A Test of the Emergency (Use Authorization)
System: Challenges in FDA Regulation of
COVID-19 Diagnostics

December 1, 2021By: Jeffrey N. Gibbs & Gail H. Javitt Download PDF

Addressing the COVID-19 pandemic has created many challenges for the Food and
Drug Administration (FDA). One of the largest challenges in coping with COVID-19
has stemmed from the ongoing need for access to accurate diagnostic tests for the
virus. FDA has well-established programs for reviewing in vitro diagnostic (IVD)
tests. The agency also has had experience with accelerating the introduction of new
IVDs in response to a public health emergency by granting Emergency Use
Authorizations. However, no other new virus has overwhelmed FDA’s resources and
decision-making capacity the way the novel coronavirus has. This Article examines
FDA’s evolving approach to regulation of COVID-19 tests since the beginning of the
pandemic, assesses the impact of FDA policies on IVD manufacturers and clinical
laboratories and on the quality and availability of tests, and recommends areas for
improvement. There is an urgent need for prompt FDA examination of its role in
overseeing COVID-19 tests so the agency can evaluate what has gone well—and much
has—and what can be improved. FDA should learn from COVID-19 how to regulate
the new diagnostic tests needed for the next pandemic.

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