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April 2024 Challenge

FDA Memorandum to Blood Establishments

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

64 files

  1. More information about "Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software"

    Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software

    By Cliff

    Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software

    75 downloads

       (0 reviews)

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    Submitted

  2. More information about "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)"

    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)

    By Cliff

    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)

    69 downloads

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    Submitted

  3. More information about "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)"

    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)

    By Cliff

    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)

    81 downloads

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    Submitted

  4. More information about "Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen"

    Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen

    By Cliff

    Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen

    89 downloads

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    Submitted

  5. More information about "Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products"

    Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    By Cliff

    Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    71 downloads

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    0 comments

    Submitted

  6. More information about "Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis"

    Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

    By Cliff

    Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

    68 downloads

       (0 reviews)

    0 comments

    Submitted

  7. More information about "Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products"

    Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    By Cliff

    Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    59 downloads

       (0 reviews)

    0 comments

    Submitted

  8. More information about "Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen"

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    By Cliff

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    55 downloads

       (0 reviews)

    0 comments

    Submitted

  9. More information about "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"

    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

    By Cliff

    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)

    50 downloads

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    0 comments

    Submitted

  10. More information about "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"

    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

    By Cliff

    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

    53 downloads

       (0 reviews)

    0 comments

    Submitted

  11. More information about "Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors"

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    By Cliff

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    67 downloads

       (0 reviews)

    0 comments

    Submitted

  12. More information about "Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors"

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    By Cliff

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    56 downloads

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    0 comments

    Submitted

  13. More information about "Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products"

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    By Cliff

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    65 downloads

       (0 reviews)

    0 comments

    Submitted

  14. More information about "Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems"

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

    By Cliff

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

    68 downloads

       (0 reviews)

    0 comments

    Submitted

  15. More information about "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 12/15/9"

    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 12/15/9

    By Cliff

    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)

    105 downloads

       (0 reviews)

    0 comments

    Submitted

  16. More information about "Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices"

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

    By Cliff

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

    98 downloads

       (0 reviews)

    0 comments

    Submitted

  17. More information about "Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk"

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    By Cliff

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    90 downloads

       (0 reviews)

    0 comments

    Submitted

  18. More information about "Recipient Serum Samples"

    Recipient Serum Samples

    By Cliff

    Recipient Serum Samples

    65 downloads

       (0 reviews)

    0 comments

    Submitted

  19. More information about "Software Used in Blood Establishments"

    Software Used in Blood Establishments

    By Cliff

    Software Used in Blood Establishments

    60 downloads

       (0 reviews)

    0 comments

    Submitted

  20. More information about "Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis"

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    By Cliff

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    83 downloads

       (0 reviews)

    0 comments

    Submitted

  21. More information about "Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports"

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    By Cliff

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    92 downloads

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    0 comments

    Submitted

  22. More information about "Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification"

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    By Cliff

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    93 downloads

       (0 reviews)

    0 comments

    Submitted

  23. More information about "Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)"

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

    By Cliff

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

    85 downloads

       (0 reviews)

    0 comments

    Submitted

  24. More information about "Deferral of Blood and Plasma Donors Based on Medications"

    Deferral of Blood and Plasma Donors Based on Medications

    By Cliff

    Deferral of Blood and Plasma Donors Based on Medications

    79 downloads

       (0 reviews)

    0 comments

    Submitted

  25. More information about "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products"

    Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

    By Cliff

    Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

    48 downloads

       (0 reviews)

    0 comments

    Submitted

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