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FDA postmarket transformation plan

This article was originally published in The Gray Sheet

Executive Summary

A detailed report outlining implementation steps for CDRH's postmarket transformation initiative is due out in two weeks, said Susan Gardner, director, Office of Surveillance & Biometrics, during the Nov. 1 RAPS webcast. Announced in January, the four-point strategy aimed at enhancing the device center's surveillance techniques, focuses on agency collaboration, data sources and systems, risk communication, and compliance and enforcement (1"The Gray Sheet" Jan. 23, 2006, p. 5)...
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