HHS FDA Classifies Ultrasound Anatomy Labeling Device for Regional Anesthesia as Class II Medical Device
June 04, 2026
June 04, 2026
WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying a real-time ultrasound anatomy visualization and labeling device used in ultrasound-guided regional anesthesia as a Class II medical device with special controls. The action, effective June 1, 2026, codifies regulatory requirements for the device and establishes safety and performance standards that manufacturers must meet before marketing similar produ . . .