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United States - Healthcare - Summary Of LDT Rule: An In-Depth Look At The Final Rule Regarding Laboratory-Developed Tests

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape...

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | Venable LLP

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for...

United States - Healthcare - FDA Issues Final Rule Classifying LDTs As Medical Devices

New rule creates premarket review, reporting, quality system, and other requirements for laboratory developed tests...

Exponent : FDA Issues Final Rule Classifying LDTs as Medical Devices

in vitro diagnostic products manufactured by laboratories and used in a single clinical laboratory - as medical devices under the Federal Food, Drug, and Cosmetic Act. The final...

FDA Finalizes Rule Regulating Laboratory Developed Tests | Polsinelli

FDA Publishes Final Laboratory-Developed Tests in Federal Registe

LDT Final Rule: Shifting the LDT Battlefield | King & Spalding

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final...

ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

/PRNewswire/ -- A final FDA rule regulating laboratory-developed tests (LDTs) as medical devices does not address serious concerns raised by ARUP Laboratories...