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FDA Guidance on Digital Devices for Mental Health During COVID-19

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To protect the public’s health during the COVID-19 pandemic, the Food & Drug Administration (FDA) released guidance expanding the availability of digital health therapeutic devices and applications for psychiatric disorders by clarifying which regulatory requirements it does not plan on enforcing as well as which products do not necessitate FDA oversight. This guidance intends to limit extraneous contact between patients (users) and providers by providing regulatory flexibility for low risk products. The policies will last until the national public health emergency ends.

On April 13, 2020, the FDA released guidance entitled “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the COVID-19 Public Health Emergency.” This document seeks to address urgent public health needs by expanding digital health therapeutic device availability for mental health and psychiatric conditions and reducing potential regulatory barriers for products that pose a low risk to the public. The expectation is that the temporary loosening of restrictions will allow additional products to enter the market quickly and meet the growing public health demand.

These policies involve digital treatments in 2 categories: computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders, and low-risk general wellness and digital health products for mental health or psychiatric conditions.

Computerized Behavioral Therapy and Other Digital Health Therapeutic Devices for Psychiatric Disorders

Digital therapies that fall under this category are prescription-only computerized behavioral therapy devices designed for the treatment of psychiatric disorders. These therapies provide access to tools typically used during face-to-face sessions, such as cognitive behavioral therapy (CBT) and acceptance commitment therapy (ACT).

Given appropriate measures to reduce any undue risk, the FDA will not be enforcing regulatory requirements such as Unique Device Identification standards, listing/registration requirements, or premarket notification submissions. Further, the guidance permits treatment with such devices for both pre-existing and new diagnoses, including those that may have begun during the COVID-19 pandemic. The conditions covered under this category include:

  • Obsessive Compulsive Disorder
  • Generalized Anxiety Disorder
  • Insomnia Disorder
  • Major Depressive Disorder
  • Substance Use Disorder (SUD)
  • Post-traumatic Stress Disorder
  • Autism Spectrum Disorder
  • Attention Deficit Hyperactivity Disorder

Low-Risk General Wellness and Digital Health Products for Mental Health or Psychiatric Conditions

Digital health products that fall into the lower-risk category seek to maintain positive mental health behaviors or ongoing psychiatric treatments. To ensure continued availability of these low risk products, the FDA clarifies the types of products that are not considered devices and thus do not require FDA oversight and the types of products that do fit the definition of a device but for which requirements will not be enforced during the COVID-19 pandemic.

Low-risk, non-device products which do not require FDA oversight might be intended to:

  • Promote relaxation, mindfulness, or meditation; reduce stress, fatigue, or feelings of isolation; or offer help treating mental health conditions that stem from the COVID-19 emergency
  • Provide software functions to promote healthy sleep or better-quality sleep
  • Remind users regularly about the importance of practicing appropriate physical and social distancing during the COVID-19 emergency

Low-risk products that may meet the definition of “device” but for which FDA will not enforce requirements at this time may include products that provide:

  • General wellness functions to track, promote, or encourage choices contributing to a healthy lifestyle, which, in turn, may reduce symptoms of a chronic psychiatric condition (in some cases, these functions may allow psychiatric patients to maintain coping skills)
  • General wellness functions to help users embrace or accept difficult feelings relating to the current emergency
  • Software functions that display messages to support individuals who may suffer from anxiety while recovering from an SUD, which may be exacerbated by the current emergency
  • Software functions that use questionnaires or checklists to aid in the diagnosis and/or management of psychiatric conditions and, when appropriate, encourage users to consult healthcare providers (in some cases, software may recommend treatment facilities based on self-reported symptoms)

Safeguards, Next Steps, and Future Implications for Regulation of Digital Therapeutic Devices

In response to the COVID-19 public health emergency, the FDA has set forth a wide number of policies with increased flexibility by striking a balance between ensuring necessary regulatory oversight and meeting the immediate needs of the public during the pandemic. In the case of medical devices that pose a low risk to the public and have the potential to support those experiencing isolation or practicing social distancing, this guidance clarifies regulations and enforcement priorities to promote psychiatric wellness in a digital format. The FDA’s steps to relax requirements in this guidance align with other policy actions to limit face-to-face care during the pandemic. While these policies are intended to remain in effect only for the duration of the public health emergency, it remains unclear which steps will be taken by the agency and by the industry after the emergency. These circumstances may present an opportunity for digital therapeutics to provide an alternative pathway for safe use going forward. Avalere will continue to track developments in the mental health and substance disorder space, especially in regard to use of telehealth and digital therapeutics.

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