Decoding FDA’s New Final Rule on Laboratory Developed Tests – What’s Next?
Hall Render attorneys Carolina Wirth and Melissa Markey as they delve into the FDA’s new Final Rule on Laboratory Developed Tests (LDTs), issued on April 26, 2024. This rule marks a significant shift in LDT regulation and our experienced presenters will cover the essential aspects you need to know.
During this 60-minute session, Carolina and Melissa will discuss key provisions, exemptions and compliance deadlines, including the phased-in approach to LDT regulation and current enforcement discretion. Gain valuable insights into how these regulations may impact laboratory operations and explore the potential opportunities and challenges within this evolving regulatory landscape.
This webinar is tailored for legal and compliance professionals, health care professionals involved in LDT development and testing and those engaged in day-to-day laboratory operations. Don’t miss this chance to deepen your understanding of the new requirements and their implications for current and future LDTs.
