South Korean foreign ministry on Monday announced three South Korean COVID-19 test kit makers have received a preliminary approval from the U.S. Food and Drug Administration (FDA) to ship their kits to the U.S., although the companies denied they were given such notice.

A Ministry of Foreign Affairs official told reporters Seoul had communicated with the White House Monday morning and confirmed that the U.S. government will soon start a procurement process for the three unnamed Korean sampling kit developers. The U.S. government agreed to give heads-up to the companies as they need to time to prepare.

The ministry kept other details confidential.

The confirmation comes two days after the ministry announced three local COVID-19 test kit developers obtained eligibility for exports to the U.S. and would soon ship their kits to the U.S. without naming the companies.

The hasty announcement stirred confusion among local COVID-19 test kit developers as none of them was notified about the preliminary approval. Some industry observers even raised an issue about the eligibility of the kits’ export only with preliminary approval, citing FDA’s general approval procedure for medicine or medical device sale in the U.S., which usually takes considerable time to get the FDA’s formal approval that is necessary for marketing medicines or medical devices.

But the Korean foreign ministry on Monday confirmed exports of the testing kits are possible with the FDA’s preliminary approval considering the emergency situation in the U.S. where new confirmed cases already crossed 100,000.

The three manufacturers are among the five local developers whose sampling kits were granted emergency use authorization in Korea and seven others that obtained approval only for exports, according to the ministry.

Some Korean companies have been shipping kits on “CLIA” certifications from individual state government allowing temporary use in hospitals and labs.

By Pulse

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]