https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease?utm_campaign=2020-04-16%20CDRH-COVID-19%20Update%3A%20New%20Policy%20for%20Psychiatric%20Digital%20Health%20Devices&utm_medium=email&utm_source=Eloqua

FDA Issues New Policy on Digital Health Therapeutic Devices for Psychiatric Disorders During COVID-19

The U.S Food and Drug Administration (FDA) has issued an immediately in effect guidance to help expand the availability of digital health therapeutic devices for psychiatric disorders while reducing user and health care provider contact and potential exposure to COVID-19 during this public health emergency. The enforcement policy described in the guidance applies to computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders as well as low-risk general wellness and digital health products for mental health or psychiatric conditions. This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19 .

Read the Guidance Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.