Description
We, FDA, are providing you, blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes, with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). We are also providing you with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling.
Scope & Applicability
Product Classes
3Blood component subject to the recommendations in this guidance
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component intended for further manufacture
Stakeholders
5Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Establishments requiring FDA acceptance of methods before implementation
required to report changes to an approved biologics license application
use a registered contract donor testing laboratory
Potential HCT/P donor screening
Regulatory Context
Attributes
3A test result status for HBsAg that triggers further action or neutralization testing.
Status of individuals with HBV or HCV infection
sample is Non-Discriminated Reactive
Identified Hazards
Hazards
2The public health risk that NAT screening is intended to reduce.
Residual risk of infection from blood transfusion
Related CFR Sections (5)
- 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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR606.121§ 606.121 Container label.
(a) The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components intended for use in transfusion or further manufacture by all blood establishments.Read full regulation →
- 21CFR606.122§ 606.122 Circular of information.
A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:Read 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 →
See Also (8)
- 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)
- 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)
- Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for Industry (Status: Final)
- Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry (Status: Final)
- Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry (Status: Draft)
- 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)
- Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry (Status: Final)