FDA Guidance on Ethylene Oxide Sterilization Facility Changes for Class III Devices

On November 26, the FDA issued guidance entitled, “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” The guidance aims to provide a transitional enforcement discretion policy for manufacturers of certain Class III devices to respond to anticipated changes in ethylene oxide (EtO) sterilization activities.

The guidance helps to prevent or mitigate the potential risk of medical device supply chain disruptions or shortages during the time period in which sterilization facilities are transitioning to comply with new Environmental Protection Agency requirements.

This guidance is being published as part of the FDA’s efforts to mitigate potential impacts on the supply of sterile devices due to potential, actual, or temporary stops or reductions in operations at sterilization facilities that use EtO as a medical device sterilant.