Very Brief Blog: FDA Publishes Article, Report on "South Korea's COVID Diagnostics"

FDA has published a 20-page report, summarized in a Health Affairs article, on South Korea's response to COVID from the perspective of diagnostic testing.  The article is authored by the FDA's director for all medical devices, Jeff Shuren, and the director for diagnostics, Tim Stenzel.

• See the Health Affairs article here.
• See the FDA webpage for the report here.
• See the FDA PDF here.

Key points include:

• History of Korean investments and public-private partnerships
• Supporting financial risk for test manufacturers
• Tests were validated in central locations sponsored by the K-CDC
• A national testing strategy was rolled out (plan)
• Networks of testing sites developed (bricks and mortar)
• The quarantine violation rate for positive individuals is estimated to be very very low.