Archive for: CLIA

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Diagnostics: Other

CMS Releases List of New CLIA-Waived Tests

CMS releases list of 12 new CLIA-waived tests

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Diagnostics: Regulation

CMS Extends Comment Period on Proposed Changes to Proficiency Testing

The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.

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Diagnostics: Regulation

CMS Proposes Rule on Proficiency Testing

On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.

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Diagnostics: Guidance

CMS Publishes CLIA User Fee Update

On December 28, 2018 CMS published its CLIA User Fee Update.

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Diagnostics: Guidance

FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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