Virus Tests Made by Individual Labs No Longer Need FDA Review

More individual labs could develop their own tests for Covid-19 and other diseases after a policy shift no longer requiring them to get FDA review before use.

The change, announced on the Department of Health and Human Services’ website this week, applies to diagnostic tests designed, made, and used within a single lab. Labs can still submit the tests to the Food and Drug Administration and request an emergency use authorization, which would allow other labs to use them.

Tests that the FDA doesn’t approve, clear, or authorize won’t get immunity from liability for claims arising from their use during ...