Minnesota experts raise their concerns about FDA approval process

05/19/2010 | Star Tribune (Minneapolis-St. Paul, Minn.)

Several speakers expressed concerns with the FDA's approval system for medical devices, such as long timelines and a lack of certainty in the process, during a town hall meeting in Minneapolis-St. Paul, Minn., on Tuesday. Meanwhile, Dr. Jeffrey Shuren, director of the FDA's device unit, assured the participants that the agency has no plans to terminate the 510(k) program, and said the agency plans to disclose possible changes to the program in a few weeks.

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

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