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GUIDANCE DOCUMENT

“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV Guidance for Industry December 2010

Final

“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

Docket Number:
1999D-1878
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Multiple layers of safeguards, including donor screening and testing, are used to reduce the risk of transmitting infection through blood transfusion. However, a person may donate blood early in infection, during the period when the viral marker is not detectable by a screening test, but the infectious agent is present in the donor’s blood (the “window period”). For example, if an individual donates blood on a number of occasions and each donation tests nonreactive for antibody to HCV, but the donor returns and tests repeatedly reactive for antibody to HCV at a later date, prior collections from such a donor could be at increased risk for transmitting HCV.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 1999D-1878.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010