Independent assessment of the FDA’s EUA Process for COVID-19 tests

At the U.S. Food and Drug Administration, much of the focus in 2020 and 2021 has been dominated by the Agency’s response to the COVID-19 pandemic. The Center for Devices and Radiological Health (CDRH) has significantly contributed to the COVID-19 response, including working to help grant emergency use authorizations (EUAs) for over 600 medical devices – more than a ten-fold increase over the number authorized in all prior public health emergencies (PHEs) combined – and authorized over 900 additional medical devices through traditional pathways, for a total of more than 1,700 medical devices authorized. 

“The FDA agrees with the priority recommendations identified by Booz Allen Hamilton in their independent assessment of our COVID-19 response. From the beginning of the pandemic, we have adapted our regulatory approach to address the public’s testing needs and worked actively with COVID-19 test developers to adjust our policies as those needs have changed or the science has evolved. We will continue to take a flexible approach to COVID-19 tests to meet public health needs and increase access to testing for consumers, including at-home diagnostic tests, which remain a top priority for the agency, that is grounded in sound science.” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health 

As of October  8, 2021, the FDA authorized approximately 400 COVID-19 tests and sample collection devices and 593 revisions to such EUAs. 

For the full Booz Allen Hamilton Report, visit the FDA Website.

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