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FDA Pilot Program to Offer Regulatory Alternatives Amid EtO Crackdown

Article-FDA Pilot Program to Offer Regulatory Alternatives Amid EtO Crackdown

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The program targets specific sterilization providers using gamma radiation or ethylene oxide practices that want to change methods.

The FDA recently announced the opening of its Radiation Sterilization Master File Pilot Program as the medical device industry wrestles with potential radioactive cobalt supply chain issues and considerations for ethylene oxide (EtO) exposure and environmental emissions. The voluntary program will allow nine eligible sterilization providers that target single-use medical devices using gamma radiation or EtO to submit a master file to change methods – including the reduction of gamma radiation dose or use of non-gamma radiation sources like x-ray or electron beam. The master file, which will hold a wealth of information about a sterilization providers participation in the pilot program, would then be considered for use as an alternative to regular procedure when changing sterilization methods. Normally, manufacturers of devices with premarket approval (PMA) must submit a supplement under § 814.39(a) and (e) to change their sterilization facility, process, or method.

To be eligible for the program, participants must be a sterilization provider of a single-use device that is provided sterile, be in good compliance standing with FDA, and have an approved gamma radiation or fixed chamber EtO sterilization process for the device in an existing PMA.

Additionally, participants must be proposing one of two changes. One of the two is a change from “a gamma radiation sterilization process at an existing PMA-approved sterilization site to the same gamma radiation process at a different site for the same sterilization provider,” according to the pilot document. Additionally, the other change proposed is from a gamma radiation process at an existing PMA-approved site to an x-ray or electron beam radiation process at the same or different site for the same sterilization provider.

Once a provider determines eligibility, they must submit specific information in a master file for consideration by FDA for participation. Examples of information needed includes:

  • “A complete description of the proposed sterilization cycle(s) including radiation type, target dose, dose range, sterilization load geometry relative to the radiation source.”
  • “A risk analysis with identified risk mitigation measures to address any risks that may impact the PMA approved device’s product parameters or safety and effectiveness profile. This should also include an analysis of material compatibility considerations and how risks related to material compatibility are mitigated.”
  • “Identification and explanation of common potential protocol deviations, along with proposed mitigation of potential deviations. The Master File should also include a strategy to address any deviations that could significantly affect the safety or effectiveness of a device and any deviations not addressed in the Master File.”
  • “A description of how the change from EO sterilization to radiation sterilization is validated to not negatively impact device performance or specifications.”

If accepted into the program, the master file holder then must submit amendments every six months with updates on any process changes, new devices, or PMA submissions brought into the pilot, as well as any other changes to the information contained in the file. If there are no updates or changes, the master file holder is to notify FDA.

“If a sterilization provider is accepted into the pilot program and does not maintain participation (e.g., through non-submission of amendments, updates, or other information requested by FDA under the pilot program or through no longer meeting the eligibility criteria) or no longer wishes to participate in the pilot program, the sterilization provider should notify PMA holders to whom they granted a right of reference to the master file,” according to the program. “If the master file holder does not maintain participation in the pilot program, FDA may determine that the master file is outside the scope of the pilot program.”

The program is currently only directed toward PMA-approved products, excluding medical devices cleared under the 510(k) pathway. FDA explained this is because “changes from one established category A method to another established category A method, including a change from gamma to another radiation source, would generally not need a new 510(k).” Additionally, a new 510(k) would be unnecessary if the change doesn’t significantly affect the performance and biocompatibility or modify the intended use of the device.

A pilot program specifically for 510(k) holders is currently underway to help companies move away from EtO if other ways to sterilize devices are possible. If certain pilot program conditions are met, participants are able to reference the master file to make the change instead of submitting a new 510(k).

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