Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry

Description

This guidance document provides you, blood establishments that collect blood and blood components, including Source Plasma, with FDA’s recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV).  The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, including Source Plasma.

Scope & Applicability

Regulatory Context

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR606.100§ 606.100 Standard operating procedures.

  (a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of materRead full regulation →

• 21CFR630.30§ 630.30 Donation suitability requirements.

  (a) When is a donation suitable ? A donation is suitable when:Read full regulation →

• 21CFR630.40§ 630.40 Requirements for notifying deferred donors.

  (a) Notification of donors. You, an establishment that collects blood or blood components, must make reasonable attempts to notify any donor, including an autologous donor, who has been deferred based on the results of tests for evidence of infection with a relevant transfusion-transmitted infectionRead full regulation →

• 21CFR610.41§ 610.41 Donor deferral.

  (a) You, an establishment that collects human blood or blood components, must defer donors testing reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) under § 610.40(a) , from future donations of human blood and blood components, except:Read full regulation →

• 21CFR610.40§ 610.40 Test requirements.

  (a) Human blood and blood components. Except as specified in paragraphs (c) and (d) of this section, you, an establishment that collects blood and blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medicalRead full regulation →

• 21CFR630.3§ 630.3 Definitions.

  As used in this part and in part 610, subpart E, and part 640 of this chapter :Read full regulation →

• For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
• Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires: Guidance for Industry (Status: Final)
• Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for Industry (Status: Final)
• Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies: Guidance for Industry (Status: Final)
• Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion: Guidance for Industry (Status: Final)
• Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry (Status: Final)
• Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection: Guidance for Industry (Status: Final)
• Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion: Final Guidance for Industry (Status: Final)