Jump to content
TMOSLEY

Neonatal Exchange-FDA Registration

Recommended Posts



Yes you do! In accordance with 21 CFR 607.21, you must register and list the blood products you manufacture ( when you reconstitute, you are manufacturing a new product = whole blood ( new ISBT #) for commercial distribution every year between October 1 and December 31 and you must update your blood product listing every June and December. I hope that helps.

Simret

 

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

  • Advertisement

×