CDRH Outlines New System For Tracking IDE-Related Submissions-thegraysheet: A new system for processing investigational device exemption submissions will allow CDRH to track multiple studies of the same device, including feasibility and pivotal trials, under a single IDE submission number. The changes to the IDE submission structure will take effect Aug. 18, FDA announced July 29. Each subsequent submission to an original IDE submission will be assigned to the appropriate study so FDA can track milestones in clinical trial development, IDE approval, study initiation and study completion, the agency said.
