IN THIS SECTION Resources Analysis QUICK LINKS Resource Guide on Labeling, Storage and Comparability of Plasma Components Technical Amendment to Final Rule on the Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma   Direct Final Rule on the Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma Proposed Rule on the Requirements for Human Blood or Blood Components Intended for Transfusion or Further Manufacturing Use Contact AABB Regulatory Affairs Department

Overview
Blood, a living tissue circulating throughout the human body, is comprised of red blood cells, white blood cells, platelets and plasma. Although often collected as whole blood, donations typically are separated into these major components prior to transfusion. Facilities that collect and transfuse blood for specific treatment needs must follow individualized protocols for each component to help ensure that it remains viable for patient care.

In the U.S., the collection, testing, preparation, storage and transport of blood and blood components is governed by Food and Drug Administration regulations and guidance documents. On behalf of the transfusion medicine community and as part of ongoing collaborative efforts, AABB works directly with FDA and through government advisory committees to ensure the safe and effective collection and transfusion of blood products. In addition, AABB works with other federal agencies, including the Center for Medicare and Medicaid Services, to achieve adequate reimbursement for blood and blood products.

Recent Actions:

2/8/08
The FDA issues a technical amendment responding to comments received on the direct final rule that revised the requirements for blood, blood components and source plasma.

1/11/08
The FDA announces the extension of the comment period to Aug. 4 for a proposed rule on the requirements for human blood and blood components intended for transfusion or for further manufacture.