---
kind: "section"
citation: "21 C.F.R. § 872.5590"
title: "21"
number: "872.5590"
heading: "Intraoral cooling device."
url: "https://uscodex.org/cfr/21/872.5590"
---

# §872.5590. Intraoral cooling device.

- (a) **Identification.** An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients to reduce the likelihood of oral mucositis. The device consists of a removable mouthpiece that cools the oral mucosal surfaces.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
    - (i) Thermal testing to evaluate cooling consistency and performance; and
    - (ii) **Testing of the device to demonstrate material integrity.**
  - (2) Electromagnetic compatibility and electrical safety testing must be performed for any electrical components.
  - (3) Software verification, validation, and hazard analysis must be performed for any software components of the device.
  - (4) The patient contacting components of the device must be demonstrated to be biocompatible.
  - (5) Labeling must include the following:
    - (i) A summary of the device specifications, including temperature cooling range and duration of cooling; and
    - (ii) Instructions to stop the use of the device if skin irritation or sensitivities develop, or if the device leaks or does not maintain its material integrity.

## Notes

### Amendments

[91 FR 32344, June 1, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[91 FR 32344, June 1, 2026]