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Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE
Title:
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DRAFT GUIDANCE
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078732.pdf
Document Type:
Guidance for Industry and FDA Staff DRAFT
Content:
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.