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Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry and FDA Staff DRAFT
This guidance document serves as the special control to support the reclassification of 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 from class III to class II.

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