FDA Regulation of Diagnostic Testing and COVID-19

Did Food and Drug Administration (FDA) regulations hamper the fight against COVID-19 at a critical juncture? In this short video narrated by Roger Klein, we explore the relationship between the FDA and the CDC in regulating and conducting diagnostic tests.

In 2016, in response to the Zika virus, the FDA designated the Center for Disease Control and Prevention (CDC) as the country’s only diagnostic test manufacturer. In early February 2020, the CDC was ordered to distribute tests for COVID-19 which were faulty and had to have results verified by the CDC laboratory. Only in mid-March 2020, did the CDC loosen regulations which then allowed private hospitals and labs to develop and conduct their own tests.

Could more have been known about the disease at an earlier date if private testing and treatment had been allowed and encouraged? Should the COVID-19 emergency force us to reevaluate the purpose and use of public health regulations and policies?


Differing Views:

Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law


FDA & Health

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at rtp@regproject.org.

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