The Congressional Research Service (CRS) issued a report describing current medical device user fees law, the impact of Medical Device User Fees Act (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.
The report can be found here.
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