The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19
diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2.

The emergence of the COVID-19 pandemic created significant opportunities for diagnostics developers who moved quickly to bring SARS-CoV-2 detection tests to market under the emergency use authorization (EUA) policy. To get these tests into the hands of healthcare providers as quickly as possible, the FDA was under pressure to be adaptable and offer regulatory flexibility under unprecedented circumstances. This article will review the FDA response to COVID-19, trace the shift from healthcare setting to home-based collection and testing, and explore the regulatory challenges and successes in the transition to at-home diagnostics. Throughout the pandemic, the FDA has clearly committed to providing prompt guidance to COVID-19 response efforts.

This article, written by Precision’s Karen Richards, RAC, and published by Regulatory Focus.


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