Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
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Cloud-Based Platform Enlists Quest to Provide COVID-19 Molecular Test Results to Travelers
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Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests
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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
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AMA Creates New PLA Code 0247U for Sera Prognostics PreTRM Test
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FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings
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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
