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GUIDANCE DOCUMENT

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method October 2024

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2732
Issued by:
Guidance Issuing Office
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.  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.


Submit Comments

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?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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