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Chapter 10 - The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations

Published online by Cambridge University Press:  06 January 2024

By
Erika Tyburski  and
Cathryn Cambria
Edited by
Steven C. Schachter  and
Wade E. Bolton
Steven C. Schachter
Affiliation:
Harvard Medical School
Wade E. Bolton
Affiliation:
VentureWell/Rapid Acceleration of Diagnostics (RADx)
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Summary

The Rapid Acceleration of Diagnostics (RADx®) Regulatory Core was established as part of the National Institutes of Health (NIH)-funded RADx US response to the COVID-19 pandemic. The RADx Regulatory Core is charged with supporting COVID-19 in vitro diagnostic manufacturers admitted into the RADx program with the goal of obtaining Emergency Use Authorization (EUA) and planning for full authorizations to increase COVID-19 testing throughput on the US market. This chapter outlines the EUA process and how it differs from full authorization and describes the inception and evolution of the RADx Regulatory Core, including collaborations made with the NIH, the US Food and Drug Administration, and industry sponsors to successfully bring new tests to the market.

Keywords

FDA510(k)Emergency Use Authorizationlateral flow assay (LFA)homeover-the-counter (OTC)CLIApoint of care (POC)laboratory-based tests
Type
Chapter
Information
Accelerating Diagnostics in a Time of Crisis
The Response to COVID-19 and a Roadmap for Future Pandemics
 , pp. 194 - 210
Publisher: Cambridge University Press
Print publication year: 2024

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References

Soni, A., Herbert, C., Lin, H., et al., Performance of screening for SARS-CoV-2 using rapid antigen tests to detect incidence of symptomatic and asymptomatic SARS-CoV-2 infection: findings from the Test Us at Home prospective cohort study. medRxiv (2022). https://doi.org/10.1101/2022.08.05.22278466.CrossRefGoogle Scholar
FDA, Template for Developers of Molecular Diagnostic Tests (2021). www.fda.gov/media/135900/download.Google Scholar
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Waggoner, J. J., Vos, M. B., Tyburski, E. A., et al., Concordance of SARS-CoV-2 results in self-collected nasal swabs vs swabs collected by health care workers in children and adolescents. JAMA, 328, 10 (2022), 935–940.CrossRefGoogle ScholarPubMed
US Access Board, Best Practices for the Design of Accessible COVID-19 Home Tests. www.access-board.gov/tad/radx.Google Scholar
Eglovitch, J. S., Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics. Regulatory Focus (January 16, 2023).Google Scholar

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