FDA Issues New Policy on Clinical Electronic Thermometers During COVID-19

Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of some clinical electronic thermometers with certain performance and labeling elements to be distributed and used without meeting a number of specific regulatory requirements. These devices include both contact and non-contact clinical electronic thermometers.  This policy reflects the FDA’s commitment to providing timely guidance that may help address public health concerns by helping to expand the availability of clinical electronic thermometers during this public health emergency.

Read the Guidance This guidance is intended to complement the March 2020 guidance Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. Questions? If you have questions about this guidance, contact CDRH-COVID19-Thermometers@fda.hhs.gov.