FDA Issues Transitional EtO Enforcement Policy

The FDA issued “Transitional Enforcement Policy for Ethylene Oxide (EtO) Sterilization Facility Changes for Class III Devices” to respond to anticipated changes in EtO sterilization activities as facilities work to advance orderly implementation of and compliance with EPA’s 2024 rule which revised emissions standards for EtO. This guidance is intended to prevent or mitigate the potential risk of supply chain disruptions or medical device shortages during the time period in which manufacturers are transitioning to compliance with new requirements. Read the FDA guidance.