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Standards May-June 09

This article was originally published in RAJ Devices

Executive Summary


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The US FDA’s Medical Device Postmarket Transformation Initiative

US manufacturers of medical devices can expect to see increased scrutiny of their postmarketing reports as the US Food and Drug Administration’s Center for Devices and Radiological Health takes action to strengthen its Medical Device Postmarket Transformation Initiative. The initiative, launched in 20061, was designed to increase the ability of CDRH to identify, analyse and act on postmarket information, thereby improving the safety and effectiveness of medical devices and radiation-emitting products. It is focused on execution in four areas: creating a culture of collaboration within CDRH, developing world-class data systems, enhancing risk:benefit communication efforts and collaborating on enforcement strategies and outcomes.




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