FDA Removes EUA for N-95 Masks Manufactured in China

In case you missed it, the FDA has now shifted course (as anticipated) and removed the availability of the EUA (Emergency Use Authorization) pathway for filtering facepiece respirators manufactured in China. When COVID-19 first began making its way around the world, the FDA acted quickly to allow PPE (personal protective equipment) into the market to boost supply. However, much of the industry understood that this would not last long.


As manufacturers and distributors submitted more and more EUA applications and the FDA became inundated, the understanding was that this pathway of opportunity would sizzle out. As of last week, it has. Traditionally, these kinds of masks must have NIOSH (a branch of the CDC) certification based on a Memorandum of Understanding between the FDA and CDC. However, the EUA brought with it the ability to enter the market without NIOSH review. This shift demonstrates an even larger shift across all EUAs issued at the start of the pandemic. Be on the lookout for other EUAs including the frequently cited Temporary Guidance on Hand Sanitizer to slowly remove itself.

Read more in FDA’s press release: https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators