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Regulatory Updates

​This section serves as a quick reference for regulatory updates announced in AABB Weekly Report. In the coming weeks, updates from 2017-18 will be added to this page.

If you have questions, please contact the Regulatory Affairs Staff at

REGULATORY UPDATE: FDA Releases New Bacterial Risk Control Draft Guidance, Approves Additional 510(k) Clearance for Culture of Platelets – 12.07.18

REGULATORY UPDATE: FDA to Modernize 510(k) Clearance – 11.30.18

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

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REGULATORY UPDATE: AABB, ABC and ARC Submit Comments on FDA’s Babesiosis Draft Guidance – 10.05.18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

REGULATORY UPDATE: Haemonetics Issues Urgent Recall of Leukotrap RC System – 08.31.18

REGULATORY UPDATE: 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

REGULATORY UPDATE: 2018 CBER Science Symposium Videos Available – 07.20.18

REGULATORY UPDATE: FDA Releases 2017 Biological Product Deviation Report Summary – 07.20.18

REGULATORY UPDATE: 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

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 – 05.31.18

REGULATORY UPDATE: FDA Announces BPAC Meetings and CBER Research Symposium – 05-31-18

REGULATORY UPDATE: Ebola Outbreak Expands in Democratic Republic of the Congo – 05-15-18

REGULATORY UPDATE: FDA Approves Procleix Ultrio Elite Assay – 05-03-18

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 - 04-12-18

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 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