MDC Blog - MDC

PCCP: A New Option for Changes to Your 510(k)

Posted on September 9, 2024 (September 10, 2024) by Andy Chasteen

Changes to 510(k)

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FDA Updates MDUFA V User Fees for FY 2025

Posted on August 9, 2024 (August 9, 2024) by Andy Chasteen

MDUFA V user fees increasing

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Four New Rapid AST Solutions Hit the Market over Six Months

Posted on July 31, 2024 (August 2, 2024) by Andy Chasteen

Illustration - Antibiotic resistant Pseudomonas aeruginosa bacterium

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How to Build a Culture of Quality in Medical Device Organizations

Posted on May 24, 2024 (May 24, 2024) by Andy Chasteen

Creating a quality focused culture in ivd and medical device organizations

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FDA Finalizes Landmark Ruling: LDTs Officially Regulated as Medical Devices

Posted on April 30, 2024 (April 30, 2024) by Andy Chasteen

Final LDT Rule: FDA to Regulate LDTs as Medical Devices

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The FDA’s Reclassification of IVDs and Implications for LDTs

Posted on March 22, 2024 (March 22, 2024) by Andy Chasteen

FDA to Reclassify Majority of Class III IVDs to Class II

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MDC Welcomes Matthew Faron, PhD

Posted on March 7, 2024 (September 10, 2024) by Andy Chasteen

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Updates from Jan 2024 CLSI AST Subcommitee and Working Groups

Posted on February 20, 2024 (September 10, 2024) by Andy Chasteen

Antimicrobial susceptibility testing

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EU Commission Proposes Extension of IVDR Compliance Deadlines

Posted on January 30, 2024 (January 30, 2024) by Andy Chasteen

IVDD to IVDR

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FDA and CMS Reject the Notion of Expanding CLIA to Oversee LDTs

Posted on January 23, 2024 (January 24, 2024) by Andy Chasteen

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