Blood Guidances

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• Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
  5/2021

• Investigational COVID-19 Convalescent Plasma; Guidance for Industry
  (Updated February 11, 2021)  - 2/2021

• Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
  (Updated December 17, 2020) - 12/2020

• Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Guidance for Industry
  12/2020

• Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry
  10/2020

• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Guidance for Industry
  (Updated August 27, 2020) - 8/2020

• Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
  (Updated August 26, 2020) - 8/2020

• Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
  5/2020

• Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
  5/2020

• Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
  4/2020

• Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry
  4/2020

• Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry
  3/2020

• Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry
  2/2020

• Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry
  12/2019

• Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry
  10/2019

• Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry
  (This guidance finalizes the draft guidance of the same title dated July 2018.) - 5/2019

• Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry
  12/2018

• 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; Guidance for Industry
  (This document supersedes the guidance of the same title, dated 5/2010.) - 12/2017

• Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry
  12/2017

• An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
  12/2017

• Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry
  12/2017

• Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday; Guidance for Industry
  9/2017

• Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry
  1/2017

• Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy; Guidance for Industry
  8/2016

• Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Final Guidance
  (This document finalizes the draft guidance of the same titled dated June 2013 and supersedes the guidance document of the same title dated July 2001.) - 12/2014

• Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
  6/2014

• United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128
  6/2014

• Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
  (This guidance finalizes the draft guidance entitled “Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility” dated October 2007) -  4/2013

• 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; Guidance for Industry
  (This guidance finalizes the draft guidance of the same title dated November 2011) - 10/2012

• Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion; Guidance for Industry
  (This guidance document finalizes the draft guidance of the same title dated January 2011.) -  9/2012

• 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
  (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

• Guidance for Industry: Availability of FDA's eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments
  8/2011

• Guidance for Industry: Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide
  6/2011

• "Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); Guidance for Industry
  4/2011

• 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
  (This document supersedes the guidance document of the same title, dated August 2007.) -  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
  11/2010

• 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)
  5/2010

• 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
  11/2009

• Guidance for Industry: Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
  7/2009

• Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
  6/2008

• Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
  12/2007

• 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
  11/2007

• Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
  6/2007

• Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies
  8/2006

• Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
  6/2005

• 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
  10/2004

• Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
  9/2003

• Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
  7/2003

• 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
  12/2002

• General Principles of Software Validation; Final Guidance for Industry and FDA Staff
  1/2002

• Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax
  10/2001

• Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
  7/2001

• Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
  7/2001

• Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
  7/2001

• Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
  7/2001

• Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
  3/2001

• Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001
  2/2001

• Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
  11/2000

• Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
  5/1999

• 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"
  5/1999

• Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
  3/1999

• 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
  2/1999

• Guidance for Industry: Changes to an Approved Application: Biological Products
  7/1997

• Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)
   7/1996

• Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV); Memorandum to Registered Blood and Plasma Establishments
  5/1996

• Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen; Memorandum to Registered Blood and Plasma Establishments
  3/1996

• Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis
  12/1995

• Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen; Memorandum to All Registered Blood Establishments
   8/1995

• Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors; Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations
  3/1995

• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)
  8/1993

• Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products
  7/1993

• Volume Limits for Automated Collection of Source Plasma
  11/1992

• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) 
  4/1992

• FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)
  9/1991

• Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)
  12/1987

• Plasma Derived from Therapeutic Plasma Exchange
  12/1984