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FDA Relaxes Regs For COVID-19 Mental Health Apps

With the increasing concern for people’s mental health as they cope with the COVID-19 crisis, the US agency has relaxed regulations for apps that are intended to treat disorders such as anxiety, depression and insomnia. Certain digital health products would not require a 510(k) clearance during the crisis to enter the market under an immediately-in-effect 15 April guidance document.

Digital Online Mental Health Healthcare and Medicine Concept

Much of the focus during the ongoing novel coronavirus pandemic has been on diagnosing and treating the COVID-19 disease, but health officials are also growing increasingly concerned about the psychological toll it’s having on society. As a direct response, US regulators have published a an immediately-in-effect guidance document that relaxes regulations to allow patients to have more access to digital mental-health products.

The US Food and Drug Administration on 15 April published “Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”...

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