The FDA has instructed companies that are currently selling coronavirus antibody tests to submit an Emergency Use Authorization (EUA) request and validation data within 10 business days of May 4 or risk removal of their products from the market.
The agency had allowed companies to market their products and then apply for an EUA within 15 days, based on a March 16 guidance aimed at quickly expanding the use of antibody tests in certified labs. But the guidance led to a flood of unapproved tests, many falsely claiming to be FDA-approved.
“Flexibility never meant we would allow fraud,” the FDA said. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
The agency reminded developers that they should not distribute their tests if they haven’t been properly validated or make claims of FDA authorization if they haven’t received EUA approval.