FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19

‍FDA eases entry for psychiatric apps during COVID-19

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FDA is not requiring adherence to premarket applications and other regulations for digital health devices focused on helping treat patients with psychiatric disorders during the COVID-19 public health emergency. The guidance generally applies to:

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1. Computerized Behavioral Therapy devices and other digital health therapeutic devices for psychiatric disorders per 21 CFR 882.5801 and;
2. Low-risk general wellness and digital health products for mental health or psychiatric conditions.

Regulations that won’t apply for such devices: 

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1. Submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81; 
2. Reports of Corrections and Removals requirements in 21 CFR 806; 
3. Registration and Listing requirements in 21 CFR Part 807; 
4. and Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.

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An example of a circumstance where FDA currently believes devices would create such an undue risk includes treatment claims for specific psychiatric conditions where the underlying psychiatric condition may require an urgent or immediate clinical intervention and the delay of the intervention may pose significant harm to the patient, such as treatment of suicidality.

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‍Examples of What is NOT REGULATED under COVID-19

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‍CBT & Digital Therapeutic relevant psychiatric conditions include:

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1. Obsessive Compulsive Disorder
2. Generalized Anxiety Disorder
3. Insomnia Disorder
4. Major Depressive Disorder
5. Substance Use Disorder
6. Post-traumatic Stress Disorder
7. Autism Spectrum Disorder
8. Attention Deficit Hyperactivity Disorder

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Other Digital Health Devices:

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1. promoting relaxation, mindfulness, meditation
2. reducing stress, fatigue, or feelings of isolation due to the COVID-19 public health emergency
3. Promoting good sleep 
4. Improving your sleep experience
5. Having more relaxing or restful sleep
6. Sleeping through the night or sleeping all night
7. General Wellness software functions related to mental health or psychiatric conditions due to the current period of increased public health awareness related to the COVID-19 pandemic
8. General Wellness software functions to promote, track, and/or encourage choices, which, as part of a healthy lifestyle, may help living well with or reduce the risk of certain chronic psychiatric diseases or conditions where the link between living well and reducing the risk or impact of a chronic psychiatric disease or medical condition is well understood
9. Depression
10. Anxiety
11. Obsessive Compulsive Disorder
12. Autism 
13. Attention Deficit Hyperactive Disorder

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Examples of circumstances where FDA WILL REGULATE:

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1. Software functions for the treatment of a specific psychiatric condition (e.g., intended to increase abstinence from a patient’s substances of abuse during treatment).
2. Treatment claims for specific psychiatric conditions where the underlying psychiatric condition may require an urgent or immediate clinical intervention and the delay of the intervention may pose significant harm to the patient, such as treatment of suicidality.
3. Treatment claims for specific psychiatric conditions where the device is intended to replace face-to-face or telehealth treatment sessions.

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