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# Industry Cuts FDA Ideas Out of MDUFA 4 Proposal
- URL: https://www.fdaweb.com/industry-cuts-fda-ideas-out-of-mdufa-4-proposal/
- Published: 2016-03-15T12:00:00.000Z
- Updated: 2026-09-15T02:44:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135083

> At a 2/18 FDA/Industry MDUFA 4 reauthorization meeting, AdvaMed, MDMA (the Medical Device Manufacturers Association, and MITA (the Medical Imaging and Technology Alliance) presented an updated proposal package including continuation of MDUFA 3 base resources to maintain the MDUFA 3 FTE levels and maintain FDA’s current performance, and proposals to invest in IT upgrades, continue the independent assessment, support patient engagement, and develop a quality management system. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM490308.pdf?ref=fdaweb.com) indicate that FDA staff asked clarifying questions about that proposal and also about industry’s concerns with some elements of the agency’s 1/27 proposal.  
>  
> The industry proposal included a two-tiered listing of topics for continued consideration and discussion and request to exclude consideration of review summaries for 510(k) sponsors and 513(g) performance goals.  
>  
> FDA raised concern that many elements in its 1/27 package were not included in the industry proposal and some that of the areas were important to the agency.