Alert detail
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
What changed
Final Rule published 2026-05-29. The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat 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 transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. We are taki
Who’s affected: Multi-specialty billing teams · Effective: May 29, 2026
Primary source: View the official CMS/MAC document ↗
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