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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, Timeframe for Licensing Irradiated Blood Products

Issued by: Center for Drug Evaluation and Research        Center for Biologics Evaluation and Research This guidance is intended to provide recommendations to sponsors and applicants on the use of monoclonal antibodies (mAbs) as reagents in the manufacture of drug substances that are regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), supplements to these applications, or investigational new drug applications (INDs).

Nomenclature for Monoclonal Blood Grouping Reagents

Docket Number: 2002D-0124 Issued by: Center for Biologics Evaluation and Research This document’s goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER).  This guidance updates the guidance of the same title dated September 2003.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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

Docket Number: FDA-2008-D-0379 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to FDA implementation of parvovirus B19 NAT.

Physician Substitutes (Update)

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research In an April 1, 1983, Notice published in the Federal Register (Vol. 48, No. 64, page 14048), the Food and Drug Administration (FDA) advised that plasma derived from therapeutic exchange procedures is a biological product subject to the licensing provisions of the Public Health Service Act [42 USC 262 (a)] then collected and shipped for further manufacture into in vitro diagnostic products.

Plasma Derived from Therapeutic Plasma Exchange

Docket Number: FDA-2001-D-0254 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, blood establishments, with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. We also provide information to licensed blood establishments for submitting biologics license application supplements to include leukocytes reduced components. This guidance applies to Whole Blood, Red Blood Cells, Plasma, and Platelets1  manufactured from Whole Blood or collected by automated methods2 . This guidance document finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled "Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products."

Docket Number: FDA-2022-D-0484 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.

Docket Number: FDA-2007-D-0251 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in the premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for empty containers for the collection and processing of blood and blood components used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.

Docket Number: FDA-2022-D-0485 Issued by: Center for Biologics Evaluation and Research This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.

Recipient Serum Samples

Docket Number: FDA-1998-D-0067 Issued by: Center for Biologics Evaluation and Research We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable for use by you, manufacturers of blood and blood components, subject to United States statutes and regulations, the document entitled "United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128," Version 3.0.0, dated March 2013 (Version 3.0.0 Standard). The Version 3.0.0 Standard is the revised version of the "United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128," Version 2.0.0, dated November 2005 (the Version 2.0.0 Standard).

Docket Number: FDA-2014-D-2175 Issued by: Center for Biologics Evaluation and Research We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. This guidance document applies to Ebola virus (species Zaire ebolavirus).1 The recommendations in section III. of this guidance document apply to the routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The collection of convalescent plasma from EVD survivors is addressed in section V. of this guidance document. This guidance finalizes the draft guidance entitled, “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,” dated December 2015.

Docket Number: 01D-0545 Issued by: Center for Biologics Evaluation and Research This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and product safety for donors potentially exposed to Bacillus anthracis, the agent of anthrax. This guidance applies to Whole Blood, blood components (including recovered plasma) and Source Plasma collections intended for use in transfusion or for further manufacturing into injectable products. FDA developed the recommendations in this guidance in consultation with other Public Health Service Agencies and with the Blood Safety Committee of the Department of Health and Human Services.

Docket Number: FDA-2009-D-0533 Issued by: Center for Biologics Evaluation and Research In November 2009, we, FDA, issued a draft guidance entitled "Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus", dated November 2009 (Pandemic (H1N1) 2009 Virus Draft Guidance) (November 19, 2009, 74 FR 59982). This guidance finalizes that draft guidance. Note that while the recommendations that FDA is finalizing were proposed in the Pandemic (H1N1) 2009 Virus Draft Guidance, the finalized recommendations are applicable regardless of the existence of a pandemic or other emergency situation.

Docket Number: 98D-0545 Issued by: Center for Biologics Evaluation and Research This guidance document provides the recommendations of the Food and Drug Administration (FDA) for the use of FDA cleared automated blood cell separators in blood establishments for collecting single and double units of Red Blood Cells (RBC). This guidance also describes the information to be included in a license application or supplement. This final guidance document finalizes the draft guidance document entitled "Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods, dated July 1998."

Docket Number: 02D-0362 Issued by: Center for Biologics Evaluation and Research This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and quarantine and retrieval of blood and blood products in cases of donors exposed to vaccinia virus, which is the virus used in smallpox vaccines. The presence of vaccinia virus in transfused blood or plasma could be harmful to some recipients. Although the presence of vaccinia virus in blood (viremia) has rarely been documented, this possibility has not been assessed using modern laboratory techniques. Therefore, the risk of transmission of vaccinia virus by blood and blood products is uncertain.

Docket Number: FDA-2022-D-0499 Issued by: Center for Biologics Evaluation and Research On August 8, 1995, FDA issued a memorandum to all registered blood and plasma establishments entitled, "Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen". This memorandum supplements that memorandum and provides additional recommendations regarding storage of samples for HIV-1 antigen testing as well as clarifications of the previous recommendations regarding specific implementation issues. 

Docket Number: FDA-2015-D-1211 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide recommendations for evaluating donor eligibility using individual risk-based questions.  This guidance provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.  We also recommend that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures.  This guidance supersedes the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” dated April 2020, updated August 2020 (April 2020 guidance).  The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.

Recommendations for Implementation of Computerization in Blood Establishments

Docket Number: FDA-2018-D-2478 Issued by: Center for Biologics Evaluation and Research We, the Food and Drug Administration (FDA), are notifying you, blood establishments that collect blood and blood components, that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) under 21 CFR 630.3(h)(2).1 Accordingly, we are providing recommendations for donor screening, donation testing, donor deferral and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in this guidance apply to the collection of blood and blood components, except Source Plasma.2
This guidance finalizes the draft guidance of the same title dated July 2018.