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Docket Number: FDA-2003-D-0128 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood establishments that collect Whole Blood or blood components, including Source Plasma, with recommendations for screening and testing of donors and management of donations based on screening tests for syphilis.  Syphilis is a relevant transfusion-transmitted infection (Title 21 Code of Federal Regulations (CFR) 630.3 (h)(1)(v)).  Licensed blood establishments must report the implementation of the recommendations contained in this guidance in accordance with 21 CFR 601.12.  
This guidance updates the guidance of the same title dated September 2014.  The September 2014 guidance finalized the draft guidance of the same title dated March 2013, and superseded the memorandum dated December 12, 1991, entitled “Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.”

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment. 
Furthermore, a blood establishment may adopt more stringent procedures, provided they are. consistent with these recommendations. At each step in this procedure, the predominance of each test and the interpretation of results should be as specified, in the package insert for that kit.
 

Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits recommendations regarding license amendments and procedures pertinent to irradiated blood and blood products. Irradiation of these products is a practice which has developed over many years to reduce the risk of transfusion-­associated graft-versus-host disease in recipients at this complication.
Since labeling of blood and blood products as irradiated pertains to safety and intended use, irradiated and non-irradiated products are considered different products by the Center for Biologics Evaluation and Research. Recommendations are provided here regarding manufacturing and quality control procedures, labeling and other aspects of production and use of irradiated blood and blood products.

Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

Docket Number: FDA-2012-D-0307 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.  The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.  
This guidance supersedes the guidance of the same title dated April 2020 and updated August 2020 (2020 guidance).  We removed the recommendations to defer indefinitely blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom (U.K.) from 1980-1996 and for time spent in France and Ireland from 1980-2001, and 2) receipt of a blood transfusion in the U.K., France, and Ireland from 1980-present.  We also provide recommendations for requalification of individuals previously deferred for these geographic risk factors, provided they meet all other eligibility requirements.

Docket Number: FDA-2000-D-0187 Issued by: Center for Biologics Evaluation and Research This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM).  The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma.  Blood establishments are not required to assess Source Plasma donors for malaria risk (21 CFR 630.15(b)(8)).  This guidance supersedes the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance).  
To address the urgent and immediate need for blood and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 FDA (we) issued revised recommendations to reduce the risk of TTM during the public health emergency.  The recommendations in the April 2020 guidance were based on the Agency’s evaluation of the available scientific and epidemiological data on malaria risk, and data on FDA-approved pathogen reduction devices.  As stated in the April 2020 guidance, FDA expected implementation of the revised recommendations would not be associated with any adverse effect on the safety of the blood supply and that early implementation of the recommendations may help to address significant blood shortages that occurred as a result of the COVID-19 public health emergency.  Further, the guidance explained that we expected that the recommendations set forth in the revised guidance would continue to apply outside the context of the COVID-19 public health emergency, and that FDA would replace the April 2020 guidance with an updated guidance that incorporates any appropriate changes based on public comments and our experience with implementation.

Reduction of the Maximum Platelet Storage Period tp 5 Days in an Approved Container

Docket Number: FDA-2008-D-0263 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion, with recommendations for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) were falsely positive and that there is no evidence of infection with hepatitis B virus (HBV). Currently, donors who are repeatedly reactive on more than one occasion for anti-HBc (samples from more than one collection from the same donor are repeatedly reactive for anti-HBc) must be indefinitely deferred in accordance with Title 21 Code of Federal Regulations, section 610.41(a) (21 CFR 610.41(a)).

Docket Number: FDA-2008-D-0263 Issued by: Center for Biologics Evaluation and Research This guidance document is intended for blood establishments that manufacture Whole Blood and blood components for transfusion or for further manufacture, including Source Plasma and Source Leucocytes. This guidance provides recommendations for a requalification method or process for the reentry of deferred donors who test repeatedly reactive for hepatitis B surface antigen (HBsAg), confirmed positive by neutralization, following a recent vaccination against hepatitis B virus (HBV) infection, and who are not infected by HBV.

Docket Number: FDA-2017-D-5152 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion or for further manufacture, including Source Plasma and Source Leukocytes, with recommendations for a requalification method under Title 21 of the Code of Federal Regulations (CFR) 630.35(b) (21 CFR 630.35(b)) for donors who had been indefinitely deferred for a history of viral hepatitis after the 11th birthday, prior to the elimination of the donor suitability requirement under 21 CFR 640.3(c)(1) and 21 CFR 640.63(c)(11).

Requirements for Computerization of Blood Establishments

Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components

Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software

Revised Guidelines for the Collection of Platelets, Pheresis

Docket Number: FDA-2013-S-0611 Issued by: Center for Biologics Evaluation and Research On August 14, 1974, the Food and Drug Administration (FDA) issued a guideline recommending immunization schedules for Source Plasma donors participating in red blood cell immunization programs. FDA revised the guideline in June, 1980, with additional recommendations concerning red blood cell donor criteria, volume and frequency of collections, laboratory tests, preparation of antigen, and record keeping.
Subsequently, the Center for ·Biologics Evaluation and Research (CBER) , FDA, issued a memorandum on October 7, 1988, entitled "Recommendations for Changeover from Use of Fresh Immunizing Red Blood Cells to Use of Frozen Immunizing Cells Stored a Minimum of Six Months Prior to Use" . This memorandum recommended the use of immunizing red blood cells stored for a minimum of six months prior to use to permit re-testing of red blood cell donors for infectious diseases, including anti-HIV, HBsAg, anti-HBc, and alanine aminotransferase (ALT) testing.

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, April 1992. These recommendations supersede those issued on 29 November 1990 which should be archived.
 

Docket Number: FDA-2013-S-0612 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Revised Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, August, 1993. These revised recommendations modify those issued on April 23, 1992, in regard to testing for anti-HCV. A donor who currently tests, or who in the past had tested, repeatedly reactive for anti-HCV with a solid phase enzyme linked immunoassay (ELISA), licensed by the Food and Drug Administration (FDA), may now be considered for re-entry provided that certain criteria, described in this document, are fulfilled.

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products

Docket Number: 99D-2213 Issued by: Center for Biologics Evaluation and Research To reduce infectious disease transmission by blood and blood products, donor samples from blood donations are tested for markers of pathogenic bloodborne infections, including antibodies, antigens, and nucleic acids that may indicate the presence of etiologic agents such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphotropic virus (HTLV), cytomegalovirus (CMV), syphilis, and others. The validity of screening and supplemental (confirmatory) test assay results is determined by the performance of test kit manufacturer supplied reagents labeled as Acontrols@, used in accordance with the test kit instructions.

Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs

Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)