EO Sterilization Master File Pilot Program Launched by FDA

Through the ongoing EO Sterilization Master File Pilot Program, the US Food and Drug Administration continues to help medical device manufacturers and contract sterilizers navigate the changing landscape of ethylene oxide (EO) sterilization. The program aims to ensure the availability of safe medical devices and to encourage innovations that reduce the EO-related risks to the public. To date, the FDA has accepted the Master files from Becton, Dickinson and Co., and Boston Scientific.

In 2019, the voluntary pilot program was launched to expedite FDA approval of changes to the EO sterilization. The program also enables companies using fixed-chamber technology to sterilize single-use medical devices to submit a Master File to the FDA. This can be possible if specific changes are made to the processes with reduced EO sterilizations.

The company’s regulatory program holding the EO Master File and for any device manufacturer will be streamlined. The burden is reduced for the file holder’s regulatory submission. Annually, reports of the changes related to reducing EO in its sterilization processes are reported to the FDA.

The Class III device manufacturers are subject to premarket approval may refer to the Master File submitted by their sterilization provider. It will be shown in a post-approval report to the FDA rather than submitting a PMA supplement describing the EO sterilization changes. The agency defines PMA as “the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.” Also, medical devices, including a drug, are not eligible for the EO Sterilization Master File Pilot Program.