Federal Register #2026-12901

FDA Classifies Computerized Behavioral Therapy Device for Fibromyalgia as Class II Medical Device

This FDA final order establishes regulatory requirements for computerized behavioral therapy devices intended to treat fibromyalgia symptoms. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - No specific OEMs or vendors are named in this notice - Products/Services Requested: - Computerized behavioral therapy device for fibromyalgia (no part numbers or quantities specified) - Device must provide a computerized version of behavioral therapy for prescription use - Unique or Notable Requirements: - Device classified as a Class II medical device with special controls - Requires clinical data demonstrating device performance and effectiveness - Software verification and validation are mandatory - Physician and patient labeling must include treatment regimens and clinical data summaries - Subject to premarket notification (510(k)) requirements - Demonstration of safety and effectiveness is required - This is a regulatory classification action, not a procurement or contract opportunity.

Description

The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms into class II with special controls. This classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. The device is a prescription device intended to provide a computerized version of behavioral therapy for fibromyalgia symptoms. Special controls include clinical data demonstrating device performance, software verification and validation, and specific physician and patient labeling requirements.

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