This essential resource covers:

• The evolving history of LDT regulation: From initial enforcement discretion to the recent final rule, we trace the key legislative attempts (VALID and VITAL Acts) and the FDA’s evolving stance.
  
  
• A clear definition of LDTs: Understand what constitutes an LDT and its vital role in modern healthcare, including identifying emerging health threats and advancing scientific research.
  
  
• Deep dive into the FDA’s final rule: We break down the phased-in approach for compliance, outlining key milestones and requirements for medical device reporting, quality systems, labeling, registration, and premarket review.
  
  
• Practical guidance for next steps: Learn how to prepare your laboratory for compliance, including recommendations for small entities and how to leverage existing quality system frameworks.
  
  
• Insights into the impact on the healthcare ecosystem: Discover the broader implications of these regulatory changes for laboratories, healthcare providers, and patients