FDA's device center chief on 510(k) process, initiatives at the agency

05/15/2010 | Star Tribune (Minneapolis-St. Paul, Minn.)

Possible changes to the 510(k) clearance process and strategic priorities of the FDA's Center for Devices and Radiological Health are among the issues that will be discussed at a town hall-style meeting to be held Tuesday in Minneapolis, said Dr. Jeffrey Shuren, head of the agency's device center. In an interview with the Star Tribune, Minneapolis-St. Paul, Minn., Shuren also cited other programs the agency is working on, such as tougher guidelines on the design of clinical studies and enhanced oversight of imported medical products.

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Star Tribune (Minneapolis-St. Paul, Minn.)

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