Digital Mental Health: A Narrative Review of FDA-Authorized Products for Psychiatric Treatment and Diagnostic Support.

Abstract

Objective: To identify FDA-authorized prescription or clinician-directed digital mental health products, including applications and software-enabled devices, for psychiatric treatment or diagnostic support. Methods: FDA Medical Device Databases were searched for records associated with nine product codes relevant to digital mental health. Eligible records were consolidated into distinct product families. Peer-reviewed literature and FDA documentation were reviewed to characterize indications, au