Another Strategy Issue—FDA Waives Approvals Of Mental Health Digital Therapies

There are many “rules” that are being bent in this time of crisis. One of them not getting much attention is a recent announcement by the U.S. Food and Drug Administration (FDA) that it will temporarily approve a range of digital health devices intended to aid treatment for mental health disorders (see FDA Guidelines Temporarily Expand Access To Low-Risk mHealth & Telemental Health Devices).

The new rule waives the need for tech developers to submit a 510(k) premarket notification, corrections and removals requirements, registration requirements, and unique device identification requirements. The crisis waiver applies to two categories . . .