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Categorization of Tests

Since November 13, 2003, the Food and Drug Administration (FDA) has had the authority to implement the Clinical Laboratory Improvement Amendments (CLIA) test complexity categorization provisions, which includes, but is not limited to the following:

  • Interpreting the CLIA provisions related to complexity categorization;
  • Holding public workshops and meetings on CLIA complexity categorization; and,
  • Developing and issuing implementing rules and guidance for CLIA complexity categorization.

Refer to the link below to access the FDA CLIA database containing the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000 and the tests categorized by the Centers for Disease Control and Prevention prior to that date.

The following information appears as a download below: 

  • A current list of waived tests, including the HCPCS/CPT code;
  • A list of tests categorized as provider-performed microscopy procedures (PPMP), including the HCPCS/CPT code;
  • A list of tests (CPT-4 and HCPCS codes) subject to CLIA Edits that includes non-waived and non-PPMP tests;
  • A list of laboratory certification (LC) codes [CLIA specialty and subspecialty information] that is for information purposes only; and
  • A list of tests (CPT-4 codes) excluded from CLIA edits within the 80000 series.