🩸FDA Guidance on Hepatitis B Testing for Blood Donations
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV). The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The draft guidance, when finalized, is intended to supersede the recommendations regarding testing of all blood donations for HBsAg in the guidance document entitled "Guidance for Industry: 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" dated October 2012 (October 2012 Guidance). The guidance, when finalized, will also supersede information on the same topic that is in the document entitled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" dated December 1987 (December 1987 Memorandum).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines the FDA's draft guidance for testing blood donations for hepatitis B surface antigen, which affects blood establishments. Compliance with new testing recommendations is essential to mitigate the risk of transfusion-transmitted hepatitis B virus, implicating operational and regulatory requirements for blood collection businesses.