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New Rules for LDTs

FDA finalized their ruling on LDTs on May 6, 2024. The final rule clarifies that Laboratory Developed Tests (LDTs) are in vitro diagnostics (IVDs) and are considered devices under the Federal Food, Drug, and Cosmetic Act, even if they are manufactured by laboratories. Under the new ruling, laboratories will be required to register their LDTs and undergo the FDA’s premarket review process for medical devices. As part of the new ruling, the FDA is implementing a 4 years phase out policy to phase out its general enforcement discretion approach so that LDTs will generally fall under the same enforcement as other IVDs1.

The FDA defines Laboratory Developed Tests (LDTs) as in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single clinical laboratory which meets certain laboratory requirements1. IVDs are medical devices, medical tests, or examinations that are performed in samples such as blood, urine, or tissue outside the body. They assist doctors in diagnosing diseases or conditions, monitoring health, and guiding treatment decisions.