Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act Reed Abrahamson, Joelle Groshek, Amy Johnson, Lance Lange, Joy Sharp, Hafsa Warsamee ...

5 steps to navigate the FDA’s new lab developed test rule Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs ...

Those are just some of the uses of lab-developed tests — most often called LDTs — which are in total administered 100,000 or more times a year in labs that developed them all around the country.

FDA’s lab developed test rule could be first check on agency’s power post-Chevron The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency ...

Lab-developed tests look likely to be removed from FDA oversight. That has to change, writes Walter G. Johnson.

The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests.

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...

According to the report, lab-developed tests can cost as much as $15,000 per test. Rochester, Minn.-based Mayo Medical Laboratories, part of Mayo Clinic, pulls in more than $600 million annually ...

The FDA finalized a rule April 29 to treat laboratory-developed tests as medical devices, putting them in the purview of federal oversight. Under the new rules, the FDA will phase in oversight of ...

FDA increases control over laboratory-developed tests after COVID-19 fiasco By Gabrielle M. Etzel April 29, 2024 1:32 pm ...

Traditionally, test developers have used quantitative PCR (qPCR) to create highly specific laboratory-developed tests (LDTs). However, digital PCR (dPCR) is emerging as the preferred technology ...