COVID-19: Telethermographic Systems Not OK’d By FDA Can Be Used For Medical Purposes
The temperature-detection devices are the latest target for enforcement policy guidance by the US agency, which says it will look the other way when it comes to regulatory compliance by makers of non-FDA-approved telethermographic systems.
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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.
COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More
In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.
Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.