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Regulatory Updates

​This section serves as a quick reference for regulatory updates announced in AABB Weekly Report. If you have questions, please contact the Regulatory Affairs Staff at

AABB Accepting Questions for ‘Ask the FDA’ Session at the 2019 Annual Meeting – 06/21/19

REGULATORY UPDATE: FDA Issues Draft Guidance on Biotin Interference – 06/21/19

REGULATORY UPDATE: Medication Deferral List Updated – 06/14/19

REGULATORY UPDATE: CDC Publishes Report on Sepsis Attributed to Bacterial Contamination of Platelets – 06/14/19

REGULATORY UPDATE: AABB FDA Liaison Meeting Summary Available – 06/14/19

REGULATORY UPDATE: 2019 Spring Unified Agenda Published – 06/07/19

REGULATORY UPDATE: New Variance Approval under 21 CFR 640.120 – 06/07/19

REGULATORY UPDATE: FDA Issues Recall of Beckman Coulter Analyzers Related to Erroneous Platelet Counts – 05/24/19

REGULATORY UPDATE: FDA Issues Final Babesia Guidance – 05/10/19

FDA Releases 2017 Report on Fatalities Following Blood Collection and Transfusion – 05/10/19

REGULATORY UPDATE: FDA Approves Exception to Malaria Travel Deferral for Certain Collections – 04/26/19

REGULATORY UPDATE: FDA Issues Important Information on Recent Reports of Septic Transfusion Reactions Related to Acinetobacter Contamination of Platelets – 04/19/19

Ebola Virus Update – 04/19/19

REGULATORY UPDATE: FDA Posts Final Materials and Webcast of March 2019 BPAC Meeting – 04/05/19

REGULATORY UPDATE: Changes in Inspection Regulations Effective May 2019 – 04/05/19

REGULATORY UPDATE: AABB Posts Summary of Recent BPAC Meeting – 03/29/19

REGULATORY UPDATE: FDA Issues Statement on Pathogen Reduction Technologies – 03/29/19

FDA Releases Guidance Document, “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” – 03/29/19

BPAC Considers Future Approaches for ZIKV Testing and MSM Deferral Policies – 03/22/19

REGULATORY UPDATE: Joint Comments Submitted on Bacterial Risk Control Draft Guidance – 03/15/19

REGULATORY UPDATE: FDA Will Revisit ZIKV Testing Requirements and MSM Deferral Policies – 03/08/19

REGULATORY UPDATE: CBER Publishes Updated 21 CFR 640.120 Approvals – 03/08/19

REGULATORY UPDATE: FDA Issues Statement of Caution for Infusion of Young Donor Plasma – 03/01/19

Consolidated Appropriations Act, 2019 Requires FDA to Finalize Guidance on Bacterial Risk Control Strategies – 03/01/19

REGULATORY UPDATE: CBER Publishes 2019 Guidance Agenda – 03/01/19

REGULATORY UPDATE: FDA Announces Upcoming BPAC Meeting – 02/15/19

AABB Releases Ebola Toolkit as Exclusive Member Offering – 02/15/19

REGULATORY UPDATE: FDA Approves Grifols Procleix Babesia Assay – 02/08/19

Checklist for Historic Antigen Labeling Now Available as Exclusive Member Offering – 01/18/19

REGULATORY UPDATE: Health Care Worker Monitored for Possible Ebola Exposure - 01/11/19

Ebola Virus Update - 12/21/18

REGULATORY UPDATE: FDA Releases Recommendations for Labeling of Red Blood Cells with Historical Antigen Typing Results – 12/21/18

REGULATORY UPDATE: Cesium Irradiator Replacement Project Supported by New Law – 12/21/18

REGULATORY UPDATE: AABB Requests Member Comments on Bacterial Risk Control – 12/14/18

REGULATORY UPDATE: 'Ask the FDA and CLIA/CMS' 2018 Annual Meeting Session Slides Now Available – 12/14/18

REGULATORY UPDATE: FDA Releases New Bacterial Risk Control Draft Guidance, Approves Additional 510(k) Clearance for Culture of Platelets – 12/07/18

AABB Updates Zika Virus Biovigilance Network to Incorporate FDA’s July 2018 Guidance – 12/07/18

REGULATORY UPDATE: FDA to Modernize 510(k) Clearance – 11/30/18

FDA Workshop Highlights Pathogen-Reduction Technology – 11/30/18

Ebola Virus Update - 11/16/18

REGULATORY UPDATE: FDA Issues Draft Dried Plasma Guidance – 11/09/18

REGULATORY UPDATE: AABB Continues to Monitor CDC Reports on Ebola Risk – 10/26/18

FDA Approves New DNA-based Blood Compatibility Test – 10/12/18

REGULATORY UPDATE: CBER Updates Secure Email Policy – 10/05/18

REGULATORY UPDATE: AABB, ABC and ARC Submit Comments on FDA’s Babesiosis Draft Guidance – 10/05/18

REGULATORY UPDATE: FDA Issues Two Draft Guidances – 09/28/18

REGULATORY UPDATE: FDA Updates eBER System – 09/28/18

REGULATORY UPDATE: FDA Issues Updated 2018 Guidance Agenda – 09/21/18

OBRR to Host Public Workshop on Pathogen Reduction – 09/14/18

AABB Releases Circular of Information User Guide as Exclusive Member Offering – 09/14/18

Nicole Verdun Named Director, Office of Blood Research and Review – 08/31/18

Reminder: ZIKV Testing Tool Kit Available – 08/31/18

REGULATORY UPDATE: Haemonetics Issues Urgent Recall of Leukotrap RC System – 08/31/18

Reminder: AABB Accepting Questions for "Ask the FDA" Session at the 2018 Annual Meeting – 08/17/18

AABB Accepting Questions for "Ask the FDA" Session at the 2018 Annual Meeting – 08/03/18

REGULATORY UPDATE: FDA Issues Draft Babesia Guidance – 07/27/18

REGULATORY UPDATE: AABB Posts Summary of Recent BPAC Meeting – 07/27/18

2018 CBER Science Symposium Videos Available – 07/20/18

FDA Releases 2017 Biological Product Deviation Report Summary – 07/20/18

BPAC Weighs in on Multiple Strategies for Minimizing Bacterial Contamination in Platelets – 07/20/18

REGULATORY UPDATE: FDA Grants Emergency Use Authorization for Freeze-Dried Plasma for U.S. Military Personnel – 07/13/18

REGULATORY UPDATE: AABB Posts Analysis of FDA Zika Virus Guidance – 07/13/18

REGULATORY UPDATE: Synthetic Cannabis and Anticoagulants – 07/13/18

AABB Accepting Questions for "Ask the FDA & CMS/CLIA" Session at the 2018 Annual Meeting – 07/13/18

News Flash FDA Releases Revised Final Guidance on Zika Virus Testing – 07/06/18

REGULATORY UPDATE: FDA Issues Updated 2018 Guidance Agenda – 06/29/18

REGULATORY UPDATE: FDA Releases Draft Agenda and Materials for July 18-19 BPAC – 06/29/18

AABB Staff Members Attend 2018 CBER Science Symposium – 06/29/18

REGULATORY UPDATE: Electronic Version of the October 2017 Circular of Information – 06/22/18

REGULATORY UPDATE: AABB, ABC and ARC Submit Comments Supporting ZIKV NAT – 06/15/18

REGULATORY UPDATE: FDA Issues New BECS Final Rule – 05/25/18

REGULATORY UPDATE: FDA Announces BPAC Meetings and CBER Research Symposium – 05/25/18

REGULATORY UPDATE: FDA Approves Procleix Ultrio Elite Assay – 05/18/18

REGULATORY UPDATE: Ebola Outbreak Expands in Democratic Republic of the Congo – 05/18/18

REGULATORY UPDATE: FDA Withdraws Direct Final Rule – 05/11/18

REGULATORY UPDATE: CDC Updates Malaria Risk in Costa Rica – 05/11/18

Democratic Republic of the Congo Confirms New Ebola Outbreak – 05/11/18

REGULATORY UPDATE: CDC Confirms Resolution of Malaria Outbreaks in Costa Rica and Cape Verde – 04/20/18

REGULATORY UPDATE: AABB Posts Summary of FDA Liaison Committee Meeting - 04/13/18

Warnings Regarding Synthetic Marijuana Use by Plasma and Blood Donors - 04/13/18

REGULATORY UPDATE: CDC Updates Malaria Risk in South Africa - 03/30/18

REGULATORY UPDATE: Electronic Circular of Information - 03/16/18

REGULATORY UPDATE: FDA Approves First Tests to Screen Blood for Babesia - 03/09/18

REGULATORY UPDATE: FDA Announces Joint Advisory Committee Meeting - 03/02/18

REGULATORY UPDATE: FDA Approves Culture Bottle Options as Secondary "Safety Measure" Test - 03/02/18

REGULATORY UPDATE: FDA Updates Inspection Regulations – 02/02/18

REGULATORY UPDATE: CDC Updates Malaria Risk for Bahia State, Brazil – 02/02/18

FDA and DoD Launch Program to Expedite Availability of Medical Products for Military Use – 01/26/18

FDA Releases 2018 Strategic Policy Roadmap That Includes Blood and Cellular Therapies - 01/26/18

FDA Releases 2018 CBER Guidance Agenda - 01/26/18

CTMC Provides Recommendations to Address Nationwide Saline Shortage – 01/12/18

FDA Releases New and Updated Guidance Documents – 01/05/18