FDA Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
标准简介
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。标准截图
![Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices[附网盘链接]](/img/20210914103620d1myn.jpg)
标准文档说明
标准文档类型为Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices[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
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices 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 The Secretary of Health and Human Services has delegated to FDA the authority to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and are thus eligible for waiver categorization (69 FR 22849, April 29, 2004). The Centers for Medicare & Medicaid Services (CMS) is responsible for oversight of clinical laboratories, which includes issuing waiver certificates. CLIA requires that clinical 1
laboratories obtain a certificate before testing materials derived from the human body.
Laboratories that perform only tests that are "simple" and that have an "insignificant risk of 2
an erroneous result" may obtain a Certificate of Waiver.
Section 263a(d)(3) of CLIA, 42 U.S.C. § 263a(d)(3), Examinations and Procedures, as modified by the Food and Drug Administration Modernization Act (FDAMA), states the following regarding tests that may be performed by laboratories with a Certificate of Waiver: 1
42 U.S.C. § 263a(b). 2
42 U.S.C. § 263a(d)(2).
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