Enforcement Policy For Digital Health Devices For Treating Psychiatric Disorders During The Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance For Industry & FDA Staff

On April 14, 2020, the U.S. Food and Drug Administration (FDA) issued guidance that temporarily expands availability of digital health devices intended to aid treatment for metal heath disorders. The FDA reduced regulatory barriers on devices it believes pose low risk of harm to users. The temporary expansion policies affect two categories of digital devices: 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 . . .