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# Clinical e-Thermometer Enforcement Policy
- URL: https://www.fdaweb.com/clinical-e-thermometer-enforcement-policy/
- Published: 2023-11-02T12:00:00.000Z
- Updated: 2026-09-14T14:15:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155706

FDA has issued a [final guidance](https://www.fda.gov/media/136698/download?ref=fdaweb.com) entitled “Enforcement Policy for Clinical Electronic Thermometers.” The agency describes clinical electronic thermometers as devices used to measure and monitor the body temperature of patients as an important screening and diagnostic tool to assist in identifying those who have a range of conditions or illnesses. The document is intended to:

- Describe enforcement policies on certain legal requirements for clinical electronic thermometers, including those with and without telethermography or continuous temperature measurement functions.
- Identify scenarios where such devices generally will not create an undue risk when certain performance and labeling elements described in the guidance are incorporated.

Additionally, FDA notes that it is proposing to exempt certain clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements. The agency intends to withdraw this enforcement policy guidance after the final exemption notice has been published in the *Federal Register*.