HHS FDA Classifies Fibromyalgia Nerve Stimulator Device Into Class II Category
June 02, 2026
June 02, 2026
WASHINGTON, June 2 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying a transcutaneous electrical nerve stimulator designed to treat fibromyalgia symptoms into the agency's class II medical device category with special controls, a move the agency said will provide reasonable assurance of safety and effectiveness while reducing regulatory burdens for manufacturers.
The order, effective May 29, 2026, codif . . .
The order, effective May 29, 2026, codif . . .