Notices

• Federal Register Notice: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments
  7/28/2016

• Federal Register Notice: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry
  5/15/2015

• Federal Register Notice: Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance
  12/9/2014

• Federal Register Notice: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry
  11/21/2014

• Clarifying Edits to Existing Special Controls Guidance Documents

• Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

• Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability

• Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data
  7/7/2008

• Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification
  8/19/1999

Proposed Rules

• Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period
  1/11/2008

• Requirements for Human Blood and Blood Components Intended for Transfusion and for Further Manufacturing Use
  11/8/2007

• Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction
  10/27/2003

• Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
  7/30/2003

• Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation
  1/18/2001

• Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule
  12/12/2000

• Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule
  8/19/1999

• General Requirements for Blood, Blood Components, and Blood Derivatives; Notification of Deferred Donors
  8/19/1999

• Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Proposed Rule
  8/19/1999

• Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Companion Document to Direct Final Rule
  5/14/1999

Final Rules

• Hepatitis C Virus "Lookback" Requirements Based on Review of Historical Testing Records - Technical Amendment; Final Rule
  12/28/2015

• Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Final Rule
  5/22/2015

• Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma, Final Rule
  1/3/2012

• Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment
  2/8/2008

• Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
  11/30/2007

• Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Correction
  9/24/2007

• Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ("Lookback'')
  8/24/2007

• Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma
  8/16/2007

• Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
  2/1/2007

• Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date
  11/13/2006

• Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures
  2/1/2006

• Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
  10/30/2003

• Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II
  2/28/2003

• Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
  8/6/2001

• General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification
  6/11/2001

• Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents
  6/11/2001

• Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment
  1/10/2001

• Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents
  12/12/2000

• Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human)
  8/28/2000

• Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Confirmation in Part and Technical Amendment
  3/14/2000

• Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
  8/19/1999