Quote:
Originally Posted by graciegirl
The antibody tests have no restrictions so they are being sold without verifications from the authorities and now all of them are suspect.
We have a lot of misplaced blame and a lot of unanswered questions. I certainly do not see the lack of answers as "The Villages" fault.
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It is not quite accurate that there are no restrictions on antibody tests being sold. The FDA announced that it would allow the manufacture and sale of tests for COVID on an
emergency basis, not requiring the rigorous approval process usually demanded. The manufacturer must still request FDA approval and submit extensive documentation of the test procedure and quality. If the FDA is satisfied with the application then it approves the test on a temporary basis which will terminate when the emergency is over.
HERE is an example of the FDA granting emergency approval for a blood antibody testing device. You will see it is very specific on what criteria were met by the manufacturer to satisfy the FDA and what ongoing regulations and compliance are required.