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Compliance In Focus
Posted by John Lehmann on Thu, Jan 19, 2012

FDA Misses MDUFMA Deadline

MassDevice reports that the FDA missed its second deadline to submit a proposal to Congress for the Medical Device User Fee & Modernization Act (MDUFMA), which is set to be renewed this year. The device industry and the federal watchdog agency have been in discussion over the fees mandated by the Medical Device User Fee & Modernization Act.

The FDA would like to raise between $730-$850 million in additional revenue, a number which Med-tech balked at. They are proposing to pay $447 million, which the industry believes will cover about 26% of the agency’s medical device review budget for fiscal 2017, according to minutes for the December 6th meeting.

FDA and the industry remain far apart on the appropriate level of resources, with both sides expressing concern on how long it might take to reach agreement. With the Health sub-committee of the House's Energy & Commerce Committee slated to hold a hearing February 15th over the fees, it's not clear whether the parties can agree on a proposal by then.

Do you think both sides can hammer out an agreement prior to the February 15th meeting? Let us know what you think.

Topics: Medical Devices, john lehmann, FDA


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