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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment.
Furthermore, a blood establishment may adopt more stringent procedures, provided they are. consistent with these recommendations. At each step in this procedure, the predominance of each test and the interpretation of results should be as specified, in the package insert for that kit.
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:
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.