Upcoming Meetings: In Vitro Diagnostics Roundtable
This article was originally published in The Gray Sheet
Executive Summary
In Vitro Diagnostics Roundtable: FDA/industry group collaborating on IVD issues schedules Nov. 18 workshop to discuss preparation of 510(k) submissions for diagnostic devices. The meeting will be held at FDA's Baltimore district office; for registration information, contact Becton Dickinson's Zenia Ambrose at 410/316-4260. The IVD Roundtable consists of staffers from the premarket review and compliance offices in FDA's device and biologics centers as well as industry reps. The group has met quarterly since its formation in late 1995...