HIMA device submissions workshop
This article was originally published in The Gray Sheet
Executive Summary
July 27-28 meeting in Washington, D.C. will include presentations by Office of Device Evaluation Director Susan Alpert on FDA's implementation of "least burdensome" requirements and by the device center's Jim Norman on the recent dispute resolution guidance. An opening speaker, scheduled to discuss Commissioner Jane Henney's priorities, international harmonization and user fees, has yet to be announced