Policy for diagnostic tests for Coronavirus Disease-2019 during the public health emergency

This is the third of a series of interim guidance documents, this one originating from the U.S. Food and Drug Administration (FDA). Issued on March 16, this guidance document provides insight into FDA policy for the development, validation, and use of diagnostic tests for Coronavirus Disease-2019 (COVID-19), particularly those tests issued an Emergency Use Authorization (EUA). This guidance applies to not only manufacturers developing and distributing test kits but also CLIA laboratories cleared for high-complexity testing that develop and validate their own tests. The FDA provides background on the topic and then discusses the policy in detail, before closing with its validation study recommendations.

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