Laboratory Developed Tests | FDA
Sep 19, 2025 · A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
The LDT Final Rule is Officially Dead: FDA Has No Jurisdiction
Jun 2, 2025 · Not surprisingly, the court victory raises a question about LDT oversight moving forward. ASCP and the vast majority of organizations representing the laboratory community …
FDA LDT Final Rule: Everything You Need to Know
Released on April 29, 2024, this rule aims to enhance patient safety by ensuring LDTs, traditionally developed and used within single laboratories, meet the same stringent standards …
FDA Reverses Final Rule on LDTs: A Win for Labs, a Shift in …
Oct 16, 2025 · LDTs are diagnostic tests designed, manufactured, and used within a single laboratory. They play a critical role in patient care, especially in areas like genetic testing, …
What is an LDT?: Laboratory developed test definition - Ideagen
Jul 9, 2024 · According to the FDA, LDTs are a subset of IVDs designed, manufactured and used within a single clinical laboratory. This contrasts with traditional IVDs, which undergo a more …
The FDA defines a Laboratory Developed Test (LDT) as an in vitro diagnostic test that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA …
LDT Rule Vacated: What It Means for Test Developers - Gardner Law
FDA’s LDT rule was vacated, leaving lab-developed tests in regulatory limbo. Learn what this means for labs, IVD developers, and compliance teams.
The US FDA’s New Rule for Regulating Laboratory-Developed Tests
Oct 11, 2024 · On May 6, 2024, the US Food and Drug Administration (FDA) finalized a new rule to regulate laboratory-developed tests (LDTs).
An introduction to diagnostic testing in laboratories
LDT technologies range from molecular diagnostics to immunoassays and mass spectrometry. An LDT or IVD test can be a simple assay developed to measure a particular biomarker, or it may …
LDT vs IVD: FDA Issues Final Rule [What it Means]
IVDs are produced by device manufacturers who must comply with the FDA’s premarket and postmarket controls. LDTs, on the other hand, are manufactured by laboratories, and (until …