CDRH Announces Pilot Program for Device Sterilizers

November 25, 2019

The FDA is launching a master file pilot program for sterilization providers that conduct ethylene oxide (EtO) sterilization, a technique used to sterilize an estimated 50 percent of all medical devices in the U.S.

The voluntary pilot program allows companies that sterilize single-use medical devices using the technique to submit a master file when they make certain changes between sterilization facilities or to sterilization processes that use reduced EtO concentrations.

Premarket application holders of Class III devices subject to approval that are impacted by the  changes may request the agency’s permission to reference the master file submitted by their sterilization provider in a post-approval report rather than submit a PMA supplement.

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