FDA COVID-Era Policy Guidance for Clinical Electronic Thermometers Made Permanent

In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health emergency.

The FDA first issued the guidance in April 2020 to provide a policy to help expand the availability of clinical electronic thermometers to address the COVID-19 public health emergency. Clinical electronic thermometers are used to measure and monitor body temperature without contact. These devices are an important screening and diagnostic tool to assist in the identification of individuals who have or may have a range of conditions and illnesses and were widely used during the pandemic.

The guidance, “Enforcement Policy for Clinical Electronic Thermometers,” replaces the April 2020 guidance “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

The FDA is also proposing to exempt certain clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements.

Read the full guidance here.

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