The US Food and Drug Administration (FDA) has published a much-anticipated proposed rule that aims to end its enforcement discretion of laboratory-developed tests (LDT) and make it explicitly clear ...

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous ...

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially ...

As laboratory developed tests (LDTs) have become more advanced and complex, their safety and effectiveness have also generated increased FDA scrutiny. This spring, agency officials took the bold step ...

AUSTIN, Texas--(BUSINESS WIRE)--Many clinical laboratories are now under the gun to achieve Phase One compliance with the Food and Drug Administration’s (FDA) LDT rule before the May 2025 deadline.

AUSTIN, Texas--(BUSINESS WIRE)--With the first important deadline for compliance with the Food and Drug Administration’s (FDA) LDT rule only eight months away, experts urge clinical laboratories ...

In May 2024, the US Food and Drug Administration (FDA) issued its ‘Final Rule’, asserting that laboratory-developed tests (LDTs) - otherwise known as in vitro diagnostics (IVDs) - were medical devices ...

After nearly a year’s worth of trepidation about how laboratory-developed tests (LDTs) could be regulated, there appears to be no path for FDA to assume its oversight. The vacating of the final rule ...

While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The ...

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