Blood Guidance Documents

• Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 
  7/28/2009
• Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products 
  3/2009
• Assay Migration Studies for In Vitro Diagnostic Devices 
  1/5/2009
• Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency 
  7/17/2008
• Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) 
  5/20/2008
• Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
  4/25/2008
• Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods 
  12/17/2007
• Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle 
  11/29/2007
• Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes 
  11/21/2007
• Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility 
  10/26/2007
• Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV 
  8/24/2007
• Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay 
  8/08/2007
• Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs 
  6/20/2007
• Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) 
  6/20/2007
• Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components 
  10/27/2006
• Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments 
  10/18/2006
• Guidance for Industry: Bar Code Label Requirements - Questions and Answers 
  10/5/2006
• Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels 
  9/22/2006
• United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (PDF - 1665KB) 
  9/22/2006
• Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies 
  8/08/2006
• Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "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" 
  8/08/2006
• Draft 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 
  7/19/2005
• Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection 
  6/23/2005
• 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) 
  11/24/2004
• Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 
  11/30/2004
• Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes 
  10/28/2004
• Guidance for Industry: 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 HIV-1 and HCV 
  10/21/2004
• Questions and Answers on "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" 
  1/22/2004
• Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components 
  12/09/2003
• Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Guidance for Industry and FDA Staff 
  10/30/2003
• Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion 
  9/22/2003
• 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 
  9/16/2003
• Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires 
  7/3/2003
• Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis 
  6/25/2003
• Question and Answer on FDA Guidance Entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS" 
  4/25/2003
• Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS 
  4/17/2003
• Questions and Answers on FDA Guidance Entitled "Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients" 
  1/15/2003
• Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients 
  12/30/2002
• Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts 
  2/1/2002
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff 
  1/11/2002
• 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 
  1/9/2002
• Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices 
  11/22/2001
• Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax 
  10/17/2001
• Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis 
  8/22/2001
• Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture 
  8/07/2001
• Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers 
  7/19/2001
• Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) 
  7/19/2001
• Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components 
  7/19/2001
• Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors 
  7/11/2001
• Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing 
  3/29/2001
• Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 
  2/13/2001
• Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion 
  1/23/2001
• Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens 
  6/23/2000
• Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria 
  6/8/2000
• Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts 
  12/23/1999
• Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 
  12/14/1999
• Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB) 
  7/15/1999
• Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use 
  5/20/1999
• Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products 
  5/20/1999
• Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use" 
  5/10/1999
• Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product 
  3/8/1999
• Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products 
  2/17/1999
• Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" 
  9/8/1998
• Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing 
  6/11/1998
• Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV) 
  3/20/1998
• Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products 
  1/08/1998
• Guidance for Industry: Donor Screening for Antibodies to HTLV-II 
  8/15/1997
• Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB) 
  7/1997
• Guideline for Quality Assurance in Blood Establishments (PDF - 77KB) 
  7/11/1995
• Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB) 
  3/1992
• Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin (PDF - 1161KB) 
  3/1992
• Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin (PDF - 211KB) 
  1992
• Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) (PDF - 176KB) 
  10/26/1989
• Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB) 
  8/08/1989
• Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB) 
  12/1987
• Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB) 
  8/1985
• Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB) 
  6/1980