Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.882.5801 Computerized behavioral therapy device for psychiatric disorders

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical data must be provided to fulfill the following:

(i) Describe a validated model of behavioral therapy for the psychiatric disorder;  and

(ii) Validate the model of behavioral therapy as implemented by the device.

(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.

(3) The following labeling must be provided:

(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.

(ii) Patient and physician labeling must list compatible devices.

(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.

(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.

(v) Physician labeling must include a summary of the clinical testing with the device.

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 § 21.882.5801 Computerized behavioral therapy device for psychiatric disorders - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-882-5801/

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 before relying on it for your legal needs.

Was this helpful?

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)

Copied to clipboard