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CDRH matrix organization goes live

This article was originally published in The Silver Sheet

Executive Summary

Leaders of CDRH's new post-market safety matrix organization are officially on the job after six months of initial training and testing of the collaborative system. The matrix model brings together pre-market reviewers, adverse event analysts, scientific researchers and others to evaluate risks for different device types ("The Silver Sheet" February 2008). The matrix adds a new column to CDRH's organizational chart and involves nine product-based groups: cardiac electrophysiology; cardiac non-electrophysiology; infection control, dental, general hospital and infusion pumps; plastic surgery and breast implants; restorative, obstetric-gynecologic and general surgery; orthopedics; gastroenterology, urology and renal; neurology, anesthesia and respiratory; and ophthalmology and ENT (ear, nose and throat). In addition, four overarching networks cover crosscutting scientific and regulatory issues, diagnostics, and radiological products
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