User dmpollock had a different answer to this question in 2009: Hopefully most transfusion services are aware that they have to register with FDA, and thus will be inspected by FDA if they "manufacture" products. "Manufacturing" includes drawing donors and making components (other than splitting components). Even if the facility does not draw donors, but they leukoreduce products in the lab, or irradiate, they must be registered. I recently found that they require registration for preparing reconstituted whole blood. I am curious what people think of this and how they are handling it. From this page: http://www.aabb.org/Content/Programs...cripts2008.htm Question 37: I have a question regarding exchange transfusion. Can we issue AB plasma & RBCs in two separate bags that have been sterile docked together, but separated by use of a clamp so that the RNs can open the clamp and transfuse the product? Do we need FDA registration to do this? Response: If you sterile-dock plasma and RBC units together and issue it as a final product, you are performing a manufacturing step that is not covered by the exemption from registration in 21 CFR 607.65(f). You must register as a hospital blood bank. If you combine all or part of a red cell unit and a plasma unit and issue it as a final product, this is also manufacturing not covered by the exemption from registration, so you must register as a hospital blood bank. If you issue separate red cell and plasma units, the administration of these products is a practice of medicine for which we would not require registration. We encourage you to take a quality approach. Decide what process will minimize the risk and maximize the benefit to your patients, then determine the requirement for you to register with FDA.