CLIA - Clinical Laboratory
Improvement Amendments
|
|
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Criteria for Waiver: Draft Guidance for Industry and FDA" is available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.
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
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH |