FDA (CBER)
GUIDANCE FINAL
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method
Published: 9/16/2026Detected: 9/16/2026
Summary preview
Provides recommendations to support consistent, controlled blood collection, processing, and storage when manufacturing blood components using the buffy coat method, emphasizing process design and quality controls…
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