Direct Links to important GMP Blood Product Guidelines

FDA Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

This final guidance provides comprehensive current recommendations, including new recommendations for deferral of donors with possible exposure to the agent of vCJD.

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FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

In this guidance document FDA provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for HIV-1/HCV NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV-1 RNA and HCV RNA. This document contains recommendations regarding product disposition (§ 610.40(h)), and donor management (§ 610.41 and § 630.6) based on the results of NAT and serologic testing for markers of HIV-1 and HCV infection on samples, collected at the time of donation, from donors of human blood and blood component donations.

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

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.

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FDA Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE

This guidance document serves as the special control to support the reclassification of from class III to class II the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components from class III to class II.

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FDA Guidance for Industry: 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)

This guidance provides medical device manufacturers of communicable disease tests, information about performing studies to support modifying the indication for use to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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FDA Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donations of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of H

FDA has licensed nucleic acid tests (NAT) as tests to screen blood donors for HIV-1 ribonucleic acid (RNA), and HCV RNA; and these licensed tests can detect evidence of infection at a significantly earlier stage than is possible under previously approved tests using antibody or antigen detection technology; including the HIV-1 p24 antigen test.

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FDA Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components

the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122).

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Guidance for Industry:Notifying FDA of Fatalities Related to Blood Collection or Transfusion

Help for report fatalities related to blood and blood component (blood) collection or transfusion

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FDA Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS

This guidance document provides FDA's revised recommendations for assessing donor suitability and blood product safety with respect to Severe Acute Respiratory Syndrome (SARS).

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FDA Guidance for Industry Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

This document provides recommendations to blood establishments, about testing donors of blood and blood components for syphilis, and the actions we recommend that you take regarding donors and their donations in relation to those test results.

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GMP Conferences by Topics

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