Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The draft guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive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) used for the manufacture of blood and blood components intended for transfusion using the buffy coat (BC) method. This guidance is intended for manufacturers of blood collection, processing, and storage systems.
Abstract as published in the Federal Register.
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