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
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
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
Content:
This guidance document identifies the relevant classification regulation, which provides a description of the applicable automated blood cell separator device (refer to section IV. – Device Description, below). In addition, other sections of this special controls guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with general controls, will ordinarily address the risks associated with these automated blood cell separator devices.