In Vitro Diagnostics Regulation in the US and Beyond: Trends and Strategies to Navigate Change

In vitro diagnostics have seen incredible innovation during the COVID-19 pandemic, and advances in real world evidence, precision medicine, genetic sequencing, and AI/ML driven software have made this one of the fastest developing industries. However, the regulatory landscape for in vitro diagnostics is in a state of change and uncertainty. Europe's new IVDR law has brought new regulatory challenges for test developers. Meanwhile, FDA has hinted at its intention to regulate laboratory developed tests, and has taken an enforcement posture toward direct-to-consumer, pharmacogenetic, and certain genetic screening tests. This panel will discuss the most important trends in the industry, the VALID Act and Congressional efforts to bring about regulatory clarity, the latest actions from FDA, and how industry should navigate these shifting sands in both the U.S. and internationally.