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                Regulation of the Blood Supply

Regulation of the Blood Supply

                        Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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          Regulation of the Blood Supply
          Review ChecklistRegulation of the Blood Supply Review Checklist
  
  	
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    PrintComponents of the checklist:

These checklists are a composite of bullet points from (1) regulations, (2) guidance documents, and (3) apheresis device manufacturer directions/specifications that have been a useful reference to the minimum requirements that should be contained in apheresis submissions. The checklists are living documents that undergo regular revision as the source materials change. They do not constitute current or future review policy. Note that the device manufacturer directions/specifications are also subject to change at any time and the latest versions from the manufacturer should always be consulted.

**Apheresis RBC Review Checklist:** General represents bullet points from "Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methodsk," February 2001.
	**Leukocyte Reduction Review Checklist:** General represents bullet points from "Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products," May 29, 1996.
	**Platelet Pheresis Review Checklist:** General represents bullet points from "Revised Guideline for the Collection of Platelets, Pheresis," October 7, 1988.
	**Infrequent Plasma Donors Checklist:** General represents bullet points from "Revision of FDA Memorandum of August 27, 1982: Requirements for Infrequent Plasma Donors," May 10, 1995.
	**SOPs and Labeling:** represents bullet points for required documents to submit.
	**QC sheets:** represents regulatory requirements for records and documentation.
	As of the date of the document, each **device manufacturers directions/specifications** for:
	Baxter ALYX
		Haemonetics MCS Plus LN 8150
		Haemonetics MCS Plus LN 9000
		Trima Version 5.1 (should also apply to version 4 and above except where noted)
		Amicus (Baxter)Tools & Resources

Apheresis Submissions Review Checklist

                                                                                  Content current as of:
      03/29/2019
              
              
Regulated Product(s)
		 BiologicsRegulation of the Blood Supply

          
                        Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
          Review Checklist
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