While most common laboratory tests are commercial tests, manufactured and marketed to multiple labs, other tests are developed and validated within one particular laboratory. The new policy states that lab-developed tests will no longer require F.D.A. The administration faced widespread criticism for failing to make coronavirus tests available earlier in the outbreak, and for ongoing shortages and delays. But critics say that freeing all lab-developed tests from F.D.A. with no knowledge of what lab-developed tests are being devised, much less how they are performing.

Source: New York Times August 21, 2020 22:19 UTC