The FDA has updated its immediately in effect guidance, Enforcement Policy for Noninvasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
The FDA guidance is aimed at providing a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.
The update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
Read the full guidance document here.
