The Food and Drug Administration (FDA) has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
Computerized behavioral therapy devices are prescription-only devices that are used as an adjunct to clinician supervised outpatient treatment to provide condition-specific behavioral therapy for various psychiatric conditions (ie, obsessive compulsive disorder, generalized anxiety disorder, insomnia disorder, major depressive disorder, substance use disorder, posttraumatic stress disorder, autism spectrum disorder, attention deficit disorder).
According to the policy, the Agency does not object to the use of these digital health technologies for the duration of the public health emergency as they may help patients with psychiatric conditions improve their mental health and well being, and also facilitate social distancing. Additionally, the FDA is allowing the use of other digital health therapeutic devices, as well as nonprescription devices, that are intended to treat psychiatric disorders and are considered low risk (not intended for use for a psychiatric condition that may require an immediate response such as suicidality).
To help patients better understand these devices, the FDA is recommending that developers include the following information on the labeling:
- A clear statement that a patient should contact their physician before using the device, even if it is marketed to a consumer.
- Additional resource information, such as references to recommendations made by healthcare organizations, as well as instructions on what to do in case of a medical emergency.
- A clear description of the indication for use, including the intended patient population, as well as the recommended duration and frequency of use. The labeling should note that the device should not be used solely for treating the psychiatric condition and is not a substitute for a patient’s medication. In addition, any indications or functions that are not FDA-cleared should be clearly identified.
- A description of the therapeutic method (ie, behavioral therapy, cognitive restructuring) and a summary of clinical testing. There should also be a description of the method of determining any treatment recommendations, as well as instructions on when a patient should consult a healthcare professional. The device should clearly indicate what to do if symptoms are not improving and in what time period improvement should be expected.
- Instructions for use that include images demonstrating how to interact with the device.
The policy will remain in effect for the duration of the COVID-19 public health emergency.
For more information visit fda.gov.