Bulletin 16-14

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FDA Issues Final Guidance Document for Use of HBV NAT

Bulletin 16-14

August 17, 2016

Today, the Food and Drug Administration (FDA) published a notice of availability of a Final Guidance Document that recommends use of an FDA-licensed nucleic acid test (NAT) for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) when testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Performing HBV NAT is recommended in addition to use of licensed tests for HBsAg and total anti-HBc (IgG and IgM) when testing donors of HCT/Ps for evidence of infection with HBV. The notice can be accessed here and the guidance document can be downloaded at this link:

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; Guidance for Industry (PDF - 67KB)

FDA recommends implementation of this guidance within six months after today and it applies to all HCT/Ps recovered on or after the implementation date, however, with few exclusions, HBV NAT becomes a required test for tissue donors by January 1, 2017 per changes made to the 14th edition of AATB's Standards for Tissue Banking. Refer to the AATB News Release dated July 18, 2016 and see the update to standard D4.230 Required Infectious Disease Tests.

Contact Scott Brubaker if you have any questions.