The Food and Drug Administration (FDA) will no longer block the import of KN95 masks, due to a shortage in personal protective equipment, or PPE, in the United States, an agency official first told Buzzfeed News.
The masks have been described as the Chinese equivalent of an N95 mask which U.S. health care workers use to protect themselves from airborne bacteria and viruses. Though they are allowing imports of the KN95 mask, the product is not FDA-approved, meaning those who use it do so without legal protections.
The Centers for Disease Control and Prevention (CDC) has included the KN95 mask as an alternative to other certified masks that should be used on an emergency basis.
The FDA has not authorized models of KN95 masks made in China under an Emergency Use Authorization (EUA) previously due to concerns of fraudulent products.
“Because of this, the FDA generally would not object to the importation and use of KN95 masks without an EUA,” an FDA official told The Hill. “Although not required, if a KN95 mask does not have an EUA, importers may want to take appropriate steps to verify the authenticity of these products. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.”
The agency announced Thursday that it was loosening regulations on face masks but did not specifically name the KN95 mask.
“Most recently, the FDA issued an EUA to help increase the supply of filtering facepiece respirators by authorizing the use of certain imported disposable respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved for use by health care professionals,” the FDA said in a statement.
“We are continuing to work on strategies to increase the availability of these devices,” the statement continues.
The agency also said it is working with manufacturers to produce masks as the demand has increased for both health care workers and civilians.
“We are providing maximum regulatory flexibility where we can,” the agency added.
The move to allow the import of KN95 comes as GOP lawmakers have shown concern over the U.S.’s dependence on China for medical supplies and various pharmaceuticals.
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Post time: Aug-07-2020