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# Guidance on Hepatitis B Tests for HCT/P Donors
- URL: https://www.fdaweb.com/guidance-on-hepatitis-b-tests-for-hct-p-donors/
- Published: 2016-01-08T12:00:00.000Z
- Updated: 2026-09-15T02:26:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134380

*Federal Register* Notice: FDA is making available a draft document entitled *Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry*. It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests in donor testing for hepatitis B virus deoxyribonucleic acid. When finalized, it is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen and total antibody to hepatitis B core antigen, in the document entitled *Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)* dated 8/2007\. To download this draft guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM480606.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-08/pdf/2016-149.pdf?ref=fdaweb.com)