As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating psychiatric disorders in its Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (“the Guidance”).
As the Guidance states, “[i]n the context of the COVID-19 public health emergency, the use of digital health technologies … may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine.” The Guidance makes clear that it applies specifically to computerized behavior technology and other digital health therapeutic devices for psychiatric disorders, along with low-risk general wellness and digital health products for mental health or psychiatric conditions. The purpose of the Guidance is to improve the availability of devices used to treat psychiatric conditions remotely without the need for patients to visit healthcare facilities, allowing patients and mental health professionals to avoid in-person contacts.
The Agency temporarily waived four requirements related to: (1) submissions of a 501(k) premarket notification; (2) 21 CFR 806 corrections and removals; (3) 21 CFR Part 807 registrations and listings; and (4) 21 CFR Part 830 and 21 CFR 801.20 unique device identification (UDI). Also subject to the exclusion are prospective clinical data requirements for computerized behavioral therapy devices for psychiatric disorders.
The Guidance also applies to software products that provide wellness recommendations for patients with mental health conditions. One example includes digital health tools that promote and/or track choices to reduce risk of certain psychiatric conditions. However, as the Guidance reiterates, certain software functions are not regulated as devices (e.g., software used for video conferencing, general wellness software functions related to sleep, and functions or reminders to promote social distancing practices). Additionally, digital therapeutics for treating a specific condition, such as substance abuse, would not be exempted under these waivers.
Lastly, the Guidance added labeling recommendations to make clear which products have received clearance and which have not. For example, a computerized behavioral therapy device should include user instructions specifically telling the patient to contact a physician before using the device.
In sum, the Guidance appears to be addressing the mental health needs arising from the pandemic by temporarily waiving requirements for certain digital health devices.