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GUIDANCE DOCUMENT

Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 Guidance for Industry February 2001

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1998-D-0851
Issued by:
Guidance Issuing Office
Center 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 This final guidance document finalizes the draft guidance document entitled “Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods, dated July 1998.

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-1998-D-0851.

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Contact Point
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Food and Drug Administration
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