- Docket Number:
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Guidance Issuing OfficeCenter 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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If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2013-S-0613.