WASHINGTON — The Food and Drug Administration on Monday announced that antibody test developers must meet higher quality standards and seek authorization from the administration in order to keep their tests on the market.
The department previously allowed companies to validate their own data in bringing antibody tests to market, a controversial move that unleashed more than 100 tests with wildly variable degrees of quality. Under the new policy, coronavirus test developers will have to meet certain markers of accuracy and submit an application for emergency authorization within 10 days of submitting their data.
“Our expectation is that those that can’t do that will withdraw their product from the market and we will be working with them to help them do that,” FDA Commissioner Stephen Hahn said on a call with reporters.
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