21 CFR § 880.2900 - Clinical color change thermometer.
---
identifier: "/us/cfr/t21/s880.2900"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.2900 - Clinical color change thermometer."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.2900"
section_name: "Clinical color change thermometer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---
# 880.2900 Clinical color change thermometer.
(a) *Identification.* A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals.
(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001]