About This File
- Docket Number: FDA-2017-D-6784
- Issued by: Center for Biologics Evaluation and Research
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.