FDA takes steps to expedite innovation in ethylene oxide sterilization

The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities. Under the pilot program, facilities that use fixed-chamber ethylene oxide sterilization processes to sterilize single-use medical devices would submit a “master file” to the FDA when making certain changes to their location or changes to their sterilization processes that use lower ethylene oxide concentrations. The FDA believes the program will allow more efficient review and feedback, ultimately allowing the agency to provide a more nimble response to site closures in the future. In addition, FDA said it will work with 12 applicants to its innovation challenges to accelerate the development and review of innovative technologies for sterilization processes, and is moving forward with certain recommendations from its recent advisory committee meeting.