In April 2020, as the horrors of the pandemic were beginning to unspool, 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.
The policy was intended to aid people in need while relieving pressure on the health care system and FDA. But it was also a boon to emerging companies developing novel, software-based treatments — sometimes called 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 that took advantage of the freedom to advance their product pipelines are watching anxiously as FDA prepares to roll back the allowances.
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