Radiation Sterilization Master File Pilot Program FAQ
Q1: What is the Radiation Sterilization Master File Pilot Program? A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, changes to sterilization…