The U.S. FDA says it is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation sterilization, including gamma radiation.
The FDA is considering this pilot program 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 FDA 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.
The FDA developed the Sterilization Master File Pilot Programs to help ensure patients have access to safe medical devices and encourage new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on public health.
However, this pilot program would not include 510(k)-cleared devices. For 510(k)-cleared devices, radiation is an established category A sterilization method per the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. Per the 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, the FDA says.
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods, like chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.