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MDUFMA II Should Address Pre-IDE Process, Cycle Goals – Stakeholders

This article was originally published in The Gray Sheet

Executive Summary

FDA should work to improve the process by which companies and the agency negotiate clinical trial designs, several participants argued at the third annual MDUFMA stakeholder meeting Nov. 17

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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...

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...

CDRH “Innovation Initiative” Highlights Efforts To Speed Premarket Process

FDA seeks to underscore its commitment to help innovative new medical devices get to market more quickly with a report unveiled May 22

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