JD Supra

FDA to rescind laboratory developed test rule

The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
RAPS

In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices

The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices ...
JD Supra

FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.
RAPS

As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

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 ...
Becker's Hospital Review

FDA withdraws lab test oversight rule

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 ...
MD&M East

FDA Ditches Application of Medical Device Rules to Lab-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, ...
Morningstar

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner TacroType™ Pharmacogenetic ...
The National Law Review

FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

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