Adapting to the New LDT Regulatory Reality: The Path to Compliance

The FDA's long-awaited Final Rule on Laboratory Developed Tests (LDTs) is here, marking a significant shift in the regulatory landscape for diagnostic testing. Released on April 29th, 2024, and published in the Federal Register on May 6th, this rule brings LDTs under the same regulatory umbrella as other in vitro diagnostic (IVD) devices. The FDA believes this change will better protect patient health and safety by ensuring consistent oversight and quality standards across all diagnostic tests.

Join us for an insightful webinar where RQM+ Director for IVD Global Regulatory Affairs, Margot Borgel, and Senior Principal Consultant and IVD expert, Bethany Chung, will dive into the key provisions of the Final Rule, its impact on laboratories, and actionable strategies for successful compliance. They will draw from their deep expertise and discussions at the recent Association of Medical Diagnostics Manufacturers (AMDM) annual meeting to provide you with the most up-to-date insights.

In this webinar, you will:

• Understand the expanded enforcement discretion for certain LDTs, including grandfathering provisions for currently marketed tests
• Explore the phased implementation approach over four years and key compliance milestones
• Learn about the explicit classification of LDTs as medical devices and its implications
• Discover actionable insights and preparation strategies, including compliance readiness, documentation and process improvement, and staff training
• Gain valuable guidance on navigating the evolving regulatory landscape and ensuring seamless compliance

Who should attend:

• Quality Assurance Managers and Directors
• Regulatory Affairs Professionals
• Laboratory Managers and Directors
• Product Development Teams
• Clinical Affairs Professionals
• Compliance Officers

PresenteRS

Margot Borgel, Ph.D.
Director of IVD Global Regulatory Affairs

Margot Borgel, Ph.D. is the Director for IVD Global Regulatory Affairs at RQM+ where she supports our clients in their IVD regulatory journey and provides technical and regulatory advice through the entire product lifecycle. Prior to RQM+, Margot was a Technical Specialist at BSI, where she performed technical reviews for IVDR, IVDD and UKCA certification. She is especially passionate about certification of high-risk devices and enjoyed seeing these devices through IVDR certification while at BSI. Before her notified body work, Margot worked for Immucor, Inc. where she held roles in R&D, manufacturing technical support and manufacturing.

Bethany Chung, Ph.D., RAC
Senior Principal Consultant

Bethany has a Ph.D. in biomedical engineering and loves all things quantitative. She has more than 10 years of experience with medical devices in the clinical space. Prior to joining the regulatory world, she was a clinical researcher specializing in ML and AI-based devices, and she is currently in the Clinical and Post-Market Practice at RQM+.