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FDA Launches Pilot For Makers Of Single-Use 510(k) Devices To Encourage Sterilization Switch

Executive Summary

Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.

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