27 Jul 2021
Posted in Medical Devices
Withdrawing FDA EUA COVID-19 PCR tests could have huge impact on US testing industry
Following the CDC announcement that FDA emergency use authorization (EUA) for its COVID-19 PCR test will be withdrawn at the end of 2021;
Dara Lo, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers her view:
“This planned withdrawal could mark a bellwether of EUA approved COVID-19 tests coming to an end. This would have a huge impact on the entire COVID-19 testing industry in the US, which is currently comprised almost entirely of COVID-19 tests with only FDA EUA approval. In contrast to fully FDA approved medical tests, EUAs are only given during a declared emergency; outside of this, an EUA cannot be given and cannot be used.
“With the significant decline in COVID-19 testing in the US reported in the first half of the year, and the wide availability of COVID-19 vaccines, this state of emergency cannot last forever. Yet, COVID-19 testing will remain paramount in the monitoring of the prevalence of COVID-19, as well as vaccine efficacy. So even when the pandemic passes, COVID-19 tests will still be needed, similar to how influenza testing is regularly used.
“If and when FDA EUA comes to an end, manufacturers of COVID-19 tests will need to seek regular FDA approval, which can require even more clinical evidence than what was required for an EUA.”