REGULATORY UPDATE: New AABB-BCA Toolkit Focuses on Shared Manufacturing as a Cybersecurity Strategy
April 09, 2025
AABB and Blood Centers of America (BCA) released a
joint toolkit on Wednesday to support blood collection facilities in maintaining operational continuity and protecting patient access to transfusion services during cybersecurity incidents. The toolkit outlines how blood centers can implement shared manufacturing arrangements in alignment with the Food and Drug Administration’s current regulatory framework.
Shared manufacturing offers a practical, flexible strategy for licensed blood centers to support one another during disruptions by leveraging flexible licensing arrangements. The approach is designed to bolster resiliency, sustain blood availability and minimize patient risk when electronic systems are compromised.
The toolkit includes an overview of FDA’s regulatory considerations and applicable guidance, key factors for facilities to evaluate when assessing whether shared manufacturing is suitable for their operations, and next steps for implementation, including resources to support compliance with FDA requirements.
“Recent cyberattacks on blood centers have highlighted the urgent need for preparedness strategies to protect the nation’s blood supply,” said Delisa English, president and CEO of The Blood Connection, chair of the BCA Board of Directors, and secretary of the AABB Board of Directors. “Shared manufacturing offers a critical solution to these challenges, and this joint toolkit is a valuable resource for those in the field who face the ongoing challenges created when cyberattacks occur.”
AABB and BCA encourage centers to review the full toolkit and assess whether a shared manufacturing arrangement could meet their operational needs. Facilities with questions should contact the FDA’s Center for Biologics Evaluation and Research at
CBEROBRRBPBInquiries@fda.hhs.gov.
