The Human Advantage

Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations

• September 16

On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency's long-standing policy of enforcement discretion.

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