- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This memorandum addresses the temporary deferral of Source Plasma donors who have lost red blood cells due to technical difficulties during an automated plasmapheresis procedure.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610.