USA – FDA launches pilot to speed new ethylene oxide sterilization methods

FDA Monday launched a voluntary pilot to allow companies sterilizing single-use Class III devices in a fixed chamber to submit a master file when making changes to reduce ethylene oxide concentrations or changing sterilization sites. The goal is to allow manufacturers affected by these changes to reference the sterilizer’s master file in a post approval report instead of submitting a premarket approval application supplement. The pilot is intended to speed adoption of new methods to sterilize devices with less ethylene oxide by several months…