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CLIA - Clinical Laboratory
Improvement Amendments

(CLIA Logo)

Background

  • Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standardsforall laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. 
  • A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
  • CLIA is user fee funded; therefore, all costs of administering the program must be covered by the regulated facilities.
  • Centers for Medicare & Medicaid Services (CMS) (formerly Health Care Financing Administration) assumes primary responsibility for financial management operations of the CLIA program. 

Regulatory Categories

  • The categorization of commercially marketed in vitro diagnostic tests under CLIA are now the responsibility of the FDA. FDA has assumed primary responsibility for performing the CLIA complexity categorization functions that include the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential risk to public health:
  • CLIA categorization will also be announced in a Federal Register Notice which will provide opportunity for comment on the decision. FDA reserves the right to reevaluate and recategorize this test based upon the comments received in response to the Federal Register Notice.
  • FDA will revise as necessary criteria for waivers, moderate and high complexities.
  • Categorization Criteria
  • CLIA Waiver Information

Guidance

  • "Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver: Draft Guidance for Industry and FDA" is available in Text and PDF formats

On-line search

  • A CLIA database is now available. This database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000 and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.
  • The records can be searched by Test System Name, Specialty/Subspecialty, Analyte, Document Number, Qualifier, Effective Date and Complexity.
  • You can search on just one field or enter information into multiple fields.
  • You may enter the entire name, but often the search is most successful when you enter just the first word or two, or just the first few letters.
  • The data is updated on a monthly basis.
  • The qualifier field is to expand on the test system for using another manufacturer's reagent on the test system and/or an additional processing step.

Download data

Presentations

  • FDA's CLIA Complexity Process - April 23, 2000
    PPT Text
  • CLIA Update - June 5, 2001
    PPT PDF
  • IVD Roundtable 510(k) Workshop - Update 2003: FDA and CLIA - April 22, 2003
    PPT PDF Text

Other Useful Links

Contact

Send Comments/Questions by e-mail: clia@cdrh.fda.gov

Updated April 30, 2003

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