Description
We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. These recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device.
Scope & Applicability
Product Classes
2The products to which the uniform container labeling standard applies.
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Stakeholders
7entities providing platelets for transfusion; entities responsible for platelet collection and testing; Entities responsible for initial collection and labeling of blood components.
Donors deferred based on screening results
entities receiving distributed blood components
FDA advisory body discussing malaria testing strategies
Each blood establishment should review its records
The receiving distributor who provides an acknowledgment letter.
establishments required to submit annual reports under 601.12
Regulatory Context
Attributes
1The state of a screening test result that triggers further testing.
Related CFR Sections (9)
- 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 →
- 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 →
- 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 →
- 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 →
- 21CFR630.35§ 630.35 Requalification of previously deferred donors.
Establishments may determine a deferred donor to be eligible as a donor of blood and blood components if, at the time of the current collection, the donor meets the eligibility criteria in this part, except for the record of the previous deferral, and you determine that the criteria that were the baRead full regulation →
- 21CFR606.160§ 606.160 Records.
- 21CFR630.30§ 630.30 Donation suitability requirements.
(a) When is a donation suitable ? A donation is suitable when: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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
Related Warning Letters (1)
- 2024-10-15
CGMP/Blood & Blood Components/Adulterated
Hemarus LLC
See Also (8)
- Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: 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, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)
- Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry (Status: Final)