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FDA Mulls Master File Pilot For Makers Of PMA-Approved Devices Sterilized Using Radiation

 
• By Shawn M. Schmitt

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.

The symbol for radiation.
• Source: Shutterstock

Makers of PMA-approved devices that are sterilized using radiation – including gamma radiation – might be wooed soon by the US Food and Drug Administration for a potential pilot program that would look at alternative ways to sterilize such products.

The pilot under consideration, which hasn’t been given a name, would allow a PMA-holder to submit updated master files to the agency if

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