Navigating the FDA Phase Out Policy: A Comprehensive Guide for Laboratory Developed Tests (LDT)

Join us for an insightful webinar that will provide an in-depth overview of the FDA’s phase-out policy and its impact on laboratories. This webinar is designed to help laboratories understand and navigate the various stages of the phase-out policy, the associated risks, and the steps needed to ensure compliance.  

  1. Overview of Phases: We will walk you through each stage of the phase-out policy, starting from May 6, 2025, one year after the publication of the final LDT rule. We will discuss the expectations of the FDA at each stage, including compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, Quality Management System Requirements (QMSR), registration and listing requirements, labeling requirements, investigational use requirements, and premarket review requirements for IVDs offered as LDTs.  

  2. Update on State of the Business: We will provide an update on the current state of the business, including a discussion…