RE: Hmmm8 Oct 2020 08:46
New Q&A response on FDA website:
‘ 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 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. 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, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, 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. 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.’