BREAKING NEWS

FDA says 27 coronavirus antibody tests no longer comply with its rules

The U.S. Food and Drug Administration said on Thursday it has removed 27 makers of coronavirus antibody tests from its list of vendors who have notified the agency that they were selling a test and plan to apply for emergency use authorization.
Under the FDA's current rules, a vendor must notify the agency it is selling a test, label it as unapproved and submit a request for emergency use authorization within 10 business days from when the test was validated by a certified lab.
The antibody tests removed include those from vendors who voluntarily withdrew and those for which there is not a pending request for the emergency use authorization, the agency said.
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