FDA updates guidelines for antibody tests

Coronavirus

The FDA is now requiring makers of antibody tests to seek emergency use authorization,

(FOX NEWS) — The FDA has updated its guidelines for antibody tests.

As of Monday, the FDA is requiring companies who sell coronavirus antibody tests to request an emergency authorization to distribute them.

Companies must also submit their validation data to the FDA within 10 business days.

The FDA is also requiring specific performance-threshold recommendations for test developers.

In March, the FDA allowed manufacturers to sell antibody tests without being required to prove their accuracy, and test results have been widely varied.

Copyright 2021 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Video Forecast

More Forecast

Don't Miss