No significant changes imminent to 510(k) process

12/13/2009 | Star Tribune (Minneapolis-St. Paul, Minn.)

Dr. Jeffrey Shuren, acting director of the FDA's device center, refuted claims that the agency would make significant changes to the 510(k) process for medical devices and instead said that the agency is carefully working to improve the process, this Star Tribune editorial says. "The challenge for the FDA is to strengthen its process without stifling new products and putting an undue regulatory burden on device companies, which are struggling to find venture capital in today's economy and potentially face a hefty new tax to fund health reform," the editorial says.

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

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