Manufacture of blood components using a pathogen reduction device in blood establishments: questions and answers
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, November 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Blood Banks Blood Component Transfusion -- standards Blood Safety United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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. This guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). The recommendations in this guidance apply to blood establishments that intend to manufacture pathogen-reduced platelet and plasma products using an FDA approved pathogen reduction device. Currently, the INTERCEPT® Blood System has been approved for the manufacture of certain pathogen-reduced platelet and plasma products, and the preparation of cryoprecipitated fibrinogen complex. If the product platforms for this FDA approved device change or FDA approves another pathogen reduction device with a similar intended use in the future, the Agency will consider providing additional recommendations to blood establishments. This guidance finalizes the draft guidance entitled “Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers, Draft Guidance for Industry” dated December 2017.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 11 pages)).
- NLM Unique ID:
- 9918351275906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351275906676