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FDA Issues Radiation Sterilization Update for PMA Holders

The agency is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.

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The following is an edited version of the original release.

On June 7, the FDA announced it is considering a master file pilot program for premarket approval holders due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.

The agency is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices, including using lower levels of currently used sterilizing agents and using new sterilizing agents or alternatives, while maintaining device safety and effectiveness.

This pilot program would not include 510(k)-cleared devices, for which radiation is an established category A sterilization method. Per “Deciding When to Submit a 510(k) for a Change to an Existing Device,” 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) if the change could not significantly affect the performance or biocompatibility of the device, or constitute a major change or modification in the intended use of the device.

In May, the FDA announced a Sterility Change Master File Pilot Program for sterilization changes to 510(k)-cleared medical devices for sterilization providers with an Established Category B or Novel Sterilization Method, intended to help with changes to a cleared medical device’s sterilization method from a fixed chamber EtO sterilization cycle to the sterilization method described in the Master File.

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