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# FDA Integrated Proposal for MDUFA 4 Discussed
- URL: https://www.fdaweb.com/fda-integrated-proposal-for-mdufa-4-discussed/
- Published: 2016-02-25T12:00:00.000Z
- Updated: 2026-09-15T02:38:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134887

> At a 1/27 MDUFA 4 reauthorization meeting, FDA presented an integrated proposal combining elements of industry and agency proposals on several topics. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM487811.pdf?ref=fdaweb.com) indicate that the agency presented additional details on certain aspects of the proposal and discussed each topic’s importance. Industry agreed to consider the proposal and to develop a counter-proposal for the next meeting. Industry also reaffirmed its interest in quantifying efficiencies FDA would realize from some of the proposals and enhancements.  
>  
> “FDA presented details and cost estimates for an integrated proposal that addresses issues important to industry, FDA, and in some instances both,” the minutes say. “FDA reiterated the opportunities for MDUFA 4, including ensuring a consistent, predictable, and efficient review experience. FDA’s proposal package bundled the proposals into several categories, including infrastructure, process improvement, innovation, and performance.”  
>  
> The agency estimated that the additional resources to implement its integrated proposals over the five-year authorization period of MDUFA 4 would total $500 million, in addition to the base amount of user fees needed to maintain the level of staffing and other activities supported by MDUFA 3 fees. The estimates do not include inflationary adjustments, the agency said.  
>  
> Minutes from the 1/20 [meeting](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM487810.pdf?ref=fdaweb.com), show that the two sides discussed the details of FDA’s cost estimate of previous industry proposals, as understood by the agency. FDA staff described the assumptions made to estimate the proposal costs. Rather than form separate working groups, the two sides held several working discussions of the proposal details during the meeting.