COVID-19 Update: FDA’s Updated Policy for Non-Invasive Remote Monitoring Devices

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during?utm_campaign=2020-06-05%20COVID-19%20Remote%20Monitoring%20Updated%20Guidance&utm_medium=email&utm_source=Eloqua

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) issued an immediately in effect guidance to expand the availability and capability of non-invasive 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.  This guidance replaces the "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency" issued on March 20, 2020. This version expands the scope of the guidance to include additional device types (product codes) and provides additional references and standards for consideration. The FDA is committed to providing timely guidance to support response efforts to this pandemic.

Read the Guidance Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.