The U.S. Food and Drug Administration (FDA) has developed the Sterilization Master File Pilot Programs (Pilot Programs) to help ensure patients have access to safe medical devices and encourage new, innovative ways to sterilize medical devices.
STERIS has been accepted into both the Radiation Sterilization Master File Pilot Program and the Ethylene Oxide Sterilization Master File Pilot Program. The Pilot Programs support STERIS’s efforts to provide sterilization supply chain resiliency through a technology-neutral processing option that utilizes both radiation and gas technologies.
Both the EO and Radiation Pilot allow manufacturers of Class III medical devices, marketed under a premarket approval (PMA), to modify their existing EO or gamma sterilization process with reduced regulatory burden. Eligible participants making any applicable changes at a STERIS facility may be eligible to reference the MAF submitted by STERIS once a letter of authorization is provided by STERIS.
What is the Radiation Sterilization Master File Pilot Program?
The Radiation Sterilization Master File Pilot Program is a voluntary program designed for manufacturersthat terminally sterilize single-use medical devices using radiation or ethylene oxide (EO). This program allows companies to submit Master Files when making certain changes, such as:
- Changing sterilization sites
- Changing sterilization method from one radiation source, such as gamma, to an alternative radiation source, such as X-ray or electron beam
- Changing from ethylene oxide sterilization method to a radiation sterilization method
- Changing sterilization processes to utilize reduced radiation doses
What is the Ethylene Oxide (EO) Sterilization Master File Pilot Program?
The Ethylene Oxide Sterilization Master File Pilot Program allows manufacturers to modify their EO sterilization processes without the need for a PMA supplement for FDA approval, reducing regulatory burden. The Pilot expedites approvals of certain changes to EO sterilization and processing through the following components:
- Changing from a conventional EO cycle to a reduced/optimized EO concentration cycle
- Changing from a conventional EO cycle to a conventional EO cycle at a different site
- Changing a conventional EO cycle to a different chamber within the same sterilization site
What are the benefits of utilizing the FDA’s Sterilization Master File Pilot Programs?
In addition to accessing the validation services of our TechTeam professionals, Customers with eligible medical devices will have the benefit of leveraging our sterilization MAFs as an alternate mechanism for adding processing redundancy or converting their EO or gamma sterilization process in lieu of submitting a 180-day site change supplement or a 30-day change notice to the FDA respectively.
How can I learn more about STERIS’s participation in the FDA’s Sterilization Master File Pilot Programs?
- Radiation Sterilization Master File Pilot Program FAQ
- Learn more about the program in a series of frequently asked questions.
- Ethylene Oxide Master File Pilot Program FAQ
- Learn more about the program in a series of frequently asked questions.
- Introduction to the Radiation Sterilization Master File Pilot Program | STERIS AST TechTalk
- In this TechTalk webinar, learn eligibility requirements, the intricacies of different radiation sterilization modalities, and how STERIS guides Customers throughout the entire process.
- Introduction to the Ethylene Oxide Master File Pilot Program | STERIS AST TechTalk
- During this TechTalk webinar, STERIS Technical Professionals give an overview of the pilot program, including program eligibility and implementation.