The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide a policy to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 during this pandemic.
Psychiatric symptoms and psychiatric disorders are presented in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and the International Classification of Diseases, 10th Revision. Common symptoms and disorders include depression, alcohol use disorder , anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder , obsessive compulsive disorder, and post-traumatic stress disorder.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.
