Ethylene Oxide Master File Pilot Program FAQ
Q: What is the Ethylene Oxide (EO) Sterilization Master File Pilot Program? A: In an effort to advance innovation in medical device sterilization with ethylene oxide (EO) and reduce the threat of shortages of EO-sterilized medical devices by providing a streamlined and flexible regulatory process, FDA introduced the Ethylene Oxide Sterilization Master File Pilot Program…