Memoranda to Blood Establishments

• Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software (PDF - 17KB)
  1/13/97
• 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)  (PDF - 21KB)
  7/19/96
• Memorandum to Registered Blood Establishments - Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products (PDF - 26KB)
  5/29/96
• 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) (PDF - 8KB)
  5/16/96
• Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen  (PDF - 15KB)
  3/14/96
• Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products  (PDF - 28KB)
  2/96
• Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis  (PDF - 145KB)
  12/4/95
• Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products (PDF - 27KB)
  12/95
• Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen (PDF - 28KB)
  8/8/95
• 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)  (PDF - 6KB)
  8/8/95
• 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 (PDF - 14KB)
  6/8/95
• Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors (PDF - 2.7MB)
  3/14/95
• Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors (PDF - 11KB)
  3/10/95
• Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products (PDF - 6KB)
  2/3/95
• Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems (PDF - 30KB)
  12/20/94
• 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) (PDF - 11KB)
  11/22/94
• Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices (PDF - 18KB)
  8/5/94
• Recipient Serum Samples (PDF - 5KB)
  4/6/94
• Software Used in Blood Establishments (PDF - 7KB)
  3/31/94
• Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis (PDF - 9KB)
  12/22/93
• Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports (PDF - 8KB)
  12/10/93
• Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification (PDF - 4KB)
  8/19/93
• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) (PDF - 12KB)
  8/5/93
• Deferral of Blood and Plasma Donors Based on Medications (PDF - 9KB)
  7/28/93
• Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products (PDF - 22KB)
  7/22/93
• Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs  (PDF - 11KB)
  12/16/92
• Volume Limits for Automated Collection of Source Plasma (PDF - 7KB)
  11/4/92
• Nomenclature for Monoclonal Blood Grouping Reagents (PDF - 5KB)
  9/28/92
• Change in Equipment for Processing Blood Donor Samples (PDF - 10KB)
  7/21/92
• Inspections of Military Blood Establishments, Revised Instructions for Command Notification (PDF - 12KB)
  6/18/92
• Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA)  (PDF - 10KB)
  4/23/92
• Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  (PDF - 718KB)
  4/23/92
• Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products  (PDF - 1.5MB)
  4/23/92
• 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 (PDF - 4KB)
  4/23/92
• Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing (PDF - 10KB)
  12/12/91
• Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV (PDF - 5KB)
  9/11/91
• FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) (PDF - 15KB)
  9/10/91
• 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) (PDF - 6KB)
  4/17/91
• Deficiencies Relating to the Manufacture of Blood and Blood Components (PDF - 7KB)
  3/20/91
• Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components (PDF - 8KB)
  3/20/91
• FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica (PDF - 9KB)
  3/15/91
• Use of Genetic Systems HIV-2 EIA  (PDF - 6KB)
  6/21/90
• Autologous Blood Collection and Processing Procedures (PDF - 15KB)
  2/12/90
• Eight-Hour Hold; Blood and Plasma Inspectors (PDF - 94KB)
  11/13/89
• Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen (PDF - 6KB)
  10/4/89
• Requirements for Computerization of Blood Establishments (PDF - 7KB)
  9/8/89
• Use of the Recombigen HIV-1 Latex Agglutination (LA) Test  (PDF - 6KB)
  8/1/89
• HTLV-I Antibody Testing (PDF - 4KB)
  7/6/89
• Guidance for Autologous Blood and Blood Components (PDF - 8KB)
  3/15/89
• Use of the Recombigen HIV-1 LA Test (PDF - 6KB)
  2/1/89
• HTLV-I Antibody Testing (PDF - 29KB)
  11/29/88
• Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel 1 (PDF - 6KB)
  10/18/88
• Revised Guidelines for the Collection of Platelets, Pheresis (PDF - 21KB)
  10/7/88
• Criteria for Exemption of Lot Release (PDF - 5KB)
  8/26/88
• Physician Substitutes (Update)  (PDF - 6KB)
  8/15/88
• Discontinuance of Pre-Licensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines (PDF - 5KB)
  7/7/88
• Recommendations for Implementation of Computerization in Blood Establishments  (PDF - 7KB)
  4/6/88
• Control of Unsuitable Blood and Blood Components (PDF - 6KB)
  4/6/88
• Handling of Human Blood Source Materials (PDF - 5KB)
  12/23/87
• Extension of Dating Period For Storage of Red Blood Cells, Frozen (PDF - 4KB)
  12/4/87
• Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) (PDF - 103KB)
  12/2/87
• Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone (PDF - 6KB)
  11/25/87
• Reduction of the Maximum Platelet Storage Period tp 5 Days in an Approved Container  (PDF - 71KB)
  6/2/86
• In Vitro Diagnostic Reagent Manufacturers - Guidance for Labeling for HTLV-III/LAV Antibody Testing (PDF - 8KB)
  12/6/85
• Physician Substitutes (PDF - 5KB)
  12/14/84
• Equivalent Methods for Compatibility Testing (PDF - 5KB)
  12/14/84
• Plasma Derived from Therapeutic Plasma Exchange (PDF - 6KB)
  12/14/84
• Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin / Roche; 13-cis-retinoic acid) (PDF - 5KB)
  2/28/84
• Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes) (PDF - 252KB)
  1/28/81