Description
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry'' dated May 2010. The guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV-1 ribonucleic acid (RNA) and HCV RNA.
Scope & Applicability
Product Classes
3The products subject to NAT testing and disposition recommendations.; Products subject to quarantine and lookback; The products subject to these testing and reentry requirements.; Current Good Manufacturing Practice for Blood and Blood Components
Specific 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
7Entities to whom the recommendations in the guidance are provided.; Entities collecting Whole Blood or blood components
The party receiving the imported goods, responsible for submitting evidence.
Entity responsible for submitting NDINs
Entities performing NAT on donor samples.
Individuals providing blood or HCT/Ps; Individual providing blood, tissues, or organs
Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Entity responsible for implementing testing and deferral procedures
Regulatory Context
Attributes
7Test result status indicating presence of a marker
NAT that has the same sensitivity claims as the original NAT
Time required before treatment may begin after submission
Repeatedly Reactive test result.
A negative test result in a screening assay.
Time required before follow-up testing for HCV
Time required before follow-up testing for HIV; time required before obtaining a follow-up sample for reentry
Identified Hazards
Hazards
1period where virus is present but not detectable by antibody tests
Related CFR Sections (10)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.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 →
- 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 →
- 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 →
- 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 →
- 21CFR610.46§ 610.46 Human immunodeficiency virus (HIV) “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 →
- 21CFR606.140§ 606.140 Laboratory controls.
Laboratory control procedures shall include: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 →
- 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 →
See Also (8)
- An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry (Status: Final)
- Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry (Status: Final)
- Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry (Status: Final)
- Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Compliance Policy Guide CPG Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products (Status: Final)