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.