Another U-turn for COVID-19 testing regulation as HHS requires FDA to re-prioritize LDT review

The latest switchback in the U.S.’s regulation of COVID-19 tests sees HHS requiring FDA to review tests it previously said the agency lacked authority over, highlighting the challenge of pursuing a deregulatory agenda in the midst of a pandemic.

On Monday, Assistant Secretary for Health Brett Giroir said HHS is directing FDA to review emergency use authorization (EUA) applications for laboratory developed tests (LDTs) within 14 days of submission; if the agency cannot complete a review in time, it will be conducted by NIH’s National Cancer Institute (NCI)...