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GUIDANCE DOCUMENT

Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Final Guidance for Industry September 2012

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0254
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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 This guidance document finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled “Recommendations and Licensure Requirements for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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0254.

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