Issue Date: 03/01/2011
Issued By: Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
OMB Control No. 0910-0594
Expiration Date: 8/31/2024
We, FDA, are issuing this guidance document in conjunction with a Federal Register final rule reclassifying from class III to class II the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components. This guidance document serves as the special control to support the reclassification.