Vaccines, Blood & Biologics
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Blood Notices, Proposed and Final Rules
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Notices
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) 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 Drft Gdnce for Idty: Use of Nclc Acid Tsts to Rdc the Rsk of Trnsms of W Nile Vrs From Dnrs of Whl Bld and Bld Cmpnts Itnd for Trnsfsn and Dnrs of Cels, Tis, and Celr and Tis-Bsd Pdcts; Reqt for Dat 7/7/2008 Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification 8/19/1999
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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 Manufacture Use
11/8/2007Revisions 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
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Final Rules
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 Curt Gd Mnfting Prtice for Bld and Bld Compnts; Notifi of Cnsgnes and Tranfsn Recips Rcving Bld and Bld Compnts at Incrd Risk of Trnsmit Heptis C Virus Infect ("Lkbck'') 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 Distr of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Mkting Act of 1987; Prescription Drug Amndmts of 1992; Delay of Applicability Date 11/13/2006 Distr of Bld Deriv by Reg Bld Establi that Qualify as Hlth Care Entities; Prescrip Drug Mrkting Act of 1987; Prescrip Drug Amndmts of 1992; Polic, Requirmts and Admin Procdres 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
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