CBER - Blood Guidances


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Blood Guidances

The guidances on this page are arranged in order by date, with the most recent guidance added to the top of the list.

horizonal rule

Blood Publications | Blood Action Plan | FDA Compliance Policy Guides

Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes - 10/28/2004 - (PDF), (Text)
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 - (PDF), (Text)
Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components - 4/23/2004 - (PDF), (Text)
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components- 12/09/2003 - (PDF), (Text)
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion - 9/22/2003 - (PDF), (Text)
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 - (PDF), (Text)

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 - (PDF), (Text)

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"

Since Publication of this guidance, CDC issued a health alert for travelers arriving from Toronto Canada, and updated their case definition. As discussed in the guidance under section II. B. 3., Updated Information on Case Definitions in Areas Affected by SARS, the FDA indicated that you should consult with the CDC website and phone number for updates. Phone (888) 246-2675.

Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/sars/casedefinition.htm.

FEDERAL REGISTER: Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma; Withdrawal of Draft Guidance - 8/22/2003 - (PDF), (Text)

Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma - 11/26/1999 - (PDF), (Text)

Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires - 7/3/2003 - (PDF), (Text)
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis - 6/25/2003 - (PDF), (Text)
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - 5/1/2003 - (PDF), (Text)
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 - (Corrected 2/4/2003) - (PDF), (Text)

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"

Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations - 4/10/2002 - (PDF), (Text)
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 - (PDF), (Text)

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 - (64 FR 73562 - 73563, Dec. 30, 1999) - 12/23/1999 - (PDF), (Text)

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 - (PDF), (Text)

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"

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 - (PDF), (Text)
Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls - 8/28/2001 - (PDF), (Text)
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001 - (PDF), (Text)
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 8/10/2001 - (PDF), (Text)
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture - 8/7/2001 - (PDF), (Text)
Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments - 8/3/2001 - (PDF), (Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001 - (PDF), (Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) - 7/19/2001 (PDF), (Text)
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components - 7/19/2001 - (PDF), (Text)
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 - (PDF), (Text)
Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From An Outside Supplier - 7/11/2001 - (PDF), (Text)
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing - 3/29/2001 - (PDF) (Text)
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 - 2/13/2001 - (PDF), (Text)
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion - 1/23/2001 - (PDF), (Text)
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices - 11/22/2000 - (PDF), (Text)
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - 6/23/2000 - (PDF), (Text)
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria - 6/8/2000 - (PDF), (Text)
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components - 6/6/2000 - (PDF), (Text)
Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128 - 11/1999 - (PDF)
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing - 3/15/2000 - (PDF), (Text)
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 - (PDF), (Text)
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of donor Test Results for Antibody to HCV (Anti-HCV) - 6/17/1999 - (PDF), (Text)

FEDERAL REGISTER Notice of Availability - 6/22/1999 - (PDF), (Text)

Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use - 5/20/1999 - (PDF), (Text)
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products - 5/20/1999 - (PDF), (Text)
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 - (PDF), (Text)
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 - (PDF), (Text)
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 - (PDF), (Text)
Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" - Information Sheet - 9/8/1998 - (Text)

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 - (PDF), (Text)

Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing - 6/11/1998 - (PDF), (Text)
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products - 1/8/1998 - (PDF), (Text)
Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use - 10/07/1997 - (Text)
Guidance for Industry - Donor Screening for Antibodies to HTLV-II - 8/15/1997 - (PDF), (Text)
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software - 1/13/1997 - (PDF), (Text)
Guideline for Quality Assurance in Blood Establishments - 7/11/1995
(NOTE: The text version does not contain Tables 1-8) - (PDF), (Text)
Draft Guideline for the Validation of Blood Establishment Computer Systems - 9/28/1993
(PDF), (Text)
Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1 - 8/8/1989
(PDF)
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 - 12/1987 -
Sections I through IV - (PDF)
Section V - (PDF)
Appendix B, C and D - (PDF)
Appendix E, part 1 - (PDF)
Appendix E, part 2 - (PDF)