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Lab Developed Tests - US and EU Perspectives

In May 2024, the FDA issued the final rule on laboratory-developed tests (LDTs), outlining the intent to regulate these tests as devices subject to FDA review. General enforcement discretion will be phased out in a four-year staged phaseout plan.  This approach closely mirrors the European Union's approach to regulating tests that are developed in clinical laboratories, which was established with the implementation of the In Vireo Diagnostics Regulation in 2017. 

This session will discuss the FDA's final rule on laboratory developed tests (LDT) and describe the European Union's approach to regulation of LDT.  The session is of interest to manufacturers and laboratories who develop home-brew diagnostic tests.  Attendees will learn about approaches to bringing LDTs to market in the US and EU.

Speaker: Stefan Burde, PhD

Dr. Burde is the Director, Global Growth IVD at TÜV SÜD, a leading full-scope Notified Body under the European Medical Device and In Vitro Diagnostic Regulations (EU) 2017/745 and (EU) 2017/746.  Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 10 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director.  He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.