Regulatory for Blood and Blood Components

Blood, a living tissue circulating throughout the human body, is made up of red blood cells, white blood cells, platelets and plasma. Although often collected as whole blood and separated into major components prior to transfusion, automated apheresis collections have become common practice. Apheresis devices are continuous systems that remove blood from a donor, separate the blood into the desired components and return the remaining blood back to the donor.

In the U.S., the collection, testing, preparation, storage and transport of blood and blood components must comply with FDA regulations and guidance documents. On behalf of the transfusion medicine community and as part of ongoing collaborative efforts, AABB works directly with FDA, participating in formal rulemaking processes and government advisory committee meetings to help ensure the safe and effective collection and transfusion of blood products, as well as a safe and adequate blood supply.