"Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;" Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" dated October 2002. The guidance document provides recommendations for assessing donor suitability and product safety for donors diagnosed with West Nile Virus (WNV) infections or with illnesses potentially caused by WNV. The guidance applies to Whole Blood and blood components intended for use in transfusion and blood components including recovered plasma, Source Leukocytes, and Source Plasma intended for use in further manufacturing into injectable or non-injectable products. These recommendations are intended to reduce the risk of transfusion transmitted WNV, particularly in areas where human cases are occurring.