Description
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.
Scope & Applicability
Product Classes
6Assessing Donor Suitability and Blood and Blood Product Safety
Blood component subject to the recommendations in this guidance
WNV is unlikely to be transmitted through derivatives manufactured from plasma
The products to which the uniform container labeling standard applies.
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component intended for further manufacture
Stakeholders
4Individuals providing blood or HCT/Ps; Individual providing blood, tissues, or organs
must be notified of low post-collection platelet counts
Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
FDA advisory body discussing malaria testing strategies
Regulatory Context
Attributes
2deferral periods we are recommending are based on a 120 day potential viremic period
Required label for quarantined products used in research
Identified Hazards
Hazards
1relevant communicable disease agent or disease; Pathogen identified as a risk for transmission through blood transfusion and organ transplantation
Related CFR Sections (3)
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR606.171§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
(a) Who must report under this section? You, a licensed manufacturer of blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, must report under this section. If you arrRead full regulation →
- 21CFR606.170§ 606.170 Adverse reaction file.
(a) Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written report of the investigation of aRead full regulation →
Related Warning Letters (10)
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Microvascular Tissue, Inc.
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See Also (8)
- Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (Status: Draft)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry (Status: Final)
- Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)
- Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry (Status: Final)
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)