At present, the epidemic situation in the United States is still serious, and the shortage of epidemic prevention materials such as masks still troubles the American people. However, just yesterday, the U.S. Food and Drug Administration (FDA) revoked the EUA authorization of several Chinese mask manufacturers on the grounds of substandard performance. Currently, there are only 14 Chinese mask manufacturers that have obtained emergency authorization from the FDA. Before May 7, there were 87 Chinese mask manufacturers that had obtained emergency authorization from the FDA. I believe that after seeing this, many sellers are not very clear about what EUA is. EUA is a temporary authorization issued by the FDA, also known as an emergency use authorization. Due to the impact of the epidemic, there is a shortage of masks in the United States. It takes too long to obtain authorization from the U.S. FDA through formal channels. In order to alleviate the shortage of protective materials, the FDA has specially issued some temporary policies to quickly authorize products that meet the regulations so that these products can be supplied to the U.S. market as soon as possible to alleviate the shortage of supply. Previously, according to FDA documents, masks produced in China were required to meet one of the following three requirements to obtain EUA authorization:
Manufacturers with one or more NIOSH (National Institute for Occupational Safety and Health) certified products that produce other models of filtering facepiece respirators (FFRs) in accordance with applicable authorized standards in other countries/regions may be verified by FDA; For those authorized in other regions outside of China, FDA can conduct verification; FDA can verify if there is a test report issued by an independent testing laboratory that shows that the product performance meets the applicable test targets. This time, in addition to reissuing the EUA and greatly shortening the list of allowed imports (attached), the FDA also made the following revisions: 1. Revise the eligibility criteria to allow for accreditation based on acceptable performance of standards for independent laboratory testing records; 2. Eliminate the ability of importers to apply for EUA and instruct manufacturers to provide a list of authorized importers; 3. Add recognition of the registration certificate of China National Medical Products Administration (NMPA), which will be verified by the FDA. In short, the FDA's requirements for Chinese manufacturers have become more stringent, and the difficulty of obtaining EUA authorization has also increased. Just yesterday, many sellers were permanently banned and had their funds frozen by Amazon for selling masks and other epidemic prevention materials, so they went to the Amazon office in Shenzhen to seek an explanation. A netizen wrote a poem for this, which also expressed the bitterness and sweetness of sellers during the epidemic. At present, the control of masks is becoming more and more strict , and we hope that all platform sellers will abide by the rules, otherwise you may lose both your money and the goods. Source: Maiwen |
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