FDA Allows 1st Master File Use for Sterilizer

FDA says it has accepted the first master file for participation in the 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. Under the program, 510(k) holders of devices labeled as sterile that want to begin using Andersen Sterilizers EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized Class 1 or Class 2 devices may reference the master file rather than submitting a new 510(k) for the sterilization change. “Andersen Sterilizers sterilization system uses a customizable small chamber, which requires less EO than established EO systems, supporting the agency’s goal of minimizing the use of EO,” the agency says.

For more information, see this FDA Web page on Master Files and this guidance entitled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.”