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The FDA Medical Device User Fee Program


This report describes current law regarding medical device user fees, the impact of MDUFA on FDA review time of various medical device applications and the agency's medical device program budget, the MDUFA III proposal (legislative language and performance goals agreement), and issues that Congress is likely to take up as it works on the reauthorization of the medical device user fee program. Appendix E provides a list of acronyms used in this report. Bills: H.R. 5651, S. 2516


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# File Name Document Date Order ID: Number of Pages Price
1 R42508.pdf May 11, 2012 R42508 32 $29.95 Add to Cart

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