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Collection of Platelets by Automated Methods Guidance for Industry and FDA Review Staff December 2007

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides you, blood establishments, and FDA staff with revised recommendations for the collection of Platelets by automated methods (plateletpheresis). This guidance is intended to help you ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods and resuspended in plasma will be referred to by the product name “Platelets, Pheresis.”

Submit Comments

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: 2005D-0330.


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