FDA To Review Fewer COVID Test EUAs, Focus On Premarket Reviews

FDA on Tuesday (Sept. 27) announced it will only review a “small subset” of emergency use authorization requests for COVID-19 tests, and the agency is encouraging COVID-19 test developers to pursue traditional premarket review through the de novo or 510(k) pathways. The announcement comes six months after Jeff Shuren, director of FDA’s device center, told lawmakers that FDA would begin to “turn off the spigot” on medical device EUAs for coronavirus and turn more of its attention and resources to...