This webpage provides the background information for compliance with FDA requirements for a Circular of Information (the
Circular), including purchase, implementation, and updated language. AABB encourages you to review the information for important changes.
Please visit the
AABB Marketplace to order the new Circular of Information for the Use of Human Blood and Blood Components, dated October 2017, as a
brochure/electronic bundle. It can also be
viewed as a pdf document but
not copied or printed.
Please contact Regulatory Affairs with your questions at
Proper Use of the
The AABB Circular of Information Task Force (the AABB Task Force) developed the
Circular to assist blood manufacturers with this extension of container labeling. The
Q&A document and NEW INFORMATION/GUIDELINES FOR USE OF THE CIRCULAR will guide you through your responsibilities for proper use of the
Circular, including answers to the following questions:
Does FDA require a circular of information? And if so, why?
Who is responsible for making the
Is each blood collection establishment required to develop a circular?
How does FDA formally accept the AABB
What is the current version of the
Is there an electronic version of the
Circular that is acceptable to use?
What are the changes in the October 2017
Are there guidelines for use of the
December 2017 guidance, FDA describes options for compliance with the requirements of
21 CFR 601.12. In Section IV, Implementation, FDA states:
“Licensed manufacturers must report the implementation of the October 2017 Circular to FDA under 21 CFR 601.12 as follows:
- If the October 2017 Circular is implemented without modification and in its entirety, the change is considered to be minor. You must report such changes to FDA in your annual report, consistent with 21 CFR 601.12(f)(3) and noting the date the process was implemented.
- If the October 2017 Circular is implemented with modification, the change is considered to be major. You must report such changes as a Prior Approval Supplement, consistent with 21 CFR 601.12(f)(1).”
FDA REQUIRED UPDATES to the
Concerning ZIKV Testing Language in the
The October 2017
Circular was printed before a licensed ZIKV NAT test system was approved by FDA. Therefore, the
Circular does not address ZIKV testing. As of the date FDA posted the December 2017 guidance, testing for ZIKV is performed using an investigational test or a licensed test and both require the addition of language to update the
Language for testing using the FDA licensed ZIKV NAT:
The October 2017
Circular was printed before the FDA licensed a ZIKV NAT making it necessary to update the language for those using the newly licensed test. Refer to the
November 02, 2017 News Flash (sent to all AABB members and accreditation contacts) for more information.
Testing for ZIKV using an FDA licensed test:
The following language, developed by the AABB Task Force and accepted by FDA, is similar to that used for other licensed NAT tests that are required. This language must be added to the
Circular until it can be incorporated in a future version: “A licensed nucleic acid test (NAT) for Zika Virus RNA has been performed and found to be nonreactive.”
Language for use with an investigational test for ZIKV (under IND): The required update for facilities that continue to test for ZIKV under IND remains unchanged.
Testing for ZIKV using an investigational test:
The additional language for testing under IND
will continue as provided by the IND sponsor. As clarified by FDA representatives during the
2016 Ask the FDA session at AABB’s Annual Meeting, blood collectors must update their
Circular regarding testing for ZIKV using the language provided by their IND sponsor. This change to the
Circular is reported as a minor change in your annual report because the language in the IND has already been reviewed and approved by FDA. This information continues to apply to ZIKV testing under IND.
Consistent with historic practices:
- AABB suggests using an adhesive label or an ink stamp to insert additional language into the
- The version date of October 2017 for the
Circular should not be changed.
- Contact your Consumer Safety Officer if you are planning to add additional language.
- You must select the appropriate option for ZIKV NAT testing language based on testing for ZIKV performed under IND
or performed using an FDA licensed test.
- For the period of time your inventory includes components tested by a licensed ZIKV test and others tested using an investigational test for ZIKV, you should add language for both to ensure the
Circular, as extension of labeling, accurately reflects your practice and operations. This also applies to imported components that you distribute.