Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Biologics Guidances

Biologics Guidances

                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Guidances
          Blood GuidancesBiologics Guidances Blood Guidances
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintShould you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.

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
	Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry
	5/2022
	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
	An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
	(Updated March 22, 2022) 3/2022
	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: 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: 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

                                                                                  Content current as of:
      10/17/2023
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsHealth Topic(s)
			  BloodBiologics Guidances

          
                        Allergenics Guidances
          Blood Guidances
          Cellular & Gene Therapy Guidances
          Tissue Guidances
          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop