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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance document provides the recommendations of the Food and Drug Administration (FDA) for the use of FDA cleared automated blood cell separators in blood establishments for collecting single and double units of Red Blood Cells (RBC). This guidance also describes the information to be included in a license application or supplement. This final guidance document finalizes the draft guidance document entitled Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods, dated July 1998.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 98D-0545.