The US Food and Drug Administration on Friday changed its position on a sought-after type of respirator from China, the KN95, announcing that the agency will authorize the mask for use in healthcare settings if it meets certain criteria.
In response to continued respirator shortages, the FDA issued new guidance, authorizing KN95 respirators if certain criteria are met, including evidence demonstrating that the respirator is authentic.
The move comes after conflicting government guidance that caused confusion over how these masks should be used and whether they could be imported into the US.
The FDA did not include these masks on its initial guidance for emergency use issued last month, but the Centers for Disease Control and Prevention said the KN95 masks are “expected to be suitable alternatives” to the N95 masks during the coronavirus pandemic when supplies are short.
The differing guidance left suppliers hesitant to ship masks and US buyers wary of purchasing them.
On March 28, the FDA listed masks from six countries, including Mexico and Brazil, that it found “appropriate to protect public health or safety,” but left the Chinese masks off the list.
Across the globe, N95 masks – considered the gold standard of respirator masks – are in short supply. These masks, which filter out at least 95% of very small particles from the air, are a crucial piece of equipment for doctors and nurses treating the tens of thousands of coronavirus-infected patients in the United States.
But questions about the quality and effectiveness of the similarly named KN95 mask arose as production ramped up in China.
The masks were not listed in the initial FDA emergency use authorization because of “challenges in determining the authenticity” of the imports, said an agency spokesperson, who added that the FDA has already e