Number: RL34571
Title: Medical Device User Fees and User Fee Acts
Authors: Erin D. Williams, Domestic Social Policy Division 
Abstract: This report provides an overview of FDA and the medical device review process. It then presents the legislative history of user fees. Next, it explains the basics of FDA's medical device user fee system, noting the way in which various provisions have evolved. Finally, it provides an overview of non-user fee issues addressed in the device user fee acts.
Pages: 31
Date: July 14, 2008