On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. 1 LDTs are ...

However, the MDA is silent on laboratory tests developed by clinical laboratories for their own use or LDTs. Instead, LDTs have been regulated by CMS under CLIA. In 2021, a bill that would have ...

A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...

Judge Sean Jordan of the Eastern District of Texas struck down the FDA’s final rule that established the agency’s regulatory framework for ensuring the safety and effectiveness of laboratory ...

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal ...

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...

SALT LAKE CITY — Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don't ...

"This is a major victory for patients, as laboratory developed tests play an indispensable role in enabling patients to get timely diagnoses and care for conditions ranging from cancer to emerging ...