FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued the Emergency Use Authorization (EUA) with regard to the in vitro diagnostic devices (IVDs) intended to detect antibodies to the virus SARS-CoV-2...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued the enforcement policy for remote digital pathology devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued an enforcement policy dedicated to the telethermographic systems in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
COVID-19
The Food and Drug Administration (FDA or the Agency) issued guidance dedicated to extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices in the context of the Coronavirus Disease 2019 (COVID-2019) caused by the “novel coronavirus” – the virus...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued guidance documents dedicated to certain medical devices becoming significantly important in the current environment: first guidance covers the...
