Issue Date: October 17, 2024
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Draft
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
The purpose of this guidance is to provide recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The recommendations in this guidance do not apply to devices used to manufacture platelet rich plasma or similar products used for therapeutic purposes other than transfusion.
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