https://www.wired.com/story/the-fda-tightens-the-rules-for-covid-19-antibody-blood-tests/

The federal government has received plenty of well-deserved flack for slow-rolling the national launch of diagnostic tests for Covid-19. First came the flawed swab-based tests from the Centers for Disease Control and Prevention, followed by a chaotic, lost month of regulatory tango that prevented independent tests from getting scaled and out the door. So when interest arose in a different kind of testing—antibody blood tests, which are used to find evidence of past infection, not a current diagnosis—the US Food and Drug Administration was under pressure to hurry things along. In mid-March, the agency loosened its rules, declaring via an update to its emergency use guidance that antibody tests could be sold without seeking the agency’s approval, provided that manufacturers did their own validation.

Now FDA officials are walking back that decision. Facing criticism that the loosened policy has undammed a flood of flawed tests and fraudulent marketing, agency officials revised their rules Monday to require manufacturers to submit their tests for validation and meet specific standards for accuracy.