This guidance became obsolete with the release of the May 11, 2005 general software submission guidance jointly issued by CBER and CDRH.

FDA’s Center for Biologics Evaluation and Research “Reviewer guidance for a Premarket notification submission for blood establishment Computer Software ” issued in final form January 13, 1997. In addition to defining the requirements for a full Bood Bank Computer System 510(k) Submission CBER recognizes this document as a special control so that manufacturers can submit abbreviated 510(k)s if they claim compliance with this guidance document. The specific requirements for the abbreviated Submission are defined in slides from a CBER presentation. These slides are also available on this web site.

Keywords: BECS Blood Establishment