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Washington Roundup, March 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposed comprehensive postmarket surveillance strategy, as well as updates on proposed 510(k) reforms and device user fees.

The device center within the US Food and Drug Administration (FDA) plans to propose a new national comprehensive postmarket surveillance strategy this spring. Jeffery Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), says the goal will be to establish an infrastructure that both the FDA and industry can leverage – not only to make post-approval data collection more effective and less burdensome but also to contribute to a faster, less-costly premarket process.

The national strategy is one of CDRH’s 2012 priorities. The center will issue its proposed postmarket strategy by April 30th, which will be followed by a public meeting with stakeholders...

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