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# FDA Reviews Proposal Status at MDUFA 4 Meeting
- URL: https://www.fdaweb.com/fda-reviews-proposal-status-at-mdufa-4-meeting/
- Published: 2016-02-03T12:00:00.000Z
- Updated: 2026-09-15T02:33:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134671

> At the 1/11 MDUFA 4 reauthorization patients and consumer stakeholder meeting, FDA reviewed the current status of a number of proposals and addressed clarifying questions from stakeholders. Meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM484620.pdf?utm%5Fsource=dlvr.it&utm%5Fmedium=twitter) indicate that the agency identified the places of commonality in proposals posed by it and industry such as with *de novos* and pre-submissions. It reported that the two sides agreed to address differences in approach through more detailed working group discussions to determine the best path forward to bring the sides together.  
>  
> Clarifying questions and concerns raised by industry discussed at the meeting involved the third-party review program for 510(k) submissions, *de novo* program process, and patient-reported outcomes, patient preference information, and national registries.