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Breakout

Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements

Wednesday, April 23, 2025
2:55 PM – 3:55 PM East Coast USA Time
In the age of gene sequencing and rapid diagnostic testing for a wide range of symptoms and disease states, the line between what some call Laboratory Developed Tests (LDTs) and InVitro Diagnostics (IVDs) is blurry. Internationally, regulators have taken steps to ensure that accurate and sensitive tests are available to healthcare providers, but the efforts are not all harmonized. The upfront planning of regulatory jurisdictions and design/risk management requirements is essential to avoid wasted time and resources. Internationally, some tests are categorized as LDTs and IVDs in others, with different requirements and differing regulatory expectations.
-Explore how to optimize early regulatory strategies to plan for the various requirements and documentation.
-Discuss best practices for early planning as well as robust design and risk management practices needed to address market access to various jurisdictions.