Introduction to the Ethylene Oxide Master File Pilot Program
STERIS is pleased to be the first contract sterilizer to participate in the FDA’s Ethylene Oxide Sterilization Master File Pilot Program.
During this TechTalk, STERIS experts give an overview of the pilot program, including program eligibility and implementation.
Contract SterilizationEthylene OxideGas ProcessingMicrobiological TestingTesting & Validation
The FDA created the ethylene oxide sterilization pilot program to provide a streamlined regulatory process and reduce the regulatory burden for manufacturers of Class III medical devices, allowing them to make modifications without the need to submit PMA supplements.
Read the full announcement from STERIS AST
Want to learn more? Explore the EO Master File Pilot Program FAQ