Oh no you don’t! A month after the U.S. Food and Drug Administration (FDA) announced its decision to discontinue review of applications for Emergency Use Authorization (EUA) submitted by test makers for laboratory developed tests (LDTs) to diagnose COVID-19, the Department of Health and Human Services (HHS) has ordered the agency to resume LDT EUA applications and to do so in a “timely manner.” The new HHS mandate is the latest and perhaps most decisive twist in what has become a somewhat bizarre battle within the administration over regulation of LDTs. The COVID-19 EUA Regulatory Roller Coaster One of the unforeseen results of the public health emergency has been to accelerate the long-running debate over FDA regulation of LDTs. Some of the most innovative and important new COVID-19 tests to receive EUA in the early days of the pandemic were LDTs created by testing companies, universities and medical centers. The demonstrated ability of laboratories to create new COVID-19 tests at a time of desperate need seemed to vindicate the case for relaxing FDA regulation in the interest of innovation and public health. The other impetus to rapid change was the current administration’s policy to cut regulatory red tape for business. […]