After emergency approval of more than 440 COVID-19 products, FDA decided to bind EUA!

After issuing emergency use authorizations for more than 400 COVID-19 tests, the U.S. Food and Drug Administration said Wednesday that it is ending its EUA review of new in vitro diagnostics.

Timothy Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a virtual town hall meeting for COVID-19 and Mpox test developers that the agency is finalizing a review of tests already submitted for authorization and expects to submit only a small number of additional tests. It was unclear whether the closing comments also referred to the Mpox EUA, and agency officials did not immediately respond to a request for clarification.

Three years after holding a town hall meeting for test developers, the FDA's Center for Devices and Radiological Health plans to hold the last scheduled meeting in the series on March 22, though Stenzel left the door open for more meetings "if needed."

FDA officials said in a September policy update that they intend to review only a small subset of new EUA diagnostic test requests, and that they encourage developers of all types of tests to seek approval through the de novo or 510(k) premarket review pathway.

Agency officials plan to provide 180 days' notice prior to the end of the EUA declaration, at which time all EUAs issued under the emergency declaration will cease to be valid.