FDA 510(k) process report is upcoming, official says

06/23/2010 | MassDevice.com (Boston)

The FDA will release in a few weeks the results of its internal assessment of the 510(k) clearance program, said Dr. Jeffrey Shuren, head of the agency's device center. During a town hall meeting in Woburn, Mass., Shuren said the agency will not terminate the program and that it would ask for public comments on its findings before introducing changes to the process.

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MassDevice.com (Boston)

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