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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...

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