STAT May 12, 2022
Mental health tech companies are bracing for the FDA to tighten the reins
In April 2020, the Food and Drug Administration announced an emergency policy giving companies wide berth to release apps to address a mental health crisis that experts feared would only get worse under lockdown. It was a boon to emerging companies developing digital therapeutics for depression, ADHD, substance use, and other conditions. In the years since, they’ve been able to test drive their products in the real world without seeking FDA marketing authorization, which can require years of expensive clinical trials.
Now, companies who took advantage of the freedom to advance their product pipelines are watching anxiously as FDA prepares to roll back the allowances. Mario has...
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