Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
- CLIA is user fee funded; therefore, regulated facilities cover all the costs of administering the program.
- Centers for Medicare & Medicaid Services (CMS) assumes primary responsibility for financial management operations of the CLIA program.
The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential for risk to public health:
- waived tests
- tests of moderate complexity
- tests of high complexity
CLIA categorizations will also be announced in Federal Register Notices, which will provide opportunity for comment on the decision. FDA may reevaluate and recategorize these tests based upon the comments received in response to the Federal Register Notices.
FDA will revise as necessary criteria for waivers, moderate and high complexities.