FDA Classifies Computerized Behavioral Therapy Device for Fibromyalgia Symptoms as Class II Medical Device
July 01, 2026
July 01, 2026
WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final rule classifying computerized behavioral therapy devices for treating fibromyalgia symptoms as class II medical devices with special controls.
The rule, effective June 26, 2026, codifies a De Novo classification order that became applicable on May 9, 2023, by adding Section 882.5804 to Title 21 of the Code of Federal Regulations. FDA said the classification . . .
The rule, effective June 26, 2026, codifies a De Novo classification order that became applicable on May 9, 2023, by adding Section 882.5804 to Title 21 of the Code of Federal Regulations. FDA said the classification . . .