The FDA published a notice in the Federal Register on 13FEB2019 authorizing the emergency use of an in vitro diagnostic device (IVDD) manufactured by Chembio Diagnostic Systems, Inc. This authorization is a direct response to the Ebola virus outbreak in the Democratic Republic of the Congo (DRC) which started in August, 2018 and has since recorded 758 confirmed cases and 455 confirmed deaths (see the latest statistics on the WHO website for the outbreak). The DRC was affected during the last 2 outbreaks of Ebola virus infection, a small outbreak in 2017 and the much larger outbreak in 2014 which significantly affected Guinea, Liberian, and  Sierra Leone and was a source of considerable global concern. The notice describes the basis for the authorization, including the declaration that Ebola virus is a material threat to U.S. national security in 2006 and the declaration by the Secretary of HHS in 2014 that emergency use of IVDD for detection of Ebola would be justified. This latest authorization is part of a series of responses by the FDA to the latest outbreak, which includes other emergency use authorizations for IVDD.

Text Copyright © 2019 Katrina Rogers