Resources for Food and Drug Administration (FDA)

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations

CMA

The Clinical Laboratory Improvement Amendments (CLIA) was established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results. A laboratory is defined to be a facility that performs certain testing on human specimens in order to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body (42 C.F.R. sec. 493.2.). CLIA’s regulatory requirements vary according to the kind of test(s) each laboratory conducts. Tests are categorized as waived, moderate complexity or high complexity. Moderate and high complexity tests are collectively referred to as “non-waived” testing.

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