The FDA has permitted CLIA certified laboratories to perform Covid-19 testing with diagnostic kits that have yet to receive emergency use authorization (EUA) but have been validated. This accelerated policy by the FDA was implemented without prior public comment because the FDA determined that prior public participation for this guidance was not feasible or appropriate. 

The purpose of this policy is to allow a greater number of laboratories, spread across the continent to begin testing as soon as the kit has been developed and validated, without waiting for EUA approval. Thus allowing rapid, widespread testing for Covid-19, which at the time of this new policy, has infected 100 people and caused six fatalities in the U.S.

"We believe this policy strikes the right balance during this public health emergency. We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical, independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation," said FDA Commissioner Stephen M. Hahn, M.D.