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Product safetyFDAUnited StatesImports

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability

17 September 2026

In plain English

FDA announced final guidance on recommendations for developing blood collection, processing, and storage systems used to manufacture blood components via the buffy coat method.

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Topic
Product safety
Regulator
FDA
Published
17 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The 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) intended for the
The full text is at the source

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