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Regulatory

Medical devices; Laboratory developed tests

May 6, 2024
A Rule by the Food and Drug Administration on 05/06/2024.
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Regulatory

FDA takes action aimed at helping to ensure the safety and effectiveness of laboratory developed tests

May 2, 2024
On May 14, 2024, the FDA will host a webinar to provide an overview of the final rule and phaseout policy.
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Regulatory

Dear API Abby

It’s back! Dear API Abby is here to answer a series of commonly asked questions about laboratory quality. This time, the American Proficiency Institute (API) is offering...
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Regulatory

Medicare program; Meeting announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests

April 18, 2024
A Notice by the Centers for Medicare & Medicaid Services on April 16, 2024.
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Regulatory

Recent prosecutions of clinical labs for fraud: Practices to avoid

April 12, 2024
Sound management of a clinical laboratory requires an effective compliance program.  An effective compliance program, in turn, requires a thorough and nuanced understanding...
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Regulatory

New updated CLSI AST guidance

March 26, 2024
Important guidance just released.
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