Notices

None

Proposed Rules

None

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; Direct Final Rule
  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

• Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Final Rule
  6/11/2011

• General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification - Final Rule
  6/11/2011

• 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