STERIS to participate in FDA Radiation Sterilization Master File Pilot Program

STERIS AST, a member of iia, has announced that it is the first contract sterilizer to be accepted to participate in the US FDA Radiation Sterilization Master File Pilot Program.  This voluntary program intends to allow companies that sterilize single-use medical devices using gamma irradiation or ethylene oxide (EO) to submit Master Files when making certain changes to sterilization sites, changes to sterilization methods to utilize non-gamma radiation sources (i.e., X-ray or electron beam), or changes to sterilization processes to utilize reduced gamma radiation doses.  Master Files provide proprietary data about a material, component, or a manufacturing process (i.e. sterilization) that the holder wishes to make available to FDA on behalf of their customers, in support of their device-related submissions to FDA.  In turn, FDA references the content of the Master Files during evaluation of the customers pre-market approval (PMA), investigational device exemption application, 510(k) or post-market PMA supplements, 30-day notices, etc.  The benefit is that customers with eligible medical devices will have the benefit of leveraging the Radiation Master File as an alternate mechanism for adding processing redundancy or converting to a radiation sterilization process in lieu of submitting a 180-day site change supplement or a 30-day change notice to the FDA respectively.

STERIS will host a webinar providing an overview of the Radiation Sterilization Master File Pilot Program initiative and its impact on 30th November 2023.  Registration for this webinar is possible via this link: Registration (

For further information, please read the STERIS press release and their FAQ document.

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