Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method September 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-2732
• Issued by: Center for Biologics Evaluation and Research

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 and on regulatory submissions to Food and Drug Administration (FDA) for such products.  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.  The recommendations also do not apply to blood establishments that intend to manufacture blood and blood components using the BC method with approved or cleared collection, processing, and storage systems.  

---

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2732.

Questions?