🩸FDA Guidance on Hepatitis B Testing for Blood Donations
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availability of a draft document entitled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood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 The draft guidance, when finalized, is intended to supersede the recommendations regarding testing of all blood donations for HBsAg in the guidance document entitled "Guidance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).
Learn More🧪FDA Classifies Zika Virus Serological Reagents to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Zika virus serological reagents' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
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