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Volume Limits for Automated Collection of Source Plasma November 1992

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

The increased number of automated plasma collection devices with  varying capacities for tailoring each collection to the specific  donor has resulted in the existence of multiple Food and Drug  Administration (FDA) approved nomograms which specify, for each  piece of equipment, the maximum volume of plasma to be harvested  from each donor category. Current considerations in determining  the volume of plasma to be collected include gender, height,  weight, hematocrit, and in some centers, the length of time in  process or the number of cycles. Because multiple equipment  types commonly coexist in a location, the potential for error  due to application of an inappropriate nomogram is significantly  increased. The use of various anticoagulant solutions, differing concentrations of the anticoagulant, and a range of anticoagulant to plasma ratios, additionally complicates some schema and  creates additional opportunity for error.

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

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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-2013-S-0613.


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