Diagnostics and Personalized Medicine Conference

This session is intended to provide an interactive discussion with the top leaders from FDA Center for Devices and Health as well as from the Reagan-Udall Foundation for the FDA, a leading academic scholar who has worked on public health strategies during the COVID-19 pandemic, a former FDA leader previously involved with other declared emergency situations and a well-known attorney that has worked with many companies in successful obtaining marketing authorizations for diagnostics.

The goals of this session are to provide stakeholders with an understanding of the flexibility that FDA has exercised during the pandemic in authorizing tests, continuous tracking of tests performance; compliance issues, and how the interactive engagement with test developers has resulted in ensuring devices that are safe and effective for their intended use. Explore whether this flexibility may shape or influence regulatory development of non-Covid-19 assays that meet public health needs in personalized medicine and companion diagnostics. You will also hear the views from those in the public health sector and those working with industry on lessons learned in response to the pandemic.