FDA
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
FDA
The Food and Drug Administration (FDA) issues Emergency Use Authorizations (EUAs) in order to expand the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19). The outbreak of the aforementioned disease,...
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...
