CDRH Unveils Pilot Project for Sterilization Changes

As medical device ethylene oxide (EtO) sterilization facilities continue to close across the country, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Monday unveiled a new pilot project to expedite certain changes to EtO sterilization processes and facilities.

The voluntary pilot will allow manufacturers of Class III devices to reference a Master File submitted by up to nine sterilization providers in lieu of submitting a premarket approval application (PMA) supplement.

“Under this pilot program, sterilization providers that sterilize single-use medical devices using fixed chamber EtO would submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, PMA holders of Class III devices affected by such changes may, upon FDA’s permission, reference the Master File submitted by their sterilization provider in a postapproval report,” the agency said…