HHS FDA Classifies Adjunctive Pain Measurement Device for Anesthesiology as Class II Device
June 03, 2026
June 03, 2026
WASHINGTON, June 3 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified the adjunctive pain measurement device for anesthesiology into Class II, establishing a regulatory pathway for devices designed to measure a patient's response to painful stimuli while under general anesthesia. The final order, effective June 1, 2026, codifies special controls intended to provide reasonable assurance of safety and effectiveness while supporting access t . . .