1. Medtech Insight

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

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Some medtech manufacturers could get their products approved sooner for sterilization using different ethylene oxide (EtO) plants and/or less ethylene oxide if the sterilizing company they use participates in a new pilot project.

On 25 November, the US Food and Drug Administration announced it is looking for volunteers to participate in its Master File Pilot Program, which is also called the EtO pilot...

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