The U.S. FDA reported March 20 its first Master File acceptance into the FDA Ethylene Oxide Sterilization Master File Pilot Program (EtO Pilot Program). The agency hopes the EtO Pilot Program leads to sterilization facilities using a greatly reduced amount of ethylene oxide while still providing robust patient safeguards. The agency unveiled the voluntary program last November. It is intended to allow sterilization providers that sterilize single-use medical devices using fixed-chamber EtO to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations.
The U.S. FDA reported initiatives March 20 related to COVID-19. For one, it unveiled final guidance, titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The agency said it was issuing the guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate patient monitoring during the COVID-19 pandemic. The policy is intended to remain in effect only for the duration of the public health emergency. The agency also said it is holding a virtual town hall March 25, between 3 p.m. and 4 p.m. ET, for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2. The goal is to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the FDA’s updated policy on COVID-19 Diagnostics that came out March 16. The FDA has provided a list of dates for future virtual town halls.