We Are Here To Help
We are currently operating under the FDA’s EUA approval guidelines, keeping within the current level of the COVID-19 Pandemic and will continue to do so until otherwise directed by the FDA. The Food and Drug Administration is issuing the guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.
On February 4, 2020 the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of COVID-19 cases in the United States requires a wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.
In light of this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that the prior public participation for this guidance is not feasible or appropriate of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115 (g)(2). This guidance document is immediately in effect, but remains subject to comment in accordance with the Agency’s good guidance practices.