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FDA CBER issues recommendations on managing donors and units initially reactive for HBsAg

🇺🇸 FDA CBER · Mon 02 Nov 2026

CBER's recommendations describe how blood establishments may reevaluate donors who are initially reactive for hepatitis B surface antigen, provided other suitability requirements are met.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has issued recommendations on the management of donors and blood units that are initially reactive for hepatitis B surface antigen (HBsAg). The item is dated 2 November 2026.

According to the information available, the recommendations set out procedures under which a donor who is initially reactive for HBsAg may be reevaluated by a blood establishment. Reevaluation is conditional on the donor meeting all other donor suitability requirements.

The recommendations also cover how initially reactive donors and units are handled, and whether donors may be reinstated. The full text of the document was not available at the time of writing, so details of the testing steps, timelines and documentation expectations are not reported here.

By way of general context, FDA recommendations of this kind are non-binding guidance that describes the agency's current thinking. Establishments may use alternative approaches if they satisfy the applicable regulatory requirements.

What it means for your team

  • Blood establishment QA teams should review the full CBER document against current standard operating procedures for handling initially reactive HBsAg results.
  • Donor management and reinstatement procedures may need checking to confirm they align with the reevaluation pathway described.
  • Teams should confirm how the recommendations apply to unit disposition and record-keeping once the full text has been read.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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