FDA Mulling Higher User Fees For Bundled Submissions

Article preview from "The Gray Sheet"- May 16, 2011

FDA is considering increasing user fees or lengthening the review performance goals for pre-market submissions that bundle multiple devices into a single application.

FDA Mulling Higher User Fees For Bundled Submissions

Article preview from "The Gray Sheet"- May 16, 2011

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.

Bundling is appropriate for devices that present scientific and regulatory issues that can most efficiently be addressed during one review, such as submissions where the supporting data are similar, one review division or group will be involved, and the devices or indications for use are similar, FDA says.

Continued...

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