Description
We, the Food and Drug Administration (FDA), are providing you, blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV), as required under 21 CFR 610.40(e). We are also providing guidance to blood establishments on how to report the implementation of these recommendations.
Scope & Applicability
Product Classes
2Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component subject to the recommendations in this guidance
Stakeholders
1Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Regulatory Context
Attributes
1The state of a screening test result that triggers further testing.
Related CFR Sections (5)
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR606.65§ 606.65 Supplies and reagents.
All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.Read full regulation →
- 21CFR610.47§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
(a) If you are an establishment that collects Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions: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 →
- 21CFR610.40§ 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 →
See Also (8)
- 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)
- 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)
- Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application: 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)