The Trump administration unexpectedly announced that the FDA will no longer regulate some lab tests, including those for COVID-19. In addition to potentially allowing unreliable COVID tests on the market, the decision creates an opening for more bogus CAM tests.
Jann Bellamy on August 27, 2020
The U.S. Department of Health and Human Services (HHS) announced last week that the FDA can no longer require some lab tests, including tests for COVID-19, to undergo FDA review prior to going on the market, a move that surprised many. The announcement covers only laboratory developed tests (LDTs), that is, tests assembled and used within a single lab. This can include tests developed by academic and medical center labs as well as testing behemoths like Quest, Genova, and LabCorp. HHS did not exempt tests made by one company and sold to other labs or commercial firms. […]