Minnesota group airs concerns over proposed 510(k) process changes

04/22/2010 | Star Tribune (Minneapolis-St. Paul, Minn.)

The Minnesota Medical Device Alliance said the proposed changes to the 510(k) process may require firms to conduct more clinical trials and delay product approvals. In a meeting with Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, the group called on the agency to retain the current regulatory framework while bolstering collaboration and communication with device makers.

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

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