Decoding FDA’s New Rule on LDTs: Insights, Implications, and Legislative Considerations

Recorded May 9, 2024  On-Demand Webinar   


Join us as we unpack FDA’s highly anticipated rule on Laboratory Developed Tests (LDTs). This webinar will provide a comprehensive overview of the regulatory landscape, beginning with the historical backdrop for the recently issued rule. We’ll also discuss the nuances of FDA’s approach, including key changes from the proposed rule and enforcement discretion policies that were included in the final rule. Our speakers will walk you through the timeline for implementation, highlighting critical policies and potential litigation challenges. Plus, we’ll explore the legislative components that may shape the future of LDT regulation. Join us and stay ahead of the curve in diagnostic testing regulation.


Nathan A. Brown | Read Bio
Partner, Akin

Jeremiah J. Kelly | Read Bio
Partner, Venable LLP

Moderated by
Andrew Zacher | Read Bio
Of Counsel, Paul Hastings

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