FDA Declining to Assess Some Emergency Use Authorization Requests

The FDA’s Center for Devices and Radiological Health is “increasingly declining to review” Emergency Use Authorization (EUA) requests and is “terminating pending EUAs,” for COVID-19 diagnostic tests, according to Hyman, Phelps & McNamara attorney Jeff Shapiro.

One potential reason, he said, is that a particular EUA is likely not a priority given the number of EUAs.

Another potential reason is that there are now so many COVID-19 tests on the market that one of the conditions for granting an EUA — that there are no such products available — no longer applies, he said.