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Blood Guidance Documents
Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion. 2
This guidance document finalizes the draft guidance of the same title dated January 2011, 9/2012
- Draft Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers (PDF - 482KB)3
8/2012
- Draft Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations (PDF - 209KB)4
8/2012
Draft Guidance for Industry Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria 5
This guidance replaces the draft guidance entitled “Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria” dated June 2000. 6/2012
Draft Guidance for Industry: Amendment to Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products (PDF - 65KB)6
This draft guidance is intended to amend the guidance entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products,” dated May 2010. 6/2012
Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus (PDF - 168KB)7
11/2011
Guidance for Industry: Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection (PDF - 50KB)8
This guidance supplements the FDA 1987 Memorandum by providing recommendations for a requalification method for reentry of deferred donors who test repeatedly reactive for HBsAg. 11/2011
Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components (PDF - 114KB)9
10/2011
Guidance for Industry: Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments 10
8/2011
Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications. (PDF - 104KB)11
7/2011
DRAFT Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma (PDF - 57KB)12
7/2011
Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide 13
6/2011
Guidance for Industry: "Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) 14
4/28/2011
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle 15
11/29/2007, Updated: 3/2011
Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay 16
8/08/2007, Updated: 3/2011
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 17
This document supersedes the guidance document of the same title, dated August 2007. 12/2010
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion 18
12/2010
Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application 19
11/2010
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 (PDF - 318KB)20
5/2010
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 (PDF - 198KB)21
5/2010
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) (PDF - 125KB)22
5/2010
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 858KB)23
10/2009, Updated: 12/2009
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 (PDF - 68KB)24
11/6/2009
Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection 25
8/2009
Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 26
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 27
3/2009
Assay Migration Studies for In Vitro Diagnostic Devices 28
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 29
7/17/2008
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) 30
4/25/2008
Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods 31
12/17/2007
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 32
11/21/2007
Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility 33
10/26/2007
Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs 34
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 35
10/27/2006
Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments 36
10/18/2006
Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels 37
9/22/2006
United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (PDF - 1.6MB)38
9/22/2006
Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies 39
8/08/2006
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection 40
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) 41
11/24/2004
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 42
11/30/2004
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes 43
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 44
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" 45
1/22/2004
Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - Guidance for Industry and FDA Staff 46
10/30/2003
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion 47
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 48
9/16/2003
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires 49
7/3/2003
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis 50
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" 51
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 52
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" 53
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 54
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 55
2/1/2002
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 56
1/11/2002
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices 57
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 58
10/17/2001
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis 59
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 60
8/07/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers 61
7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) 62
7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components 63
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 64
7/11/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing 65
3/29/2001
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 66
2/13/2001
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens 67
6/23/2000
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 68
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 69
12/14/1999
Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)70
7/15/1999
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use 71
5/20/1999
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products 72
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" 73
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 74
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 75
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)" 76
9/8/1998
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing 77
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) 78
3/20/1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products 79
1/08/1998
Guidance for Industry: Donor Screening for Antibodies to HTLV-II 80
8/15/1997
Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)81
7/1997
Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)82
7/11/1995
Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2.1MB)83
3/1992
Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin (PDF - 1.1MB)84
3/1992
Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin (PDF - 211KB)85
1992
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) (PDF - 176KB)86
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 - 1.7MB)87
8/08/1989
Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1.2MB)88
8/1985
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)89
6/1980
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