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

1:00 PM - 2:00 PM (EDT), Thursday, June 8, 2023 ・ Session Room 209
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.
Former FDA Chief Counsel
Morrison Foerster
Senior Vice President of External Affairs
Corporate Counsel
Amazon Lab126
Placeholder Photo
Associate Director for Scientific and Regulatory Programs
FDA, Center for Devices and Radiological Health
Vice President of Regulatory Policy
Foundation Medicine