Psychiatric Digital Health Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Psychiatric Digital Health guidance?
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- Digital health technologies may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine.
- These technologies may facilitate “social distancing” by reducing contact with providers and can ease the burden on health care facilities and professionals experiencing increased demand.
What medical device types are covered by this guidance?
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- Computerized behavioral therapeutic devices for psychiatric disorders (Class II, product Code PWE) that are adjunct to clinician supervised outpatient treatment (outline in 21 CFR 882.5801).
- Variations of computerized behavioral therapy devices that are outside of 21 CFR 882.5801.
- Digital health therapeutic devices that treat patients with psychiatric conditions using a different fundamental technology than computerized behavioral therapy (outside of 21 CFR 882.5801).
What kind of psychiatric conditions are envisioned by this guidance?
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- Obsessive Compulsive Disorder (OCD) and Generalized Anxiety Disorder;
- Insomnia Disorder and Major Depressive Disorder;
- Substance Use Disorder and Post-traumatic Stress Disorder;
- Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder (ADHD).
What kind of performance requirements are envisioned by this guidance?
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- Verification and validation should confirm the device implements the intended therapy model;
- Cybersecurity protections are consistent with FDA premarket/postmarket recommendations;
- The labeling specifically instruct the patient to contact a physician before using the device; and
- The user is prompted to acknowledge the recommendation to contact a physician before use.
What are expected label updates?
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- A clear statement for patients to contact a physician before using the device;
- The labeling should provide information related to the treatment of psychiatric conditions, such as references to recommendations for the public made by healthcare professional organizations;
- Device’s indication should include intended psychiatric condition/disorder and patient population;
- A description of the therapeutic method (behavioral therapy, cognitive restructuring, etc.);
- A clear description of the recommended duration and frequency of use;
- Instructions for use, including images that demonstrate how to interact with the device;
- A summary of the device clinical testing including methods and performance or a clear statement that device has not been clinically tested and therefore has unknown benefits and risks.
- A description of the method of determining any treatment recommendations;
- A prominent notice that device recommendations should not be solely or primarily relied upon;
- A warning that the device does not represent a substitution for the patient’s medication;
- A statement as to whether the device is available with or without a prescription;
- Instructions on when the user should consult a health care provider;
- A clear statement of what to do if the symptoms are not improving, and in what time period;
- Instructions on what to do in case of a medical emergency; and
- A clear identification of any device indications/functions that are not FDA-cleared.
What are general wellness examples not regulated as a medical device?
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- General Wellness software unrelated to a specific disease or condition, such as promoting relaxation, mindfulness, meditation or reducing stress, fatigue or isolation feelings.
- General Wellness software related to improving the sleep experience.
- General Wellness software related to mental health or psychiatric conditions.
- Software providing timely reminders to maintain safe physical distancing practices.
What medical device software functions does this guidance temporarily relax FDA enforcement?
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- Software promoting choices for a healthy lifestyle and may help living with chronic psychiatric conditions including Depression, Anxiety, OCD, Autism, ADHD.
- Software reinforcing behavioral coping skills or alleviating increased user anxiety.
- Software teaching users to embrace difficult unwanted thoughts and feelings.
- Software that displays timely messages for users who wants to stop addictive behavior.
- Software helping disease self-management without providing specific treatment suggestions.
- Software highlights common signs and symptoms for a psychiatric disorder and providing a list of possible medical condition and advice on when or where to consult a health care provider.
What are circumstances that are outside scope of this guidance?
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- Software functions for the treatment of a specific psychiatric condition.
- Treatment claims where the underlying psychiatric condition may require an urgent or immediate clinical intervention and the delay of treatment may pose significant harm to the patient.
- Treatment claims for specific psychiatric conditions where the device is intended to replace face-to-face or telehealth treatment sessions.
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