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GUIDANCE DOCUMENT

Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers Guidance for Industry November 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-6784
Issued by:
Guidance Issuing Office
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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6784.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
[email protected]
(800) 835-4709
(240) 402-8010
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