Lab-Developed Virus Tests Get Authorization Without FDA Input

The HHS on Tuesday authorized three lab-developed Covid-19 tests in an unusual move that skirts the FDA’s traditional role to review products.

The tests from the Ponce Medical School in Puerto Rico, the University of Louisville Infectious Diseases Laboratory in Kentucky, and the Hospital of the University of Pennsylvania are already on the market, Health and Human Services testing leader Brett Giroir said in an interview Tuesday. The authorizations give them liability protections and insurance coverage through federal laws passed earlier in the pandemic.

The Food and Drug Administration wasn’t involved in the review process for those tests, Giroir said. ...