The FDA reissued its emergency use authorization Oct. 15 for KN95 respirators made in China that aren’t approved by the CDC’s National Institute for Occupational Safety and Health.
The agency previously granted emergency authorization of the masks — which are made in China and are supposed to provide similar levels of protection as N95 masks — if they met any of three predetermined eligibility criteria, but the new emergency authorization no longer includes that criteria, and the FDA said it will no longer review requests to add to the list of authorized respirators based on those criteria.
“Since the beginning of the COVID-19 public health emergency, we have taken appropriate actions to support the personal protective equipment needs of our health care personnel by issuing EUAs. As part of our continuing work to meet the demands of this public health emergency, we undertook and completed a shortage assessment and concluded that reissuing this EUA was appropriate to reflect the current U.S. demand for these products,” said Suzanne Schwartz, MD, director of the FDA’s Office of Strategic Partnerships and Technology Innovation.
The new emergency use authorization approves only respirators that the FDA approved in its Appendix A.
In May, the FDA removed the emergency use authorization for some KN95 masks after they failed to meet the filtration efficiency rate of 95 percent. A federal report released in August found that only one-third of N95 masks made overseas and approved for emergency use authorization consistently tested above 95 percent particulate filtration efficiency.
The FDA’s rules for KN95 masks have allowed hundreds of mask brands to be sold in the US with little oversight and few quality checks, leaving some states with stockpiles of masks that they no longer trust as protective gear.
Read the agency’s full news release here.
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