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, 2025-2026 (member-protected)

What's New

What's New

Blood Resiliency During Cybersecurity Events - April 2025 (open access)
Implementation of FDA's Recommendations to Reduce the Risk of Mtb and Sepsis by HCT/Ps (member-protected)
Laboratory Developed Tests - Final Rule - Stage 1 Phaseout - January 13, 2025 (member-protected)
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)

Operational Considerations

Operational Considerations

Blood Resiliency During Cybersecurity Events - April 2025 (open access)
Laboratory Developed Tests - Final Rule - Stage 1 Phaseout - January 13, 2025 (member-protected)
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

Implementation of FDA's Recommendations to Reduce the Risk of Mtb and Sepsis by HCT/Ps (member-protected)
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)
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

REGULATORY UPDATE: New AABB-BCA Toolkit Focuses on Shared Manufacturing as a Cybersecurity Strategy

April 09, 2025
REGULATORY UPDATE: AABB, ABC and ARC Ask FDA to Reconsider HTLV-I/II Testing Recommendations

April 09, 2025
REGULATORY UPDATE: AABB, ABC and ARC Submit Comments to FDA on Mtb and Sepsis Guidances

April 08, 2025