Federal Register #2026-10675

FDA Classifies Transcutaneous Electrical Nerve Stimulator for Fibromyalgia as Class II Device

This summary covers the FDA's final order classifying a medical device for fibromyalgia treatment: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors: - NeuroMetrix, Inc. (requester for De Novo classification of Quell-FM device) - Products/Services Requested: - Transcutaneous electrical nerve stimulator for fibromyalgia symptoms - Part number: 882.5888 - Prescription device that stimulates sensory nerves via skin electrodes - No specific purchase quantities or procurement action; this is a device classification - Unique or Notable Requirements: - Device is classified as Class II with special controls - Must meet requirements for: - Non-clinical performance testing - Biocompatibility evaluation - Electrical, mechanical, and thermal safety testing - Electromagnetic compatibility testing - Software verification and validation - Hazard analysis - Detailed labeling (including treatment regimes and device parameters) - Classification intended to ensure safety, effectiveness, and facilitate patient access by reducing regulatory burdens - Not a procurement or award notice; no purchase quantities or contract values provided

Description

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms into class II (special controls). This classification provides reasonable assurance of safety and effectiveness and aims to enhance patient access to innovative devices by reducing regulatory burdens. The device is identified as a prescription device that stimulates sensory nerves through electrodes placed on the skin. Special controls include performance testing, biocompatibility evaluation, safety testing, software validation, and specific labeling requirements.

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