Medical Devices
On November 25, 2019, the FDA provided updates on its efforts to address the need for innovation and improvements to medical device sterilization techniques. Innovation Challenges: The FDA selected 11 participants to work directly with the FDA to accelerate the development and review of sterilization technology innovations.
Ethylene Oxide Sterilization Master File Pilot Program: The FDA announced a new, voluntary pilot program intended to streamline the processes for sterilization providers and device manufacturers to make certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations.