FDA25 Feb 2021 12:52
Q: What are FDA's priorities with respect to review of EUA requests for COVID-19 tests? (Updated 12/2/20)
A: 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. We prioritize review of EUA requests for tests taking into account a variety of factors, as 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. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests).