AABB's Regulatory Toolkits for Members

The AABB Regulatory Affairs staff have developed these Toolkits and “Member Offerings” to equip our members with the most up-to-date, practical tools to guide you through regulatory decision-making processes.

Regulatory Update Toolkits: 2019-2020, 2021-2022, 2023-2024 (member-protected)

What's New

What’s New

Saline Supply Shortage - Resources to Consider - December 3, 2024 (open access)
Oropouche Virus Information and Resources - November 5, 2024 (member-protected)
Informing Donors of Risks, Use of Donor Information and Blood Samples, and Acknowledgement to Donate Whole Blood - October 2024 (member-protected)
User Guide for the June 2024 Circular - September 2024 (open-access)

Operational Considerations

Operational Considerations

Saline Supply Shortage - Resources to Consider - October 30, 2024 (open access)
Implementation of Cold-Stored Platelets - Toolkit - Updated December 2023 (member-protected)
Current Regulatory Options for Collections from Female Blood Donors with Hemoglobin Levels of 12.0 - <12.5 g/dL - January 28,2022 (open-access)
Blood Supply: Summary of Crucial Regulatory Options Already Available from FDA - January 20, 2022 (open-access)
COVID-19 Convalescent Plasma under Emergency Use Authorization – January 14, 2022 (open-access)
Live with FDA on the CCP Regulatory Landscape – October 28, 2020 (open-access)
Regulatory Resources for Transfusion Services (member-protected)
Transfusion Services: FDA Registration Requirements when Extending Platelet Expiration to Day-6 or Day-7 - June 23, 2021 (member-protected)

DHQs and Donor Eligibility

DHQs and Donor Eligibility

Informing Donors of Risks, Use of Donor Information and Blood Samples, and Acknowledgement to Donate Whole Blood - October 2024 (member-protected)
Blood Pressure and Pulse - Implementation of FDA's Compliance Policy Guidance (member-protected)
DHQ v4.0 Spanish Language Translation Toolkit – Examples to Consider - August 2023 (member-protected)
IDA and DHQ v4.0 and Accompanying Materials - Toolkit for Implementation - August 2023 (open-access)

Infectious Diseases

Infectious Disease Risk and Testing

Oropouche Virus Information and Resources - November 5, 2024 (member-protected)
Resources to Support FDA's Determination that ZIKV is No Longer an RCDAD (member-protected)
Resources to Support FDA's Voluntary TB Risk Mitigation Strategies for HCT/P Establishments and Transfusion Services - Updated March 14, 2024 (open-access)
Mpox Resources to Consider – February 2024 (open-access)
HCV Testing, Lookback and Reentry – June 21, 2022 (member-protected)
HIV Testing, Lookback and Reentry - October 17, 2021 (member-protected)
Syphilis Guidance Toolkit - December 9, 2020 (member-protected)
HCV Further Testing Toolkit – November 2019 (member-protected)
Ebola Toolkit - May 2020 (member-protected)
Babesia Toolkit – September 2019 (member-protected)

Circular of Information & Labeling

Circular of Information & Labeling

User Guide for the June 2024 Circular – September 2024 (open-access)
AABB Checklist for Historic Antigen Labeling – January 2019 (member-protected)

Licensure & BLA Submission

Licensure & BLA Submission

Licensed COVID-19 Convalescent Plasma - July 29, 2024 (member-protected)
BLA Checklist for Plasma Collected by Apheresis – March 25, 2024 (member-protected)
BLA Checklist for RBCs Collected by Apheresis – March 25, 2024 (member-protected)
BLA Checklist for Platelets, Leukocytes Reduced Collected by Apheresis – March 25, 2024 (member-protected)

Related News

New AABB Resources Summarize Upcoming Changes to CLIA Regulations

December 18, 2024
FDA Workshop to Focus on Generating Scientific Evidence to Facilitate CT Development

December 18, 2024
AABB and ARC Submit Comments to Support Manufacture of Platelets by Buffy Coat Method

December 18, 2024