Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry December 2020

GUIDANCE DOCUMENT

• Docket Number: FDA-2014-D-1814
• Issued by: Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document to provide you, blood collection establishments and transfusion services, with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion.   The recommendations in this guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. 

Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12. 

This guidance updates the final guidance of the same title dated September 2019.  The September 2019 guidance finalized the draft guidance of the same title dated December 2018.

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