FDA Evaluates South Korea’s COVID Diagnostic Test Maneuvering During Pandemic

June 8, 2021

The FDA took a look at how South Korea handled its authorizations for COVID-19 diagnostic tests in an effort to learn more about the nation’s early success in managing the virus.

The agency found several notable differences in the approaches taken by the U.S. and the South Korean regulators. For example, the FDA didn’t inspect manufacturers’ quality systems for Emergency Use Authorizations, while South Korea did.

The FDA also didn’t put a strong emphasis on the precision of the new tests, while the Korean authority did. In addition, the FDA accepted clinical performance data from devicemakers, while Korea’s Centers for Disease Control and Prevention conducted their own testing.

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