REGULATORY UPDATE: New AABB Toolkit Outlines Implementation Options for FDA’s May 2022 CJD/vCJD Guidance

AABB has developed a toolkit of options for implementation of the Food and Drug Administration’s May 2022 Creutzfeldt-Jakob Disease (CJD) and variant CJD guidance. The May 2022 guidance supersedes the April 2020 and updated August 2020 guidance of the same title. Because the final guidance removes requirements and does not add requirements, there is flexibility to use less burdensome options and remain in compliance with FDA’s expectations.

Until the less restrictive recommendations of the guidance can be incorporated into the next version of the Donor History Questionnaire (DHQ v3.0) and formally reviewed by FDA , the toolkit offers three options for consideration:

• Option 1: Retain current DHQ v2.1 without changes in deferral policy because DHQ v2.1 meets or exceeds the requirements in the May 2022 CJD/vCJD guidance.
• Option 2: Retain current DHQ v2.1 with changes in deferral policy because DHQ v2.1 meets or exceeds the requirements in the May 2022 CJD/vCJD guidance.
• Option 3:Option 3: Develop a new DHQ for FDA submission. A donor center may elect to update its DHQ and its BECS before DHQ v3.0 is available.

This organized and easy-to-follow toolkit provides background information in a question-and-answer format, followed by the three options for implementation, including example flowcharts. Each option for full compliance comes with a checklist and provides the needed flexibility for each blood collection facility to determine its next steps. Contact regulatory@aabb.org with questions.