Amendment approval 260 - complexity

A variety of national and international guidelines have been formulated to support method validation. Requirements for the components of a method validation may vary between countries depending on the level of approval that has been obtained. For example, in the United States, Food and Drug Administration (FDA)-approved devices must meet Clinical Laboratory Improvement Amendments (CLlAs) requirements for method validation, if they are deemed of medium or high complexity laboratories operating these tests are subject to inspection and must meet the CLl A quality system standards [12]. However, some POCT devices deemed of low complexity by the FDA may be CLlA-waived such that areas operating only these low complexity tests must simply follow the manufacturer s instructions for those tests to meet CLl A requirements. However, it is not always clear if CLlA-waived devices meet the quahty specification for the analytes being measured. 

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