About This File
- Docket Number: FDA-2016-D-4308
- Issued by: Center for Biologics Evaluation and Research
We, FDA, are issuing this guidance document to provide you, establishments that collect blood and blood components for transfusion, with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). This guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. This guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12. This guidance does not apply to test results for ABO and Rh(D) antigens. For ABO and Rh(D) antigens, you must follow FDA requirements in 21 CFR 640.5(b) and (c), and 606.121(c)(9) and (13), as well as all other applicable requirements.
Recommended Comments
There are no comments to display.
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 accountSign in
Already have an account? Sign in here.
Sign In Now