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FDA Mulling Higher User Fees For Bundled Device Submissions


5/17/2011 7:51:41 AM

FDA is considering increasing user fees or lengthening the review performance goals for pre-market submissions that bundle multiple devices into a single application. According to agency staffers, the current review paradigm for bundled submissions and certain diagnostic 510(k) submissions creates an uneven playing field. A bundled submission may include multiple devices, or multiple indications for use for one device, in a single pre-market submission.

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