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User Fees In Administration's Budget Request Aimed At Third-Party Program

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health is hoping that the most recent user fee proposal set forth in the administration's FY 2001 budget request might breathe some life into the agency's moribund 510(k) third-party review program.

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FDA Offers $4,000 To Cover Cost Of Third-Party Review Expenses

FDA would provide the first $4,000 to help companies defray the cost of third-party 510(k) review for eligible devices, the agency explains in its FY 2001 budget justification document.

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