Memoranda to Blood Establishments

Blood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.

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

Blood Publications

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Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software - 1/13/97 (PDF)

Memorandum to All Registered Blood and Plasma Establishments - Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection - 12/11/96 (PDF)

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) - 7/19/96
(PDF)

Memorandum to Registered Blood Establishments - Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products - 5/29/96
(PDF)

Memorandum to Registered Blood and Plasma Establishments - Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) - 5/16/96 (PDF)

Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen - 3/14/96 (PDF)

Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products - 2/96 (PDF)

Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis - 12/4/95 (PDF)

Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products - 12/95 (PDF)

Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen - 8/8/95 (PDF)

Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT) - 8/8/95 (PDF)

Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma - 6/8/95 (PDF)

Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors - 3/14/95 (PDF)

Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors - 3/10/95 (PDF)

Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products - 2/3/95 (PDF)

Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems - 12/20/94 (PDF)

Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/94) - 11/22/94 (PDF)

Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices - 8/5/94
(PDF)

Memorandum to Registered Blood Establishments - Recommendations for Deferral of Donors for Malaria Risk - 7/26/94 (PDF)

Recipient Serum Samples - 4/6/94 (PDF)

Software Used in Blood Establishments - 3/31/94 (PDF), (Text)

Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis - 12/22/93 (PDF)

Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports - 12/10/93 (PDF)

Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification - 8/19/93 (PDF)

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) - 8/5/93 (PDF)

Deferral of Blood and Plasma Donors Based on Medications - 7/28/93 (PDF)

Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products - 7/22/93 (PDF)

Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs - 12/16/92 (PDF)

Volume Limits for Automated Collection of Source Plasma - 11/4/92 (PDF)

Nomenclature for Monoclonal Blood Grouping Reagents - 9/28/92 (PDF)

Change in Equipment for Processing Blood Donor Samples - 7/21/92 (PDF)

Inspections of Military Blood Establishments, Revised Instructions for Command Notification - 6/18/92 (PDF)

Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA) - 4/23/92 (PDF)

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) - 4/23/92 (PDF)

Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products - 4/23/92 (PDF)

Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures - 4/23/92 (PDF)

Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing - 12/12/91 (PDF)

Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV - 9/11/91 (PDF)

FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) - 9/10/91 (PDF)

Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors) - 4/17/91 (PDF), (Text)

Deficiencies Relating to the Manufacture of Blood and Blood Components - 3/20/91
(PDF), (Text)

Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components - 3/20/91
(PDF)

FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica - 3/15/91 (PDF)

Use of Genetic Systems HIV-2 EIA - 6/21/90 (PDF)

Autologous Blood Collection and Processing Procedures - 2/12/90 (PDF), (Text)

Eight-Hour Hold; Blood and Plasma Inspectors - 11/13/89 (PDF)