FDA Registration

[ffriesen]

We currently do not manufacture or modify products and are not licensed with the FDA. We are implementing a new blood bank computer system in January and plan to convert FFP to thawed plasma with a 5 day expiration date. I believe this means we must register with the FDA. Is this correct?

[David Saikin]

correct

[Townsend]

You may want to check with the FDA on this, or you may be able to find the answer in previous "Ask the FDA" sessions from AABB - I am fairly certain that this does not require FDA registration.

[David Saikin]

On ‎10‎/‎01‎/‎2018 at 10:11 AM, Townsend said:

You may want to check with the FDA on this, or you may be able to find the answer in previous "Ask the FDA" sessions from AABB - I am fairly certain that this does not require FDA registration.

Thawed plasma is a new product.  If you make it you should be registered.

[Patty]

Correct, needs FDA registration and I believe you will need to get something that will re-label the 5 day plasma as a new product using ISBT coding.

[Texas Lynn]

this is what I found from AABB "ask the FDA'

estion 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities.

• thaw plasma and split RBCs
• receive washed red cells from the blood supplier and then add plasma for an exchange transfusion
• divide red cell or platelet products for pediatric use
• re-label thawed fresh frozen plasma to thawed plasma

MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.

[pinktoptube]

3 hours ago, Texas Lynn said:

this is what I found from AABB "ask the FDA'

estion 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities.

• thaw plasma and split RBCs
• receive washed red cells from the blood supplier and then add plasma for an exchange transfusion
• divide red cell or platelet products for pediatric use
• re-label thawed fresh frozen plasma to thawed plasma

MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.

We only thaw plasma/cryo and rarely split RBCs and the FDA stated registration is not needed. When in doubt just ask them, they are always helpful. 

[Eagle Eye]

No. You do not require FDA registration for thawed plasma. Thawed plasma is not FDA licensed product. 

You do not need variance anymore  for converting FFP to Thawed plasma and give 5 days shelf life .

[ffriesen]

The answer from the FDA was as several of you suggested. We do not have to register. Thawed plasma is not a licensable product.