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America's Blood Centers
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October 2, 2025

Blood Community Letter to FDA in Response to Draft Guidance on Hepatitis B Testing for Blood Donations

By America's Blood Centers

America’s Blood Centers, AABB, and the American Red Cross submitted this comment letter to the FDA regarding proposed changes to hepatitis B testing requirements for blood donations in response to draft FDA guidance that would eliminate the need to test blood donations for hepatitis B surface antigen (HBsAg) when nucleic acid testing (NAT) for HBV DNA and antibody testing for hepatitis B core antigen (anti-HBc) are performed.

While supportive of this change for whole blood donations, the organizations argue that HBsAg testing should also be eliminated for Source Plasma donations used in manufacturing plasma-derived medicinal products. They make clear that HBV NAT testing combined with viral inactivation/removal steps in the manufacturing process is sufficient to ensure safety without HBsAg testing. The letter requests that the FDA recognize this for all plasma used in manufacturing, not just recovered plasma, to create regulatory consistency and facilitate international harmonization of testing requirements.

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  • About Us
    • About
    • Leadership
    • Committees
    • Partners
      • Stop the Bleed National Partnership
      • National Partnerships User Guide
    • ABC Strategic Plan
    • Foundation
    • Career Center
    • Membership Directory
    • Women’s Executive Leadership Community
    • Executive Fellows Program
    • Corporate Partner Council
    • ADRP
  • Advocacy
    • Advocacy Agenda
    • Priorities
      • Strengthening the Cyber Resilience of the Blood Community
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
      • Diversifying the Donor Base
      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
    • Act for Blood
    • State-Based Advocacy
      • Map of State Legislation
      • Legislation We’re Watching
    • Blood Advocacy Week
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    • All Latest News
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    • U.S. Blood Donation Statistics and Public Messaging Guide
    • Vein to Vein: The Science of Blood Donation
    • A Vital Resource
    • Blood Centers Career Video
    • ABC Benchmark Surveys
    • The Value of Blood
    • Advertise
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