FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new voluntary pilot program aimed at improving technologies and practices used in the sterilization of medical devices.

According to a press release issued by the FDA’s Center for Devices and Radiological Health (CDRH), the new Radiation Sterilization Master File Pilot Program will be open to nine companies that currently sterilize single-use, PMA-approved medical devices using gamma radiation or ethylene oxide (EtO). Participating companies will submit master files of any changes to their sterilization processes or methods, which can then be referenced by PMA holders in their required post approval reports.

Read the CDRH’s press release about the new Radiation Sterilization Master File Pilot Program.

Additional details about the Pilot Program are available on the FDA’s website.

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