The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review pathways.
The policy update comes a week after the U.S. Department of Health and Human Services Office of Inspector General released a study that found the FDA’s EUA process authorized problematic tests and frustrated diagnostics developers.
The FDA’s “calculated decisions to increase availability of COVID-19 testing … often came at a potential cost to test quality,” the report said. R…