FDA OK’s Insomnia Treatment Through Software Pre-Cert Program
Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.
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The pandemic has led to a rise in sleep problems. Somryst seeks to address chronic insomnia by training the body and brain to fall asleep faster and stay asleep longer.
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.
There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them
The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.