Cliff

Docket Number: FDA-1997-D-0029 Issued by: Center for Devices and Radiological Health Center for Biologics Evaluation and Research This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

Guidance for Autologous Blood and Blood Components

Handling of Human Blood Source Materials

HTLV-I Antibody Testing

Human Plasma Collected by Plasmapheresis

Docket Number: FDA-2016-D-1342 Issued by: Center for Biologics Evaluation and Research This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 4.0 dated May 2023, prepared by the AABB Donor History Task Force .  This guidance also provides recommendations to licensed establishments on how to report implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). 

Docket Number: FDA-2016-D-1342 Issued by: Center for Biologics Evaluation and Research This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 3.0 dated June 2023, prepared by the Plasma Protein Therapeutics Association (PPTA).   This guidance also advises Source Plasma manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).
The SPDHQ documents provide establishments that collect Source Plasma with a specific process for administering questions to donors to determine their eligibility to donate.  Acceptable SPDHQ documents are those documents that FDA has determined provide Source Plasma collection establishments with one means of obtaining donor history information to determine if a donor is eligible, consistent with FDA requirements and recommendations.  The SPDHQ documents have been updated to align with FDA’s current requirements and recommendations for donor eligibility. 
This guidance supersedes the document entitled “Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma” dated May 2020.

Docket Number: 2005D-0362 Issued by: Center for Biologics Evaluation and Research Source Plasma manufacturers might want to implement a collection program to collect Source Plasma from donors who have detectable levels of disease-associated Immunoglobulin G (IgG) antibodies and other existing IgG antibodies (see section IV). Such disease-associated IgG antibodies are antibodies that have occurred in response to exposure to disease agents or other antigens. This guidance is intended to assist you, a Source Plasma manufacturer, in submitting the appropriate information to FDA when implementing an IgG antibody collection program or when adding a new IgG antibody collection to your existing program. This guidance finalizes the draft guidance entitled “Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies” dated October 2005 (70 FR 61135; October 20, 2005), and replaces the draft Reviewers’ Guide, “Disease Associated Antibody Collection Program,” issued October 1, 1995.

Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection
Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
FDA requires blood establishments to test blood donations for new or emerging infectious agents that may affect blood product safety if certain conditions outlined in FDA regulations are met.  Specifically, if a transfusion-transmitted infection “may have sufficient incidence and/or prevalence to affect the potential donor population” and meets certain other criteria described in FDA’s regulations, then FDA may determine the transfusion-transmitted infection is a “relevant transfusion-transmitted infection” (RTTI).  Testing for an RTTI is required under FDA’s regulations if FDA-licensed, approved, or cleared screening tests are available and testing is necessary to reduce adequately and appropriately the risk of transmission.  
FDA has determined Zika virus (ZIKV) is no longer an RTTI under FDA’s regulations because, as discussed further below, the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population.  Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018.  Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV.  Licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. Corresponding changes to the circular of information must also be reported in the annual report under 21 CFR 601.12(d)

Docket Number: 2006D-0108 Issued by: Center for Biologics Evaluation and Research This guidance provides recommendations to you, a blood establishment, for obtaining written informed consent from a prospective Source Plasma donor participating in a plasmapheresis program or an immunization program. In this guidance, we, FDA, provide recommendations on how to satisfy the requirements for informed consent under 21 Code of Federal Regulations (CFR) 640.61─Informed consent, as they relate to plasmapheresis and immunization programs.This guidance is intended to assist you in planning and applying for your original Biologics License Application (BLA) or in supplementing your existing BLA regarding your informed consent procedures and documents.

Inspections of Military Blood Establishments, Revised Instructions for Command Notification

Docket Number: FDA-2020-D-1825 Issued by: Center for Biologics Evaluation and Research FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to emerging threats. 
On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  FDA subsequently reissued this EUA with revisions.  Most recently, FDA revised the EUA to limit authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting.   FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND).  For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma.  The guidance also provides recommendations to blood establishments on collection.  This document supersedes the guidance of the same title issued in January 2022 (previous versions February 2021, January 2021, November 2020, September 2020, May 2020, and April 2020).  The recommendations in this guidance are unchanged from the January 2022 guidance.  However, we have removed the language limiting the duration of the policy in the guidance to the public health emergency related to COVID-19 declared by HHS in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)), which expired on May 11, 2023.

Docket Number: FDA-2016-D-4308 Issued by: Center for Biologics Evaluation and Research We, FDA, are issuing this guidance document to provide you, establishments that collect blood and blood components for transfusion, with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). This guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. This guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12. This guidance does not apply to test results for ABO and Rh(D) antigens. For ABO and Rh(D) antigens, you must follow FDA requirements in 21 CFR 640.5(b) and (c), and 606.121(c)(9) and (13), as well as all other applicable requirements.

Management of Blood Establishment Submissions

Docket Number: FDA-2017-D-6784 Issued by: Center for Biologics Evaluation and Research We, FDA, are providing you, blood establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components.  We have received specific questions from blood establishments who have chosen to use the INTERCEPT® Blood System for Platelets and Plasma and who have questions on implementation of this pathogen reduction device.  As a result, we are providing guidance in a question and answer format, addressing the most frequently asked questions.

Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT)

Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma

Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

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

Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen

Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices

Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk