FDA Launches EtO Sterilization Master File Pilot Program
Today FDA announced the launch of the Ethylene Oxide Sterilization Master File Pilot Program. The goal of the voluntary program is to “streamline the submission process, so that sterilization providers that sterilize single-use medical devices using fixed chamber sterilization processes may submit a Master File to the FDA when making certain changes between sterilization sites, or when making certain changes to sterilization processes that utilize reduced ethylene oxide concentrations, and PMA holders can reference such a Master File in a postapproval report instead of submitting a traditional PMA supplement,” according to an FDA news update.
The details of the pilot program will be published on the Federal Register on Tuesday, November 26.
In June FDA announced two Innovation Challenges to find new methods of device sterilization as well as ways to reduce EtO emissions. Out of the 46 applications that the agency received, it selected 12 applicants for participation in the challenges.
Earlier this month the FDA held the General Hospital and Personal Use Devices Panel Advisory Committee Meeting. The meeting minutes are now available on the agency’s website.
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