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GUIDANCE DOCUMENT

Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) Guidance for Industry May 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0263
Issued by:
Guidance Issuing Office
Center 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)).

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0263.

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