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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Checklist

Components 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)
 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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