Chinese KN95 masks, the United States "relaxed"

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Time of issue:2020-09-07
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(Summary description)China’s KN95 masks did not receive emergency authorization from the U.S. Food and Drug Administration (FDA, hereinafter referred to as the Food and Drug Administration) last month, which caused confusion among companies that want to import this type of mask. On April 2, an official of the agency told the US news website Buzzfeed News that they would not prohibit the import of Chinese KN95 masks due to the shortage of personal protective equipment in the US.

Chinese KN95 masks, the United States "relaxed"

(Summary description)China’s KN95 masks did not receive emergency authorization from the U.S. Food and Drug Administration (FDA, hereinafter referred to as the Food and Drug Administration) last month, which caused confusion among companies that want to import this type of mask. On April 2, an official of the agency told the US news website Buzzfeed News that they would not prohibit the import of Chinese KN95 masks due to the shortage of personal protective equipment in the US.

Categories:Company News
Author:
Origin:
Time of issue:2020-09-07
Views:0

China’s KN95 masks did not receive emergency authorization from the U.S. Food and Drug Administration (FDA, hereinafter referred to as the Food and Drug Administration) last month, which caused confusion among companies that want to import this type of mask. On April 2, an official of the agency told the US news website Buzzfeed News that they would not prohibit the import of Chinese KN95 masks due to the shortage of personal protective equipment in the US.

Anand Shah, deputy commissioner for medical and scientific affairs of the Food and Drug Administration, said in an interview that the agency does not prohibit the import of KN95 masks. However, although KN95 masks are allowed to be imported, users still have to take risks. Unlike normally certified equipment or equipment authorized in emergency situations, KN95 masks do not have any legal protection or other support provided by the federal government.

Buzzfeed News said that at present, the legality of importing Chinese KN95 masks is still unclear.

"Capitol Hill" news (The Hill) said that the Centers for Disease Control and Prevention (CDC) has included KN95 masks as a backup product to replace other certified masks in emergency situations, but the Food and Drug Administration did not follow the emergency use permit (EUA) Authorized KN95 mask model made in China.

An official of the Food and Drug Administration told the “Capitol Hill” News: “FDA generally does not oppose the import and use of KN95 masks without EUA. Although it is not necessary, if KN95 masks do not have EUA, importers may wish to take appropriate steps. To verify the authenticity of these products. The Food and Drug Administration is ready to contact importers at any time to minimize interference in the import process."

KN95 masks are Chinese substitutes for N95 masks. On March 28, the Food and Drug Administration urgently approved non-N95 masks certified by the European Union and 5 countries (Australia, Brazil, Japan, South Korea, Mexico) in order to alleviate the shortage of medical protective equipment nationwide, but KN95 masks did not receive emergency authorization.

Buzzfeed News said that this has caused considerable confusion for hospitals, medical staff, importers and other companies that have considered using KN95 masks. The public and experts in the import industry have requested the Food and Drug Administration to clear the way for the import of KN95 masks.

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Chinese KN95 masks, the United States "relaxed"

Chinese KN95 masks, the United States "relaxed"

Yimiaoan Labor Insurance Co., Ltd.