Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing ...

The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are ...

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...

The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...

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 ...

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...

The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...