FDA Registration

[Juray]

Can anyone clarify?  We are a hospital system with 6 sites/BBTS.  We do not collect any blood products but do split and thaw products.  Recently our blood supplier stated that if we "create" thawed plasma, which is an unlicensed product, we would need to register with the FDA.  There is also some question regarding registration if the product is transported outside the thawing facility.  Does anyone know for sure if FDA registration is required?  Thanks!

[Deny Morlino]

I seem to remember discussion regarding the thawing of frozen plasma as a necessary part of the process to allow transfusion of the product (can't very well transfuse a frozen unit after all).

 

I think that splitting of a unit is considered "manufacturing" and would require registration (we just dropped our splitting policy and no longer provide split units due to low request rate).

[LCoronado]

If you thaw FFP and transfuse or outdate it within 24 hours, you are not creating a new product.  If, however, after the 24 hours you rename the product from "FFP Thawed" to "Thawed Plasma" (5 day expiration), you have created a new product.  I know this requires a new ISBT label and may also require FDA registration. 

[tbostock]

Found this from a blood center:

Transfusion services must register with the FDA if they:

* routinely collect blood (manual or automated collections)

* routinely do component preparation (e.g., manufacture platelets, FFP, cryo)

* perform pre-storage leukocyte-reduction of blood components in the laboratory

* irradiate blood components

* wash red blood cells

* combine different components (e.g. red blood cells and plasma to make

reconstituted whole blood for neonatal transfusions)

* freeze or deglycerolize red blood cells

* collect and sell therapeutic exchange plasma

* use the Thermogenesis CryoSeal

* take possession of blood components for purposes of storage, re-labeling, or

further processing before distribution

* are not approved for Medicare/Medicaid reimbursement (e.g., VA hospitals or

foreign transfusion services)

* manufacture, prepare, or process (including donor testing) any blood products

subject to licensure

Transfusion services do NOT need to register with FDA if they:

* pool platelets immediately before transfusion

* pool cryo immediately before transfusion

* aliquot or divide components into smaller containers for ease of transfusion

* separate recovered plasma from whole blood to make red blood cells

* collect and discard blood from therapeutic phlebotomies and plasma exchanges

* temporarily store red blood cells from cell savers used in ORs

* issue bedside leukocyte-reduction filters with blood components

* perform compatibility testing and transfuse blood components

* thaw frozen plasma or cryo to prepare for transfusion

* use bed side leukoreduction filters to transfuse non leukoreduced red blood

cells.