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FDA Relaxes Regs For COVID-19 Mental Health Apps

Executive Summary

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.

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