The US Food and Drug Administration has published a final guidance aimed at small entities that produce laboratory-developed tests (LDT). The agency published a final rule in April stating that it ...

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 U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The ...

The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, ...