FDA Administrative Procedures for CLIA Categorization
标准简介
Administrative Procedures for CLIA Categorization[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。标准截图
![Administrative Procedures for CLIA Categorization[附网盘链接]](/img/20210914103549hrdx0.jpg)
标准文档说明
标准文档类型为Administrative Procedures for CLIA Categorization[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Administrative Procedures for CLIA Categorization Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction On February 28, 1992, the Department of Health and Human Services (DHHS) published laboratory standards regulations (57 FR 7002) implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a). The implementing regulations are codified at 42 CFR Part 493. CLIA regulates laboratory testing and requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe the following three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests. 42 CFR 493.5(a). On January 31, 2000, the responsibility for categorization of commercially available in vitro diagnostic (IVD) tests was transferred from the Centers for Disease Control and Prevention (CDC) to the Food and Drug Administration (FDA) Center for Devices and Radiological Health 1 (CDRH). This allows IVD manufacturers to submit premarket notifications or applications for tests and requests for complexity categorization of these tests under CLIA to one agency. Per the 1
64 FR 73561, December 30, 1999. See also the delegation to FDA to categorize commercially available in vitro diagnostic tests and perform associated functions (69 FR 22849, April 27, 2004).
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