Zdrowie i gospodarka · 30.12.1999

CLIA Program; Transfer of Clinical Laboratory Complexity Categorization Responsibility

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Health Care Financing Administration (HFCA) are announcing that CDC is transferring the responsibility for the categorization of commercially marketed in vitro diagnostic (IVD) tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to FDA. Categorization is the process of assigning commercial clinical laboratory tests to one of three CLIA regulatory categories (waived, moderate complexity, high complexity). An interagency agreement on the scope and nature of the transfer of this CLIA function was signed on February 27, 1999.