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# FDA, Industry Have MDUFA 6 Agreement in Principle
- URL: https://www.fdaweb.com/fda-industry-have-mdufa-6-agreement-in-principle/
- Published: 2026-07-22T12:00:00.000Z
- Updated: 2026-09-14T13:43:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161498

FDA and medical device industry representatives have reached an agreement in principle on MDUFA 6 and have turned to writing the draft commitment letter to operationalize the agreement. Attorney **Jake Leys** (Gardner) writes in an online [post](https://www.jdsupra.com/legalnews/mdufa-vi-is-taking-shape-what-device-2529932/?ref=fdaweb.com) that the agreement will cover the 2028-2032 fiscal years ([see performance goals](https://www.fdaweb.com/mdufa-performance-goals-procedures-for-2028-2032/)). FDA says it will hold an 8/5 public meeting to discuss proposed MDUFA reauthorization recommendations.

Ley says minutes from the reauthorization negotiating sessions involving agency and industry representatives show four threads that mattered most to medical device companies: agency staffing transparency, fee mechanics, *de novo* and pre-submissions, and tying real-world evidence funding to premarket use and the National Evaluation System for health Technology.

He lists these key takeaways for manufacturers:

- program funding is expected to be flat with fee shifts likely and lower submission and domestic registration fees in FY 2028;
- staffing transparency should be treated as a planning tool;
- de novo packages should be strengthened now;
- plan real-world evidence around premarket use; and
- watch AI-device review capacity.

“MDUFA 6 is quickly moving from negotiation into drafting,” Leys concludes. “The companies that will benefit most are those that start aligning submission strategy with where FDA is allocating its limited resources.”