FDA Updates Policies to Allow Imports of Non-Approved Respirators, Including Chinese KN95
The Food and Drug Administration on April 3 issued a new emergency use authorization (EUA) for importing non-NIOSH-approved N95 respirators from China, it said in a letter to importers, manufacturers and healthcare personnel. The EUA “makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic,” FDA said in a new frequently asked question added to its website. Chinese-made KN95 respirators had previously been ineligible for an EUA issued in late March for other non-NIOSH approved respirators “because of concerns about fraudulent products listed as KN95s,” FDA said.
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Also on April 3, FDA updated its guidance on enforcement policies for face masks and respirators during the COVID-19 pandemic. The updated guidance “explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators, if they are on the Centers for Disease Control and Prevention (CDC) list of respirator alternatives during the COVID-19 pandemic,” FDA said. “Although not required, if a KN95 respirator does not have an EUA, importers may want to take appropriate steps to verify authenticity of these products.”
The two separate procedures for importing masks and respirators caused some confusion on a webinar FDA held April 6 on its enforcement policies for the products. FDA said importers may follow either policy to import masks and respirators listed by CDC, whether obtaining approval under the EUA or importing without an EUA. “Our goal is to maximize availability of products,” said an FDA official on the call. “We understand that the most efficient way to get important products in is, as long as you follow the recommendations in our guidance, and if those respirators are listed on the CDC website, they may be imported without notifying FDA,” the official said. But importers are also free to obtain the additional authorization from FDA detailed in the agency’s EUA, she said. “We’re providing multiple options,” said the official on the webinar.
“The FDA is ready and available to engage with importers to minimize disruptions during the importing process,” the agency said. “The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.”