FDA Mulls Master File Pilot For Makers Of PMA-Approved Devices Sterilized Using Radiation
The US FDA may launch a pilot program that would allow PMA-holders to submit updated master files to the agency if the manufacturers change sterilization methods.
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While half of all medical devices in the US are sterilized with ethylene oxide, emissions from the gas pose potential environmental hazards that are attracting federal action.
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.
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.