FDLI/CDRH videoconference
This article was originally published in The Gray Sheet
Executive Summary
July 15 premarket update discussion with FDA topsiders will address such issues as in vitro diagnostics classification/reclassification, new IVD guidance documents, and changes in the 510(k) program - including abbreviated, special, and exempted 510(k)s. The conference will conclude by addressing several emerging premarket issues including modular premarket approval review, product development protocols and recognition of standards. FDA Office of Device Evaluation Director Susan Alpert and Division of Clinical Laboratory Devices Director Steve Gutman are among the agency personnel scheduled to speak. The conference will be held between 1:00 PM and 3:30 PM eastern standard time. For further information, call 800/956-6293