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# New FDA Efforts on Device EtO Sterilization
- URL: https://www.fdaweb.com/new-fda-efforts-on-device-eto-sterilization/
- Published: 2019-11-25T12:00:00.000Z
- Updated: 2026-09-14T15:54:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145577

FDA 11/25 announced its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a “master file” when making certain changes between sterilization sites or to sterilization processes that utilize reduced EtO concentrations. “Under this voluntary program, manufacturers (PMA holders) of Class III devices subject to premarket approval that are affected by such changes may reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a PMA supplement,” an [FDA notice](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices?utm%5Fcampaign=2019-11-25%20Updates%20on%20Ethylene%20Oxide%20Sterilization%20of%20Medical%20Devices&utm%5Fmedium=email&utm%5Fsource=Eloqua) says.  

The agency is seeking participation in the pilot, with up to nine eligible firms to be selected. For more information, refer to [*Federal Register* notice FDA-2019-N-5465](https://federalregister.gov/d/2019-25631?ref=fdaweb.com).

Meanwhile, FDA has selected 12 participants for two previously announced public innovation challenges to encourage development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices. Participants selected will work directly with the agency to accelerate the innovative technology’s development and review. More details are found on the following Web pages for each challenge:

- [**Challenge 1: Identify New Sterilization Methods and Technologies**](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies?ref=fdaweb.com)**:** The goal of this challenge is to encourage the development of new approaches to device sterilization methods or technologies for medical devices that do not rely on ethylene oxide.
- [**Challenge 2:** ](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions?ref=fdaweb.com)[**Reduce Ethylene Oxide Emissions**](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions?ref=fdaweb.com)**:** The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.