FDA announces no longer ban on Chinese KN95 mask - Industry news

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FDA announces no longer ban on Chinese KN95 mask

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According to US media reports, with the rapid increase in the number of people infected with 2019 ncov in the US, the US Food and Drug Administration (FDA) has finally "let go" of kn95 mask, which adopts Chinese standards. A senior FDA official said Thursday that the agency will not block the import of kn95 mask from China.
People ride their bikes in the open streets of Washington, D.C., on April 2. According to statistics released by Johns Hopkins University on Tuesday, the number of confirmed cases in the United States has increased to 236339, making it the country with the largest number of confirmed cases.


Kn95 is known as the Chinese version of the N95 mask, and American medical staff use the N95 mask to protect themselves from bacteria and viruses in the air, the report said. However, although kn95 mask can be imported, the product has not been approved by FDA, which means that people using this mask will not be protected by law.


The United States Centers for Disease Control and Prevention (CDC) has listed kn95 mask as a backup product to replace other certified masks in case of emergency, but FDA has not authorized kn95 mask models made in China under the emergency use authorization (EUA)



FDA officials told the Capitol Hill that "FDA will not generally object to the import and use of kn95 mask without authorization of EUA. Although not required, if kn95 mask does not have an EUA, the importer may wish to take appropriate steps to verify the authenticity of these products. FDA stands ready to engage with importers to minimize disruption in the import process. "


Earlier, the FDA announced on Thursday that it would relax the regulation of masks, but did not specifically mention kn95 mask.

In a statement, the FDA said, "recently, the FDA issued the EUA, which can help increase the supply of filter masks by authorizing the use of certain imported disposable protective masks for medical and health professionals that are not approved by the National Institute of occupational safety and health (NIOSH). We will continue to explore strategies to increase the availability of these devices. "



The FDA also said it is working with manufacturers to produce masks because of increased demand from healthcare workers and the public. The FDA statement added, "we are providing as much regulatory flexibility as possible."

As the FDA allows kn95 mask to be imported from China, some Republican lawmakers are concerned that the United States relies on China for medical supplies and various drugs.


Previously, buzzfeed, a US News website, reported in March 29 that China's kn95 mask is an alternative to the N95 mask, but the US Food and Drug Administration (FDA) refused to allow it to enter the US. On March 28, in order to alleviate the shortage of medical protective equipment nationwide, the FDA approved the non N95 masks certified by the European Union and five countries (Australia, Brazil, Japan, South Korea, Mexico), but kn95 mask was not authorized.



At the regular press conference of the Ministry of Foreign Affairs held on April 1, in response to the question raised by reporters, "the FDA refused to allow kn95 mask to enter the United States. Can China confirm it? What's the comment on it?" Foreign Ministry spokesperson Hua Chunying said, "I have seen relevant reports. I don't know the specific situation. If the report is true, I don't know why the US side decided to do so. What I can say is that under the current situation of the epidemic, masks are urgently needed by all countries, and there is also a large demand in China. Chinese enterprises are making full use of their power, working overtime and working day and night to meet domestic demand and at the same time try to provide guarantee for the prevention and control of epidemic situation in various countries. Indeed, the supply of anti epidemic materials also involves specific issues such as the differences in product certification standards of different countries and regions. But these problems should not be obstacles to the cooperation of anti epidemic materials. "

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