STERIS accepted as first contract sterilizer to participate in the FDA ethylene oxide sterilization master file pilot program

• Innovative FDA program reduces regulatory burden
• Further accelerates shift to Sustainable EO^® sterilization services, reducing use of ethylene oxide

STERIS is pleased to announce that it has been accepted to participate in the U.S. Food and Drug Administration (FDA) Ethylene Oxide Sterilization Master File Pilot Program (Pilot Program), first announced by the FDA in 2019.  At that time, the FDA issued a statement on its efforts to advance innovation in medical device sterilization with ethylene oxide (EO) and reduce the threat of shortages of EO-sterilized medical devices, which represent approximately half of all single-use medical devices requiring sterilization. In addition to next steps regarding the Agency’s EO innovation challenges, the statement introduced the Ethylene Oxide Sterilization Master File Pilot Program (“Pilot Program”).

“The FDA’s Pilot Program aligns with the STERIS MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD and we are excited to be the first contract sterilization provider accepted into the program,” comments Ken Kohler, vice president and general manager, Americas. “The Pilot Program supports our efforts to reduce the amount of ethylene oxide used through our Sustainable EO initiative, while also providing much needed processing redundancy for our Customers in both alternate processing locations and/or sterilization chambers.”

The FDA’s Pilot Program aims to reduce regulatory burden for manufacturers of Class III medical devices, marketed under a Premarket Approval (PMA) by expediting approvals of certain changes to ethylene oxide sterilization cycles and processing facilities via two components:

• Changes from a conventional EO cycle at an existing PMA-approved sterilization site to a reduced/optimized EO concentration cycle at the same or different sterilization site (including chamber changes within the same sterilization site) with the same sterilization provider.

• Changes from a conventional EO cycle at an existing PMA-approved sterilization site to a conventional EO cycle at a different site (or different chamber within the same sterilization site) with the same sterilization provider.

Go here to view the full list of changes outside the scope of the Pilot Program.

Manufacturers and sponsors of Class III medical devices marketed for use in the United States under a PMA making any of the changes described above at a sterilization facility participating in the Pilot Program can reference the Master File submitted by their sterilization provider in a Letter of Intent/Letter of Authorization, rather than a PMA supplement.

STERIS will be hosting an educational webinar on the FDA’s Pilot Program, providing an overview of the initiative, its impact on our Customers, device eligibility and process. Go here to register for the webinar, which will be held on Thursday, December 2 at 11:30am EDT.

For more information regarding the program, please go here to view our frequently asked questions.