Blood Guidances
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The guidances on this page are arranged in order by date, with the most recent guidance added to the top of the list.
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Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods - 12/17/2007
12/14/2007 - The Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection was issued for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). The guidance is being withdrawn based upon comments we have received. FDA may revise the guidance and issue a draft guidance for public comment in the future.
Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility - 10/26/2007
Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs - 6/20/2007
Draft Guidance for Industry: "Computer Crossmatch" (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) - 6/20/2007
Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 10/18/2006
Guidance for Industry: Bar Code Label Requirements - Questions and Answers - 10/5/2006
- 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
- 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"
FEDERAL REGISTER: Draft Guidance for Industry: Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance - 4/11/2006 (PDF), (Text)
FEDERAL REGISTER: Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance - 4/10/2006 - (PDF), (Text)
FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection; Withdrawal of Guidance - 6/30/2005(PDF), (Text)
FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance - 6/28/2005 - (PDF), (Text)
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - 6/23/2005
FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance - 3/9/2005 (PDF), (Text)
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components - 12/09/2003
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion - 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 - 9/16/2003
- 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 - 4/17/2003
- 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"
- 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.
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)
- 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
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers - 7/19/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing - 3/29/2001
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices - 11/22/2000
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products - 5/20/1999
Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" - Information Sheet - 9/8/1998
Guidance for Industry - Donor Screening for Antibodies to HTLV-II - 8/15/1997 - (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 Recommended Methods for Blood Grouping Reagents Evaluation - 3/1992
Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin - 3/1992
Guideline for the Uniform Labeling of Blood and Blood Components - 8/1985