October 16, 2020

On February 3, 2020, MDIC and FDA hosted a workshop on advancing emergency use authorization (EUA) in vitro diagnostic (IVD) products toward full marketing status at the FDA White Oak Campus in White Oak, Md. The 240 participants included FDA representatives, IVD sponsors, researchers, and organizations providing products and services related to the development and study of IVDs. About 150 people participated in the live meeting and about 90 people joined online.

Participants explored key considerations for using real-world data (RWD) to generate real-world evidence (RWE) to help support IVD products in advancing from EUA to full marketing status (De Novo or 510(k)). They identified challenges and next steps to the use of RWD and RWE to help support full marketing status for more EUA IVD products.

This summary provides a brief overview of each presentation and panel discussion, with links to videos of all presentations and discussions and slides from most presentations.

You can also access all the videos and slides here.