Under the proposed Medical Device User Fee Reauthorization, or MDUFMA III, the FDA wants user fees make up about 40 percent of its budget for reviewing medical devices. The agency first won the authority to collect user fees in 2002 under MDUFMA I. The current MDUFMA II will expire in 2012.
Under MDUFMA III, the agency wants a roughly 17 percent increase in user fees and to add 254 medical device employees to its current staff of 1,230.
Read official minutes of the FDA’s MDUFA III reauthorization meeting.
Related Articles on Devicemakers’ Concerns About FDA Oversight:
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FDA Acknowledges Concerns Over Device Approval Time
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