HHS FDA Establishes Class II Category for Sterilization Containers With Electronic Monitoring
June 04, 2026
June 04, 2026
WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Administration Food and Drug Administration has issued a final order classifying rigid sterilization containers with electronic monitoring as Class II medical devices subject to special controls. The action takes effect June 1, 2026, and codifies a classification that first became applicable on June 17, 2022. FDA said the classification provides reasonable assurance of safety and effectiveness while supporting patient access t . . .
