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New CDRH Decision Methods Will Be Put To The Test, Starting With Stents

This article was originally published in The Gray Sheet

Executive Summary

Defining a "new science" for post-market surveillance is a top priority for the FDA device center's post-market group, according to the program's new leader

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People In Brief

Device matrix leader: Jonathan Sackner-Bernstein assumes the role of associate director for post-market operations Sept. 2, tasked with overseeing CDRH's recently launched matrix organization, FDA announces Aug. 29. Sackner-Bernstein is the program's first permanent director, after acting heads Diane Mitchell and Don St. Pierre helped to set up the program (1"The Gray Sheet" July 21, 2008, p. 7). Prior to joining FDA, Sackner-Bernstein was chief medical officer at New York City-based contract research organization Clinilabs. Previously, he served on the faculty at Columbia University and was associate chief of cardiology at St. Luke's-Roosevelt Hospital. In addition, Sackner-Bernstein has sat on the cardiovascular and renal drugs advisory panel for FDA's drug center and the device center's dispute resolution panel

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