21 CFR 880.2910
Clinical electronic thermometer
21 CFR 880.2910 is the regulation titled “Clinical electronic thermometer” in 21 CFR Part 880, General Hospital and Personal Use Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 880.2910 (eCFR, as of Sep 1, 2026)
(a) Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
(b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:
(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
[45 FR 69682, Oct. 21, 1980, as amended at 90 FR 25891, June 18, 2025]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 880.2910.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 801.40Form of a unique device identifier1 letter cites both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.20How do I complete and submit an individual adverse event report?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1 letter cites both
Latest letters citing it
The letter citing 21 CFR 880.2910 that FDA posted most recently.
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