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In March, the FDA allowed companies to start selling tests without providing evidence that they were working to address the Corona virus pandemic, but over time some tests turned out to be inaccurate or fraudulent, while other companies claimed that it could be used in home, which is What the FDA does not allow.
According to the Daily Mail website, it made clear that the United States Food and Drug Administration (FDA) said it was taking action because some vendors had made false claims about the tests and their accuracy, and the companies would now have to show test your work or risk being recalled.
Fda
Last March, the FDA was under pressure to increase testing options, so the agency allowed companies to start selling tests as long as they notified the agency of their plans and filed a disclaimer, even if they were not approved by the FDA.
The policy’s goal was to allow the “flexibility” necessary to increase production rapidly, according to officials.
The decision came after weeks of criticism from doctors, laboratory specialists, and members of Congress who said lack of FDA oversight led to disorganized testing.
FDA Test Approval Text
“However, flexibility has never meant that we will allow fraud,” Dr. Anand Shah, Deputy Commissioner of the Food and Drug Administration, said in a statement. “Unfortunately, we see unscrupulous actors marketing fraudulent test kits and using the epidemic as an opportunity to benefit Americans.”
The agency admitted that there were problems with phishing and false marketing among the 160 tests released in the United States, where some companies claimed that their tests could be used at home, although the FDA did not allow such use.
In a statement, the FDA said that, given antibody tests, access and accuracy have taken precedence over COVID-19 antibody tests. And the FDA will continue to take steps to strike the right balance of assurance that the antibody test is accurate. Reliable, with timely access to tests such as constantly changing conditions and public health needs. “
To date, the US Food and Drug Administration. USA The FDA has conducted 11 antibody tests, which means that its methods, materials, and accuracy have been surpassed by agency regulators.
Statement by the United States Food and Drug Administration
Companies that currently have test kits on the market without FDA permission will now be required to submit formal requests to regulators within 10 business days, as manufacturers released 10 days later will be able to deliver their orders after their tests are validated.
Additionally, the United States Food and Drug Administration (FDA) previously advised against using antibody tests to diagnose coronavirus because it takes time to develop the antibodies.
