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FDA Accepts New Language For “Circular of Information for the Use of Human Blood and Blood Components”

Heartland Blood Center – November 3, 2017

AABB has updated its “Circular of Information for the Use of Human Blood and Blood Components” web page following the FDA’s approval for new language to be inserted in the November 2013 Circular. The updates have been made to provide the approved statement regarding the newly licensed Zika virus (ZIKV) nucleic acid test (NAT). The updated language is intended for use with blood products that have been tested for ZIKV using an FDA-licensed test. In such cases, the FDA requires the insertion of the following language:

  • “A licensed nucleic acid test (NAT) for Zika Virus RNA has been performed and found to be nonreactive.”

This language, developed by the Circular of Information Task Force and accepted by FDA, is similar to that required for other licensed NAT tests.

The insertion of this language is not required for blood products that have been tested for ZIKV under an Investigational New Drug (IND). In such cases, language provided by the IND sponsor remains unchanged.
AABB recommends the use of an adhesive label or an ink stamp to insert the updated language into the Circular. In addition, the version date of November 2013 will not change with this language insertion.

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