Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers 1.0.0

We, FDA, are providing you, blood establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components.  We have received specific questions from blood establishments who have chosen to use the INTERCEPT® Blood System for Platelets and Plasma and who have questions on implementation of this pathogen reduction device.  As a result, we are providing guidance in a question and answer format, addressing the most frequently asked questions.