FDA eases entry for psychiatry apps during COVID-19 crisis

To address mental health needs during the coronavirus disease (COVID-19) public health emergency, the US Food and Drug Administration (FDA) today announced it would relax certain premarket requirements for computer programs and mobile apps designed to support treatment of conditions such as depression, anxiety, obsessive compulsive disorder and insomnia.

The guidance addresses Class II prescription-only devices and computer programs that support clinician-supervised outpatient treatment of specific psychiatric conditions; further, the guidance can be applied to certain nonprescription devices as well.

The guidance also clarifies FDA's existing policies for low-risk general wellness devices and explains how they apply to conditions relating to COVID-19.

“In the context of the COVID-19 public health emergency, the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine,” FDA states in the guidance. “In addition, the use of such technologies has the potential to facilitate ‘social distancing’ by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals [and] other health care facilities.”

FDA will not require submission of 510(k) premarket notifications, corrections and removal notifications, registration and listing requirements, and unique device identification (UDI) requirements for computerized behavioral health devices and other digital health therapeutic devices for psychiatric disorders where those devices do not create an undue risk during the COVID-19 emergency. Further, the agency notes that it does not intend to require special controls for such products, including prospective clinical data on their use. 

Developers must continue to perform software verification, validation and hazard analysis and demonstrate that the programs or apps implement the therapeutic modality as intended. Cybersecurity protection requirements also must be met. Among product label requirements is an affirmation by the patient that they understand they must contact a physician before using the device, even in cases where the device is marketed directly to the patient.

The guidance further underlines that FDA does not intend to examine low-risk general wellness apps or enforce applicable regulatory requirements for such devices and and notes that apps or programs that promote relaxation, reduce feelings of stress or isolation or promote sleep hygiene may claim that they “may aid users in living well during the COVID-19 public health emergency”.

Products that fall outside the guidance include those designed to treat a specific psychiatric condition (without clinician supervision), those that make claims to treat conditions requiring urgent psychiatric care (such as suicidality) and those that aim to replace face-to-face or telehealth psychiatric care.

Guidance