CLIA - Clinical Laboratory
Improvement Amendments |
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Background
- 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 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
- Draft Guidance for Industry and FDA Staff: Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
[Text] [PDF]
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.
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 November
18, 2005
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