Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.882.5700 Thermal system for insomnia

Current as of October 02, 2022 | Updated by FindLaw Staff

(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.

Back to chapter list
Previous part of code Next part of code
Back to chapter list

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.882.5700 Thermal system for insomnia - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-882-5700/

Read this complete Code of Federal Regulations Title 21. Food and Drugs § 21.882.5700 Thermal system for insomnia on Westlaw

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.

Was this helpful?

Search all Codes

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw's Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About the Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to find an attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

    More Options
    Copied to clipboard