Device Lawyer: LDT Performance Data May Spur Labs To Pursue EUA

Newly published performance data for COVID-19 laboratory-developed tests show FDA’s desire to be more transparent with test developers and, according to a medical device industry lawyer, could persuade labs seeking to manufacture tests to pursue FDA authorization, even though they’re no longer required to have premarket or emergency authorization from the agency. Labs have been allowed to sidestep review since HHS announced that FDA would no longer require LDTs to go through premarket review before coming onto the market, stating...