Rachael Rettner

The U.S. Food and Drug Administration (FDA) has issued more stringent rules for COVID-19 antibody tests sold in the U.S., after a slew of antibody tests hit the market without adequate proof that they really work, according to news reports.

Under the new rules, companies that are already selling these tests must send the FDA an application for “emergency-use authorization” (EUA), along with data showing the tests’ accuracy, within 10 business days, the agency said in a statement. (An EUA allows medical products to be used under certain emergency situations, such as the COVID-19 pandemic, without undergoing the typically extensive FDA approval process.) The tests will also be expected to meet specific standards for accuracy.



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