On February 28, 1992, the Department of Health and Human Services (DHHS) published laboratory standards regulations (57 FR 7002) implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a). The implementing regulations are codified at 42 CFR Part 493. CLIA regulates laboratory testing and requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe the following three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests. 42 CFR 493.5(a).

On January 31, 2000, the responsibility for categorization of commercially available in vitro diagnostic (IVD) tests was transferred from the Centers for Disease Control and Prevention (CDC) to the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).1 This allows IVD manufacturers to submit premarket notifications or applications for tests and requests for complexity categorization of these tests under CLIA to one agency. Per the December 30, 1999, Notice of the Federal Register, FDA/CDRH’s responsibility for CLIA complexity categorization explicitly applies to clinical laboratory devices:

• under premarket review by CDRH,
• under premarket review by other FDA Centers,
• exempt from premarket notification, and
• that are legally marketed and for which the sponsor is seeking a waiver categorization.

FDA/CDRH’s general administrative procedures vary for each of the categories above and are described within this document. This guidance also includes information regarding FDA’s internal administrative processes, including CDRH’s e-copy program which is voluntary for CLIA categorizations. This guidance also includes administrative procedures for categorization applicable to IVDs overseen by other FDA Centers.