The U.S. Food and Drug Administration (FDA) will allow imports of Chinese-made KN95 respirator masks, alternative to the widely used N95, into the U.S. amid pressing medical equipment needs across the country.
After authorizing a number of foreign-certified respirators over a week ago, but omitting KN95, a top official from the regulatory federal agency told BuzzNews on Thursday that the agency will not block imports of KN95 masks either.
The FDA’s move comes at a time when the medical staff in the U.S. have been increasingly vocal about their concerns regarding the shortage of medical equipment and gear in their fight against the COVID-19 pandemic.
KN95 masks are six times cheaper than the N95s, according to publicly available market sources.
Although the FDA has not approved the KN95 as of yet, another federal agency in the frontlines of combatting the disease, the Centers for Disease Control and Prevention (CDC), had previously included it on a list of “suitable alternatives” to the N95 mask.
“The FDA is not blocking KN95 mask importations,” said Anand Shah, the agency’s deputy commissioner for medical and scientific affairs in an interview.
He added that importers would be bringing the KN95 into the country at their own risk.
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