1998N-0046 Comprehensive List of Current Guidance Documents at FDA
FDA Comment Number : EC5
Submitter : Mr. Michael Campbell Date & Time: 04/13/2005 06:04:33
Organization : Olympus America Inc Diagnostic Systems Group
Category : Device Industry
Issue Areas/Comments
GENERAL
GENERAL
Guidance Document Docket # 91N-0467; DRAFT Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human Globulin, original version issued 1992, no revisions, is still in use by CBER, DBA. This document is not available other than upon direct request to CBER. It is not in the annual listing of guidances, all contact information on the front of the document is outdated, and it is no longer open for comments. CBER should not longer be expecting manufacturers to follow this document. Either re-issue the document according to good guidance practices or abandon use of it in all divisions of FDA.