SILVER SPRING, Md.—In early October, the Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services (HHS), announced that it would cease reviewing SARS-CoV-2 Emergency Use Authorization (EUA) submissions for lab-developed tests (LDTs).
As noted on the FDA’s website regarding the shift, “We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs. We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product.”
The agency has, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility, such as point-of-care tests (POC), home collection tests and at-home tests. The FDA notes it has also done so for tests that would significantly increase testing capacity, such as tests that reduce reliance on test supplies and high-throughput, widely distributed tests.
“In light of this and the recent HHS announcement that FDA will not require premarket review of LDTs, to make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time,” the agency explained. “FDA continues to prioritize review of EUA requests for POC tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.