The US Food and Drug Administration (FDA) plans to phase out its general enforcement discretion policy for LDTs over a four-year period, with the first phase of its final rule on LDTs due to come ...

Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

"FDA’s LDT rule struck down in Texas court" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith ...

A district court ruling asserts that the FDA does not have responsibility for the ... regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs).

Published in 2024, the FDA’s ‘Final Rule’ outlined plans to subject lab-developed tests to the same requirements as medical devices.