Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The guidance provides recommendations for all platelet products, including platelets manufactured by automated methods (apheresis platelets), whole blood derived (WBD) platelets, pooled platelets (pre-storage and post- storage) and platelets stored in additive solutions. The draft guidance replaces the draft guidance of the same title dated March 2016.