- Docket Number:
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion, with recommendations for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) were falsely positive and that there is no evidence of infection with hepatitis B virus (HBV). Currently, donors who are repeatedly reactive on more than one occasion for anti-HBc (samples from more than one collection from the same donor are repeatedly reactive for anti-HBc) must be indefinitely deferred in accordance with Title 21 Code of Federal Regulations, section 610.41(a) (21 CFR 610.41(a)).
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-2008-D-0263.