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  5. Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle - Class II Special Controls Guidance for Industry and FDA Staff
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle - Class II Special Controls Guidance for Industry and FDA Staff

Read the Special Controls Document

Issue Date: 03/01/2011

Issued By: Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

OMB Control No. 0910-0594
Expiration Date: 8/31/2024

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.

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