Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection Guidance for Industry June 2005

GUIDANCE DOCUMENT

• Docket Number: FDA-2005-D-0139
• Issued by: Center for Biologics Evaluation and Research

This guidance document finalizes the draft “Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,” dated April 2005, and provides revisions to our previously published final guidance entitled “Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,” dated May 2003. We, FDA, recommend that these revised recommendations be applied prospectively, i.e., that actions taken under previous guidance do not need to be reconsidered subject to the additional provisions of this guidance. This guidance revises the final May 2003 West Nile Virus (WNV) guidance to add a recommendation to defer donors suspected of having WNV infection or diagnosed with WNV infection for 120 days after diagnosis or onset of illness, whichever is later.

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