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Emergency Use Authorization of In-Vitro Diagnostics for Infectious Disease
  • Date2017-06-01 16:22
  • Update2017-06-01 16:22
  • DivisionDivision of Strategic Planning for Emerging Infectious Diseases
  • Tel043-719-7271

Emergency Use Authorization of In-Vitro Diagnostics for Infectious Disease
Division of Laboratory Diagnosis Management, CDC
Park Jae-Sun, Choi Young-sill, Yoo Cheon-Kwon

The Emergency Use Authorization(EUA) is a new tool for timely and practical use of unapproved diagnostic products of some infectious diseases as one of the rapid countermeasure responses to infectious disease threat. Recently, Korean Centers for Disease Control and Prevention started the EUA to make available diagnostic tools in civil to identify and respond to serious infectious diseases in collaboration with Ministry of Food and Drug Safety. This article describes the EUA systems in U.S. and WHO and introduces the first two applications of EUA in Korea – Zika virus and MERS – which were approved in 2016 and finally, discusses the prospective of this system.
This public work may be used under the terms of the public interest source + commercial use prohibition + nonrepudiation conditions This public work may be used under the terms of the public interest source + commercial use prohibition + nonrepudiation conditions
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