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Vaccines, Blood & Biologics
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Blood Proposed & Final Rules
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Blood Proposed & Final Rules
- 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 - Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment
2/8/2008 - Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period
1/11/2008 - Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
11/30/2007 - Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
11/8/2007 - 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 - 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 - 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 - 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 - 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; Companion to Direct Final Rule
12/12/2000 - 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 - Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification
8/19/1999 - Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule
8/19/1999 - Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
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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