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US begins crackdown on unvetted virus blood tests:
U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.
The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.
The agency said in a statement that it expects the tests "will not be marketed or distributed." It was unclear if any of the companies would face additional penalties.
Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a "Wild West" of unregulated testing.
[...] Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.
The FDA is now working with the National Institutes of Health and other federal health agencies to vet the accuracy of the tests and determine how they can be used to track and contain the virus.
(Score: 5, Interesting) by HiThere on Monday May 25 2020, @06:45PM (1 child)
A lot of these tests aren't even good at the population level. They're either just before the line of fraud or actually over the line. The FDA should never have let them be sold. The are "unfit for purpose".
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 0) by Anonymous Coward on Monday May 25 2020, @06:49PM
The FDA has no control over tests done in China, South Korea, Italy, etc.