© 2004 by Oxford University Press
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
© 2004 Oxford University Press
NEWS |
The Clinical Laboratory Improvement Amendments
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.
- The Centers for Medicare & Medicaid Services (CMS) 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, which 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: waived tests, tests of moderate complexity, and tests of high complexity.
- 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 and for tests of moderate and high complexities.
Source: U.S. Food and Drug Administration (http://www.fda.gov/cdrh/clia/)
Related News Article in JNCI
CiteULike 
Connotea 
Del.icio.us What's this?
J Natl Cancer Inst 2004 96: 500-501.
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||