FDA Mulls 510(k) Sterilization Master File
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices. The existing pilot program, which is limited to PMA devices, is intended to streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities. It was established to encourage new, innovative device sterilization methods that reduce the potential impact of EtO on the environment and public health.
According to the agency, adding a 510(k) Sterilization Change Master File Pilot Program would:
- Allow contract sterilizers or 510(k) holders with an established Category B or novel sterilization method to submit a master file. This is further described in the guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Enable other device manufacturers to reference master files to facilitate changes to a cleared medical device’s sterilization method from a fixed chamber EtO sterilization cycle to the sterilization method described in the master file.