 
Today, the U.S. Food and Drug Administration (FDA) issued a final guidance, which takes effect immediately, titled: Enforcement Policy for Clinical Electronic Thermometers.
Clinical electronic thermometers are used to measure and monitor the body temperature of patients. 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 or illnesses.
This guidance:
- Describes enforcement policies regarding certain legal requirements for clinical electronic thermometers, including those with and without telethermography or continuous temperature measurement functions.
- Identifies scenarios under which these devices generally will not create an undue risk when certain performance and labeling elements such as those described in the guidance are incorporated.
This document supersedes “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” issued in April 2020.
In conjunction with the issuance of this guidance, the FDA is proposing to exempt certain clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements. The FDA intends to withdraw this Enforcement Policy guidance after any final exemption notice has been published in the Federal Register.
This guidance document is being implemented immediately. Stakeholders can still submit comments on this guidance in accordance with the FDA’s good guidance practices to https://www.regulations.gov as described in the guidance.
Questions?
If you have questions about this guidance, contact the Division of Industry and Consumer Education.
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