Blood Guidances

An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
9/2024

Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry
7/2024

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Guidance for Industry
7/2024

Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry
4/2024

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry
10/2023

Investigational COVID-19 Convalescent Plasma; Guidance for Industry
10/2023 (Updated October 13, 2023)

Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry
6/2023

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
6/2023

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
5/2023

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
5/2023

Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
12/2022

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 May 23, 2022) – 5/2022

Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments:  Questions and Answers; Guidance for Industry
11/2021

Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Guidance for Industry
(Updated August 20, 2021)  – 8/2021

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

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

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

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: 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: 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

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