FDA Classifies External Nerve Stimulator for Restless Legs Syndrome as Class II Medical Device With Special Controls
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 external nerve stimulators for Restless Legs Syndrome as class II medical devices with special controls.
The rule, effective June 26, 2026, codifies a De Novo classification order that became applicable on April 17, 2023, by adding Section 882.5887 to Title 21 of the Code of Federal Regulations. FDA said the action provides a reasonable assu . . .
The rule, effective June 26, 2026, codifies a De Novo classification order that became applicable on April 17, 2023, by adding Section 882.5887 to Title 21 of the Code of Federal Regulations. FDA said the action provides a reasonable assu . . .