdensome 510(k) process instead of a De Novo or PMA. This can reduce regulatory burdens for future d… ## Related documents - [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13 - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 ## Sources - [2026-12901 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/26/2026-12901/medical-devices-neurological-devices-classification-of-the-computerized-behavioral-therapy-device) - [2026-12901 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12901.pdf) ## Related - [Previous: 2026-12900, Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of t…](https://policyrisk.com/federal-register/2026-12900) - [Next: 2026-12902, Medical Devices; Immunology and Microbiology Devices; Classification of the SAR…](https://policyrisk.com/federal-register/2026-12902) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-12901 (as of 2026-07-03).