Product Code: 25EL-500-2035
Please note: This is a Single Viewer eCast registration for one participant for this eCast for both the live and on-demand version of this eCast. If you are interested in presenting this program to a group, please see the “eCast Registration Form– Group Viewing” form on the eCast program page.
Access instructions for the live eCast will be provided via email approximately 2-3 business days prior to the live program date. Access instructions for the on-demand version of this program will be provided via email approximately 3-10 business days after the live program has occurred and the on-demand version is available.
Program Description: The FDA’s Final Rule on Laboratory Developed Tests (LDTs) marks a significant shift in the regulatory landscape for many laboratories, with implementation of the Stage 1 phaseout of FDA’s enforcement discretion set to take effect on May 6, 2025. This eCast is designed to equip AABB members with the knowledge and tools needed to navigate this regulatory change. Attendees will gain a comprehensive understanding of Stage 1 requirements, including new medical device reporting requirements, corrections and removals reporting requirements, and quality system requirements. The program will also highlight the broader implications of these regulations on laboratory workflows, quality systems, and patient care. This program will help participants develop effective strategies for compliance while minimizing operational disruptions. Attendees will learn to evaluate their current tests, identify gaps, and implement necessary changes to align with FDA regulations. Additionally, the eCast will provide access to valuable resources and will describe the continuously evolving landscape related to the regulation of LDTs.
