We, FDA, are issuing this guidance document to provide you, blood establishments, with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. We also provide information to licensed blood establishments for submitting biologics license application supplements to include leukocytes reduced components. This guidance applies to Whole Blood, Red Blood Cells, Plasma, and Platelets¹  manufactured from Whole Blood or collected by automated methods² . This guidance document finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled “Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products.”

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