(2020-04-14) Covid19 Digital Health Devices For Psychiatric Disorders Policy

The FDA announces COVID-19 Digital Health Devices for Psychiatric Disorders Policy. 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. (Digital Therapeutics)

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19.