Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
The FDA has issued a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance outlines the agency’s policy regarding sterilization site changes for Class III medical devices sterilized using ethylene oxide (EtO). It is intended to address potential or actual disruptions at sterilization facilities that may […]
