Clinical Laboratory Improvement Amendments - CLIA

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Clinical Laboratory Improvement Amendments


CLIA
Clinical Laboratory Improvement Amendments
United States Clinical Laboratory Improvement Amendments

Homepage: http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htm

CLIA is a user-fee funded federal organization that establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. The section of the statute specifying the criteria for categorizing a test as waived was excerpted without elaboration in the regulations at 42 CFR 493.15(b) and 493.15(c) contained a list of these waived tests as described in Regulations (42 CFR part 493).

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