What To Know: FDA Laboratory Developed Tests (LDT) Final Rule

In May 2024, the FDA released the final rule on Laboratory Developed Tests (LDTs), significantly altering the regulatory landscape for these crucial diagnostics.

The FDA's new policy aims to ensure the safety and efficacy of LDTs while maintaining patient access and trust. However, the rule has sparked controversy among industry leaders, who argue it could hinder innovation and patient care. This article delves into the essentials of LDTs, the key points of the FDA's regulation, the enforcement timeline, and the varied industry reactions. Read on for a comprehensive understanding of the final rule and its implications for LDT manufacturers and healthcare providers.