Description
We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II), collectively referred to as HTLV-I/II, by blood and blood components. These recommendations apply to the collection of Whole blood and blood components, except Source Plasma.
Scope & Applicability
Product Classes
2Product category subject to HTLV testing recommendations; blood components for transfusion or further manufacturing
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Stakeholders
4entities providing platelets for transfusion; entities responsible for platelet collection and testing; Entities responsible for initial collection and labeling of blood components.
Individuals providing blood or HCT/Ps; Individual providing blood, tissues, or organs
The receiving distributor who provides an acknowledgment letter.
requalification method for blood donors deferred
Regulatory Context
Attributes
3required legend for labeling reactive blood components
classification of implementing requalification recommendations
classification of implementing alternative requalification methods
Related CFR Sections (6)
- 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 →
- 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 →
- 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 →
See Also (8)
- Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) (Status: Final)
- Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies: Guidance for Industry (Status: Final)
- Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for Industry (Status: Final)
- Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff (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)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (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)
- Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff (Status: Final)