---
kind: "section"
citation: "21 C.F.R. § 882.5700"
title: "21"
number: "882.5700"
heading: "Thermal system for insomnia."
url: "https://uscodex.org/cfr/21/882.5700"
---

# §882.5700. Thermal system for insomnia.

- (a) **Identification.** A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Performance testing must demonstrate electromagnetic compatibility and electrical safety.
  - (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
    - (i) Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions.
    - (ii) **Mechanical testing to demonstrate the device can withstand forces under anticipated use conditions.**
    - (iii) **Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions.**
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly.

## Notes

### Amendments

[81 FR 44772, July 11, 2016]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[81 FR 44772, July 11, 2016]