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# Industry Unhappy with Latest FDA MDUFA 4 Proposal
- URL: https://www.fdaweb.com/industry-unhappy-with-latest-fda-mdufa-4-proposal/
- Published: 2016-04-27T12:00:00.000Z
- Updated: 2026-09-14T20:57:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135515

At the 3/4 MDUFA 4 reauthorization meeting, industry representatives expressed concern that there was a large gap between an FDA proposal made at the meeting and the proposal that industry presented at an earlier meeting. [Minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM495919.pdf?ref=fdaweb.com) from the 3/4 session indicate that the agency’s updated proposal package supports its objectives for sustaining and enhancing the program. As requested by industry, FDA said, it had prepared a proposal package that explored ways to reduce cost and optimize the package benefit/cost ratio.

The agency proposal would add $329 million to the MDUFA 3 baseline over five years and add 201 FTEs by the end of MDUFA 4\. It included components that reflect FDA’s highest priorities for sustaining and enhancing the program organized into two groupings.

Industry representatives reportedly expressed disappointment that the proposal sought an additional $329 million for enhancements that did not align with industry priorities, and without including any improved performance goals for *de novo* submissions or pre-submissions.

The minutes say that the agency explained that the proposal clarifies its own priorities and shows how costs could be reduced. It also says that the most recent time reporting data reveals trends that indicate a higher level of effort would be required to attain previously proposed performance levels due to increased intensity of interactions and effort involved in reviewing submissions, and especially submissions associated with the direct *de novo* program and the expedited access pathway.

“FDA and AdvaMed, MDMA, and MITA acknowledged that there remains a significant gap between the parties regarding what are considered high priority components and the scope of the negotiations going forward,” the minutes conclude, “and that the parties need to find a way to close this gap so that the scope of the ongoing MDUFA 4 discussions can be further clarified before working through the details that will determine the exact resource levels and features of an agreement.”