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WSJ News Exclusive | FDA’s Shifting Standards for Chinese Face Masks Fuel Confusion

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The FDA has handled the importation of masks from China badly says this report in WSJ. During the shortage FDA let 3500 Chinese manufacturers selling products of wide variations in quality to send masks to the U.S. Millions of these N95 masks are now available imported from China but their reliability is uncertain. The FDA even has the same manufacturers on approved and revoked approval lists creating more confusion. The FDA gave then revoked approval for products that failed quality standards. 

The WSJ found that some of the companies given approval early were just weeks old and had not completed quality review by FDA.

The WSJ reports that more than 60% of foreign made masks nearly all Chinese made failed basic U.S. government quality tests that reviewed 22 brands according to regulatory data. About one fifths of the makers were just weeks old and others made claims that were simply not correct. The FDA acted in a crisis situation so bad actors could take advantage of the situation say experts. 

What happens now. The states of California,Washington and Texas are now checking their supplies of N95 masks to see if all the makers are on authorized lists and not revoked. Many doctors and hospitals are going through much anxiety because of the safety of their N95 masks in close contact situations in eyecare, dental care and other care, is now uncertain.



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