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Clinical Performance Studies For Ivd Medical
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Guidelines for the validation and verification of ...
www.demarcheiso17025.commethods or comparisons with known outcomes are required. For diagnostic methods, clinical sensitivity and selectivity (specificity) should also be evaluated in specific, local patient populations (e.g. hospital, community patients) wherever possible. Ideally the facility will be able to demonstrate performance in line with method specifications.
MLN006270 – CLIA Program & Medicare Lab Services
www.cms.govThe Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human ... Monitors lab Proficiency Testing (PT) performance and approves PT programs Develops, implements, and publishes CLIA rules and regulations FDA Categorizes tests based on complexity Reviews In Vitro Diagnostic (IVD) applications for marketing devices