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

 
• By Shawn M. Schmitt

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.

FDA building.
• Source: Shutterstock

Makers of single-use 510(k) medical devices that use ethylene oxide (EtO) to sterilize already-marketed products would be able to switch their method of sterilization with greater ease thanks to a new pilot program announced by the US Food and Drug Administration on 19 May.

Under the voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send the FDA updated...

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