Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components.

摘要

We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the document entitled Circular of Information for the Use of Human Blood and Blood Components (Circular) dated April 2013 (April 2013 Circular). The April 2013 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (S 606.122). The requirements under S 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the circular of information. This guidance supersedes the guidance of the same title issued October 2009 and updated in December 2009.