Best Practices for Clinical Labs in Turbulent Times

The FDA’s landmark final rule on Laboratory Developed Tests (LDTs) is set to transform the regulatory landscape for diagnostic laboratories. This webinar will provide biomedical diagnostics professionals with a comprehensive overview of quality system requirements (QSR) and key compliance deadlines for the final rule. Actionable strategies to improve quality, which help a lab increase effectiveness, reduce costs, and prepare for the phase-out of enforcement discretion will be discussed

Our expert panel will clarify and outline the FDA’s quality system requirements and highlight the potential global implications of these regulatory changes. Attendees will gain insights into the impact on clinical laboratory operations, including ISO 15189 and ISO 13485 considerations, registration and labeling mandates, and premarket review timelines. Whether you are a laboratory director, regulatory affairs specialist, or diagnostics manufacturer, this session is designed to equip you with the knowledge needed to improve your quality systems and navigate the new compliance landscape.

Learning Objectives:

• Understand the Regulatory Landscape: Explain the FDA’s new Laboratory Developed Test (LDT) regulations, including key compliance milestones, distinctions between LDTs and in vitro diagnostics (IVDs), and the broader implications for clinical laboratories.
• Navigate the Compliance Timeline: Identify the phased enforcement deadlines and corresponding regulatory requirements, including Medical Device Reporting (MDR), quality system standards, registration and listing, and premarket review obligations.
• Evaluate Quality System Considerations: Discuss the role of ISO 15189 and ISO 13485 in laboratory and diagnostic quality management, including their relevance to the new FDA rule and how compliance can serve as a competitive differentiator.
• Assess Strategic Responses for Laboratories / Develop a Strategic Plan to Stay in Compliance: Determine key steps laboratories should take to facilitate compliance, including documentation practices, handling enforcement discretion carve-outs, and preparing for regulatory scrutiny in the evolving diagnostics landscape.