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  1. Coronavirus (COVID-19) and Medical Devices

South Korea's Response to COVID-19

The FDA's Center for Devices and Radiological Health (CDRH) has issued a report that describes the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization, and use of diagnostic tests.

Related blog: South Korea’s Implementation of a COVID-19 National Testing Strategy, by Jeffrey Shuren, CDRH Director, and Timothy Stenzel, Director of the CDRH Office of In Vitro Diagnostics and Radiological Health 

From the Executive Summary:

SARS-CoV-2 and the disease it causes, COVID-19, have created an unprecedented public health emergency. In early April 2020, numerous sources around the world declared South Korea’s response strategy had successfully "flattened the curve" of COVID-19.

As South Korea's experience may be informative for future considerations, the FDA reviewed information, including reports in the press and information made publicly available by the South Korean government about their COVID-19 response strategy.

The FDA recognizes different approaches may work for different countries, and this report does not make recommendations for what approaches could or should be adopted in the United States for emerging infectious diseases.

Topics covered in the report include:

  • South Korea's Lessons Learned from Prior Public Health Emergencies
  • South Korea's Development of Tests for COVID-19
  • South Korea's National Strategy
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