In Shift, FDA Ordered to Provide ‘Timely’ EUA Reviews for COVID-19 Lab Developed Tests

HHS Assistant Secretary for Health and White House coronavirus testing czar Brett Giroir on Monday directed the FDA to review emergency use authorization requests for COVID-19 laboratory developed tests “in a timely manner,” effectively reversing an FDA decision last month to no longer accept voluntary EUA applications for LDTs. 

If FDA is unable to conduct LDT EUA reviews within 14 days, the National Cancer Institute will assist. While the FDA does not have regulatory jurisdiction to require premarket review of LDTs, Giroir said the action will ensure that university labs can secure voluntary EUAs. “Without an EUA, although the tests can be used, [they] cannot receive liability protection [under] the PREP Act,“ he said on a media call.       

Source: https://www.medtechdive.com/news/giroir-directs-fda-to-provide-timely-eua-reviews-for-covid-19-lab-develop/589159/