This update expands the scope of the guidance to include an additional device type.

If your email program has trouble displaying this email, view as a webpage. FDA Updates Policy on Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During COVID-19 Today, the U.S. Food and Drug Administration (FDA) updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which include capnographs and devices with a capnography feature. Read the Guidance Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.

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