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.

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.