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Medical Device User Fees and User Fee Acts (CRS Report for Congress)

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Release Date Revised April 26, 2010
Report Number RL34571
Report Type Report
Authors Erin D. Williams, Specialist in Public Health and Bioethics
Source Agency Congressional Research Service
Older Revisions
  • Premium   July 14, 2008 (36 pages, $24.95) add
Summary:

This report provides an overview of FDA and the medical device review process. It then presentsthe legislative history of user fees. Next, it explains the basics of FDA's medical device user feesystem, noting the way in which various provisions have evolved. Finally, it provides anoverview of non-user fee issues addressed in the device user fee acts. This report will be updatedas events warrant.