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.
The FDA is currently crafting final transition plans for the hundreds of medical devices and apps given hall passes during the pandemic. Under draft guidelines released late last year, any product making treatment claims that usually require FDA review must submit the required paperwork and have it accepted within 180 days of the final rule’s implementation if they want to stay on the market. The timing of the final rule is unclear, but it could come as soon as this summer or fall.
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