People In Brief

IDE director departs: FDA has yet to name a replacement for Elisa Harvey, who left her position Sept. 29 as investigational and humanitarian device exemption programs director within CDRH's Office of Device Evaluation. A primary challenge for whoever takes the job, in addition to directing IDE and HDE regulatory policy, will be overseeing the pre-IDE program, where sponsors have the chance to meet with FDA reviewers to get guidance on study design prior to initiating a pivotal trial. FDA staffers have said that pressure to fulfill MDUFMA application review timelines has limited the agency's ability to meet industry's growing interest in pre-IDEs (1"The Gray Sheet" Nov. 21, 2005, p. 9). Harvey spent more than 10 years at CDRH, previously as the review branch chief for peripheral vascular devices and as an Ob/Gyn device reviewer. She started Oct. 2 as a consultant at CardioMed Device Consultants, founded by former FDA interventional cardiology device reviewer Semih Oktay...