> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDRH Device Sterility Master File Pilot
- URL: https://www.fdaweb.com/cdrh-device-sterility-master-file-pilot/
- Published: 2022-05-19T12:00:00.000Z
- Updated: 2026-09-14T17:45:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151849

CDRH has announced a new “510(k) Sterility Change Master File Pilot Program” that is intended to give interested companies that terminally sterilize single-use devices (sterilization providers) using certain sterilization methods a pathway to submit a master file for the Center’s review. “FDA will accept a master file into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the master file could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the master file and that satisfies other conditions outlined in this document,” an [agency notice](https://public-inspection.federalregister.gov/2022-10925.pdf?ref=fdaweb.com) says.  

[Under the program](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery), if a master file is accepted, device makers may choose to reference it in internal documentation to support justification for not submitting a new 510(k) under certain conditions. “This voluntary pilot program seeks to encourage industry to consider new, innovative ways to sterilize devices that reduce the potential impact of EtO on the environment and on public health, while ensuring consistent patient access to safe devices and providing a framework for future regulatory approaches that would help address potential device shortages related to EtO sterilization,” the notice explains.

FDA says about 50% of all sterile devices in the U.S. are sterilized using EtO. Environmental and exposure concerns have led to the closure of some device sterilization facilities. “Future losses of sterilization capacity due to facility closure have the potential to result in shortages of sterile devices if an alternative for sterilization is not readily available for the devices sterilized at a closed facility,” it says.