FDA link21 Feb 2020 13:36
2019 Novel Coronavirus Emergency Use Authorization
On February 4, 2020, pursuant to section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the 2019-nCoV. Pursuant to section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) subject to the terms of any authorization issued under section 564(a) of the Act.
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)