AdvaMed Device Submissions Workshop In Brief
This article was originally published in The Gray Sheet
Executive Summary
MR compatibility: CDRH's science office plans development of "guidance and standards that will help manufacturers figure out MRI compatibility with devices," CDRH Deputy Director Linda Kahan tells participants at AdvaMed's 14th Annual Device Submissions Workshop June 3-4 in Arlington, Va. MR compatibility "is something that we find has held up applications for products," and the initiative is meant to speed reviews. The Office of Science & Engineering Laboratories (formerly the Office of Science & Technology) was reorganized this year ("1The Gray Sheet" March 15, 2004, p. 8)...