Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV Guidance for Industry October 2004
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
FDA's blood testing rule requires you, an establishment that collects blood and blood components (e.g. Whole Blood and blood components including Source Plasma and Source Leukocytes), to test each donation of human blood or blood component intended for use in preparing a product, including donations intended as a component of, or used to prepare a medical device, for evidence of infection due to specific communicable disease agents(21 CFR 610.40(a)). This rule also requires you to use one or more approved screening tests as necessary to reduce adequately and appropriately the risk of transmission of communicable disease. (21 CFR 610.40(b)) In the preamble to this final rule, we discussed the approved donor screening tests that we believed were necessary to reduce adequately and appropriately the risk of transmission of Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis C virus (HCV). We also stated that as technology advances, we would issue guidance describing those tests that we believe would adequately and appropriately reduce the risk of transmission of communicable disease agents. (66 FR 31146, 31162 June 11, 2001).
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: 2001D-0584.