This chapter explores the quality management system re-prioritization efforts employed by Rapid Acceleration of Diagnostics (RADx®)-supplied content experts to support rapid product development and commercialization of COVID-19 diagnostic tests. The chapter also explores the interplay between quality, development, manufacturing, and risk management. While the chapter is applicable to companies of all sizes, particular emphasis is placed on describing a roadmap for small businesses and start-ups without the mature quality management systems and teams in place that a larger company may have.

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.