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首页> 美国政府科技报告 >Guidance for Industry and FDA Staff. Class II Special Controls Guidance: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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Guidance for Industry and FDA Staff. Class II Special Controls Guidance: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

机译：工业和FDa工作人员指南。 II类特殊控制指南：通过离心或过滤分离原理操作的自动血细胞分离器装置

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摘要

We, FDA, are issuing this guidance document in conjunction with a Federal Register final rule reclassifying from class III to class II the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components. This guidance document serves as the special control to support the reclassification. This guidance document also serves as the special control for the automated blood cell separator device operating on a filtration separation principle intended for the routine collection of blood and blood components reclassified as class II on February 28, 2003 (68 FR 9530). Special controls, when combined with general controls, ordinarily address the risks associated with use of the device. Following the effective date of a final rule reclassifying the device, any firm submitting a 510(k) premarket notification for an automated blood cell separator device operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components will need to address the issues covered in this special controls guidance. However, the firm need only show that its device meets the recommendations of this guidance or in some other way provides equivalent assurances of safety and effectiveness.

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