The agency said antibody test manufacturers must now apply for emergency use authorization within 10 business days after the products hit the market. If the tests don’t meet the FDA’s criteria, the manufacturer must suspend distribution, the agency said May 4.
The FDA was previously allowing any manufacturer to sell their antibody tests after validating the results themselves and simply notifying the agency of its plans to sell.
Experts have raised concerns about the quality of the more than 100 tests the agency has allowed on the market without review.
The agency will generally give emergency use authorization to tests that can detect 90 percent of people with COVID-19 antibodies and that produce false positives in less than 5 percent of cases, a senior FDA official told Politico.
FDA Commissioner Stephen Hahn, MD, told Politico that the manufacturers of nearly half of the antibody tests already on the market under the old policy are working with the agency to get emergency use authorization.
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