Edited by Jeffrey N. Gibbs and Allyson B. Mullen
As dramatically illustrated by the COVID-19 pandemic, In Vitro Diagnostics (IVDs) play a central and growing role in the health care system. These products—whether for infectious diseases, cancer, or any other condition—present both opportunities to advance public health and regulatory challenges. FDLI’s practical guidebook, Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment, explores these regulatory issues and provides insights from leading experts on how to address them.
This book covers the key regulatory topics for IVDs, providing both guidance that can help IVD companies succeed and perspectives on critical policy issues. Topics include the history of IVD regulation, regulatory strategies for applicants, pre-market pathways, clinical trials, analytical testing, complying with quality system regulation, post-market regulation, EUAs, complementary and companion diagnostics, LDT, CLIA, EU regulation, and proposed federal legislation.
Containing sixteen chapters written by top practitioners in the field, this book serves as an invaluable single reference for helping to navigate the complex regulatory landscape of in vitro diagnostics.