Q1: What is the Radiation Sterilization Master File Pilot Program?

A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide (EO) to submit Master File(s) 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.

Also under this program, single-use medical devices using EO may submit a Master File when changing from ethylene oxide sterilization method to an X-ray or E-beam based sterilization method.

STERIS Applied Sterilization Technologies (AST) is excited to participate in this program as it supports our Customers in reducing the amount of ethylene oxide necessary to sterilize medical devices, as well as providing redundancy in processing locations and chambers.

Q2: What is a Device Master File (MAF)?

A: A Device Master File (MAF) provides proprietary data about a material, component, or a manufacturing process (i.e., sterilization) that the holder of the MAF (i.e., STERIS AST) 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 MAF during evaluation of the Customers pre-market approval (PMA), investigational device exemption application (IDE), 510(k) or post-market PMA supplements, 30-day notices, etc.

In addition to Class III medical devices marketed for use in the United States under a PMA subject of the Radiation Master File Pilot Program, all medical devices are eligible to leverage STERIS AST’s MAF in support of their FDA regulatory submissions.

Q3: What are the benefits of utilizing the FDA’s Pilot Program?

A: In addition to accessing the validation services of our Radiation TechTeam, Customers with eligible medical devices will have the benefit of leveraging our 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.

Q4: What if I don’t currently have an active validation for my eligible medical devices at a STERIS AST facility?

A: If you do not currently process or do not have an active validation for the eligible medical device(s) at a STERIS AST facility and intend to transfer these medical devices to processing at STERIS AST, or establish STERIS AST as an alternate sterilization provider, these products are not immediately eligible under the Pilot Program.

To become eligible under the Pilot Program, the Customer must submit a site change PMA supplement that identifies STERIS AST as the new, or alternate, sterilization provider. Once the site change PMA is approved by the FDA, the Customer’s medical device(s) become eligible for participation under the Pilot Program.

Q5: Is the Radiation Master File validation different from previous validations?

A: No. The validations conducted by the Radiation TechTeam subject of the Pilot Program, as with all validations conducted by our Radiation TechTeam, are in compliance with the requirements of ISO 11137 –1 Sterilization of health care products Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Q6: Can I use my company’s own process and protocol for the validation and reference STERIS AST’s Radiation Master File?

A: No. Customer-designed validations whereby the Customer supplies their own protocol and report, and the validation is executed by the respective STERIS AST processing facility are not considered part of the Pilot Program, until or unless their process is revalidated utilizing STERIS AST process qualification in accordance with our internal work instructions and executed by our Radiation TechTeam.

Submission under the Pilot Program represent that the Customer’s validation was executed under a protocol and process accepted by the FDA under this pilot program.

Q7: What medical devices are eligible under the FDA’s Pilot Program?

A: FDA regulated medical devices categorized as Class III, marketed under a Premarket Approval (PMA) that have been validated at STERIS are eligible under the Pilot Program.

In addition to Class III medical devices marketed for use in the United States under a PMA, subject of the Pilot Program, all medical devices validated at STERIS are eligible to leverage STERIS AST’s Device Master File in support of their FDA regulatory submissions.

Q8: What medical devices are not eligible under the FDA’s Pilot Program?

A: The following are not eligible under the Pilot Program:

FDA regulated medical devices not categorized as Class III/not marketed under a Premarket Approval (PMA), reusable devices, reprocessed single-use devices, or devices that are provided non-sterile.

Devices that do not have an approved gamma or fixed chamber EO sterilization process at STERIS AST for the device in an existing PMA.

Changes in contract sterilization providers or addition of a new sterilization provider not approved in an existing PMA.

Devices regulated by CBER, devices with alternate sterility assurance levels other than 10-6 or those with specialized requirements for biocompatibility, sterilant residual compatibility, combination products, and changes to device design, specifications or materials are also not eligible for the Pilot Program.

Our Regulatory Affairs Department can assist in making the determination if your medical devices are eligible for the Pilot Program.

Q9: What actions are necessary to implement a sterilization process change under the pilot program?

A: Upon completion of the validation, the Customer will be requested to submit a Letter of Intent (LOI) to STERIS AST that includes an attestation that all risk mitigation activities related to the change in sterilization have been completed (i.e., evaluation that the change will not impact the device specifications, device performance, biocompatibility, toxicology, etc.). This LOI signifies the Customer is ready to proceed with initiating use of the STERIS AST Master File for the indicated device(s). STERIS AST will then issue a Letter of Authorization (LoA) to the device manufacturer and will provide a copy to FDA.

Once this letter is electronically delivered to the Customer, STERIS AST will add the device to our Master File and the device manufacturer may now use the validated, master file compliant modality and/or processing redundancy.

Q10: How can Customers coordinate with STERIS to take advantage of the Pilot Program?

A: Customers should contact their STERIS AST Account Manager to request that a device/validation be subject under the Radiation Sterilization Master File Pilot Program.

The STERIS Regulatory Affairs Department will then confirm eligibility of the device.

Once the device is confirmed to meet the requirements, and the letter of intent provided, the validation will be completed by the Radiation TechTeam in accordance with the protocol on file within the STERIS AST Device Master File. The final Letter of Authorization will then be provided, and the new specifications implemented.

Q11: Who should I contact for more information on the Radiation Master File Pilot Program?

A: Please send any inquiries via email to ast_masterfile@steris.com.

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