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.

The FDA CLIA database contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by Centers for Disease Control and Prevention prior to that date.