REGULATORY UPDATE: AABB Introduces New FDA Blood Establishment Registration Toolkit

AABB’s Regulatory Affairs Committee developed a new FDA Registration Toolkit to support blood establishments in meeting federal regulatory requirements. This resource is designed to streamline compliance with 21 CFR Part 607 and Section 510 of the Federal Food, Drug and Cosmetic Act, focusing on registration and product listing requirements for establishments that manufacture, prepare or process blood and blood products.

FDA regulations at 21 CFR  607.21 require that blood establishments register within five days of beginning operations, renew registration annually between Oct. 1 and Dec. 31, and update product listings every June and December. These submissions must be made electronically through the electronic blood establishment registration (eBER) system, which replaced the paper-based form FDA-2830.

This toolkit provides:

• A step-by-step guide to the eBER submission process.
• Timelines for registration and product listing updates.
• Data entry requirements, including the need for a Data Universal Number System (DUNS) number.
• A flowchart to visualize the registration pathway.

By simplifying the process and reducing errors, the toolkit helps ensure timely and accurate submissions, enhancing regulatory compliance.

Members with questions may contact regulatory@aabb.org.