FREE ON-DEMAND WEBINAR
June 20, 2024

From LDTs to IVDs: Navigating the New Regulatory Landscape

Join us for an insightful webinar covering the evolution and current state of Laboratory Developed Tests (LDTs). We will briefly review the FDA's discretionary enforcement practices over the years to compare them with the newly established regulatory landscape.

The session will delve into the new LDT rule, exploring its implications for laboratories to move their LDTs into the FDA regulated environment of in-vitro diagnostics (IVDs), identifying exempt devices, and discussing continued enforcement discretion.

Key topics will include a detailed timeline for compliance, an overview of FDA requirements such as quality systems and regulatory submissions, and practical advice on initiating processes from quality, regulatory, and clinical perspectives.

Attendees will gain an understanding of how to navigate the new regulatory landscape and effectively move forward in this evolving field.

Specifically, This webinar will cover:

• Overview of LDTs: Participants will gain a comprehensive overview of the history, evolution, and current landscape of Laboratory Developed Tests.
• FDA Enforcement: Insight into the history of FDA discretionary enforcement related to LDTs.
• New LDT Rule Implications: Clarity on the new LDT rule, including its impacts on LDT laboratories, exempt devices, and continued enforcement discretion.
• FDA Compliance Requirements: Detailed knowledge of the FDA requirements for LDT laboratories to navigate quality systems and regulatory submissions, including Q-sub/pre-submission meetings, 510(k), and de novo applications.
• Practical Ways to Move Forward: Recommendations on the appropriate timelines and strategies from quality, regulatory, and clinical perspectives.