US FDA cancels EUA authorization of dozens of Chinese companies and updates EUA application standards
On May 6, 2020, the U.S. CDC released the results of random inspections of KN95 masks in China. Dozens of EUA-authorized companies failed to meet the quality of mask inspections, and some of them had a filtration efficiency percentage of only one person. number of digits.
On May 7, the U.S. Food and Drug Administration (FDA) website released a list of Chinese manufacturers of masks that are “authorized to import” and comply with the Emergency Use Authorization (EUA) The number of companies required has been reduced to 14!
FDA re-updates EUA application standards
1. Manufacturers with NIOSH certification can apply for Products produced in other countries apply for EUA and provide corresponding certification that can be audited by the FDA;
2. Pass certification from other countries, including China’s National Drug Administration FDA certification, you can apply and provide corresponding certification that can be audited by FDA;
3. If you have been on the EUA list, please submit NIOSHTEB within 45 days -APR-STP-0059 test results, and the maximum and minimum filtering effects must be above 95.
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