On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19.  The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”

FDA Applies Enforcement Discretion for Digital Health Therapeutic Devices for Psychiatric Disorders

FDA is exercising enforcement discretion for computerized behavioral therapy devices for psychiatric disorders defined in 21 C.F.R. § 822.5801 (product code PWE) and other types of digital health therapeutic devices intended to treat psychiatric disorders but that do not fit under product code PWE (e.g., devices that use a different fundamental technology than computerized behavioral therapy or non-prescription devices).  Under this temporary policy, these devices do not need to submit a 510(k) premarket notification, report corrections or removals, register or list with FDA, or comply with the UDI requirement, provided that the performance and labeling elements outlined in the policy are met.  These requirements include (1) software verification, validation and hazard analysis; (2) appropriate cybersecurity protections; (3) labeling that specifically instructs a patient to contact a physician before using the device; and (4) a prompt where the user acknowledges a recommendation to contact a physician before use.  FDA also recommends that product labeling include 15 elements, including that the labeling must include a “clear statement that the patient contact a physician before using the device,” “provide information about how to access additional resources related to the treatment of psychiatric conditions” and “[a] clear statement of what to do if symptoms are not improving.” 

Here are a few key takeaways:

  •  This policy seems to be relying, in part, on a physician’s involvement in defining the scope of additional functions subject to the Agency’s enforcement discretion policies for software.  Of note, this type of thinking aligns with Congress’s rationale for excluding some healthcare professional-facing clinical decision support software from the definition of a device in the 21st Century Cures Act of 2016 and FDA’s historical position that software products that allow for “competent human intervention” present lower risks than other medical software products.
  • FDA also leaves open practical questions about what happens to new devices on the market once the emergency ends. 

FDA Clarifies Existing Policy on Wellness Products for Psychiatric Disorders

FDA also provides clarity on its existing policies for low-risk wellness and digital health products for mental health or psychiatric conditions.  FDA reiterates that certain software functions are not regulated as devices.  For example, the following software functions are not devices:

  •  Software used for videoconferencing, even when intended for telemedicine.
  • General wellness software functions not related to a specific disease or condition, such as:
    • Promoting relaxation, mindfulness, meditation; or
    • Reducing stress, fatigue, or feelings of isolation due to the COVID-19 public health emergency.
  • General wellness software functions related to sleep, such as:
    • Promoting good sleep;
    • Improving sleep experience;
    • Having more relaxing or restful sleep; or
    • Sleeping through the night or sleeping all night.
  • General wellness software functions generally related to positive mental outlook during the COVID-19 public health emergency.
  • Functions or reminders to promote social distancing practices during the COVID-19 public health emergency.

Other software functions may meet the definition of a device but are subject to FDA enforcement discretion under FDA’s existing guidance documents.  These software functions include the following, among others:

  •  Software functions to promote, track, and/or encourage choices which may help living well or reduce the risk of certain chronic psychiatric disease or conditions.
  • Software functions that help patients with diagnosed psychiatric conditions maintain their behavioral coping skills.
  • Software functions that help patients or users self-manage their conditions without providing specific treatment or treatment suggestions.
  •  Software functions that guide a user through a questionnaire of signs and symptoms for a psychiatric disorder and provides recommendations for the most appropriate types of health care facilities.

FDA also provides examples of regulated devices that are not subject to enforcement discretion, including, for example, software functions for the treatment of a specific psychiatric condition (e.g. intended to increase abstinence from a patient’s substances of abuse).  In addition, FDA will continue to regulate products with treatment claims for specific psychiatric conditions and that are intended to replace treatment sessions.