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A Leading Question: When Is Human Testing Needed For ICD Approval?

This article was originally published in The Gray Sheet

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Executive Summary

Debate is surfacing in the medical and regulatory community over when clinical data is needed to approve new implantable cardioverter defibrillator technology

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Dr. Maisel Goes To Washington: CDRH Advisor, Critic Joins Senior Staff

CDRH has hired a longtime FDA advisor and sometimes outspoken agency and industry critic to lead efforts to improve the way new science is incorporated into agency policies

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CDRH has hired a longtime FDA advisor and sometimes outspoken agency and industry critic to lead efforts to improve the way new science is incorporated into agency policies

Heart Rhythm Experts Release New Pacer/ICD Lead Management Guidelines

New recommendations from leading heart experts call on physicians, device manufacturers and FDA to do a better job monitoring and managing the safety of pacemaker and implantable defibrillator leads
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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