The Deal That Sets Device Review Speed Through 2032 Just Got Made

On August 5, FDA held a public meeting to walk through its proposed recommendations for reauthorizing the Medical Device User Fee Amendments — MDUFA VI — the negotiated agreement that will determine how FDA's device review program is funded and how fast it moves for fiscal years 2028 through 2032. That meeting matters because of what preceded it: FDA and industry, represented by AdvaMed and the Medical Device Manufacturers Association, had already reached an agreement in principle on a genuinely compressed timeline, described at April's MedCon conference as a "record" pace for this kind of negotiation. The technical work is functionally done. What's left is the part that turns a negotiated agreement into binding law — publication, public comment, congressional briefings, and a transmittal deadline of January 15, 2027.

If that sounds like process for its own sake, it isn't. MDUFA is the mechanism that funds the majority of CDRH's device review staff and sets the performance targets — review timelines, response deadlines, staffing commitments — that FDA is contractually obligated to hit in exchange for the fees device companies pay on every premarket submission. The current program, MDUFA V, expires September 30, 2027. Whatever gets negotiated now determines review speed, review predictability, and review cost for essentially every device company operating in the U.S. market for the next five-year cycle, and the shape of that agreement is now largely set.

What's actually in the agreement, based on what's public so far

FDA's Barbara Marsden, Acting Director of the Office of Regulatory Programs, has said publicly that user-fee funding will stay "largely the same" between MDUFA V and MDUFA VI — not a dramatic increase, not a cut, but continuity. That's worth noting on its own, because it signals FDA isn't using this negotiation to argue for a significantly larger device-review budget, even as device submission volume and complexity, particularly around AI-enabled devices, has grown. The agency has also said it met or exceeded its MDUFA V performance goals — often at or above 90% — and that MDUFA VI's goals will look similar, which suggests FDA is confident enough in its current review-speed performance not to renegotiate the targets downward, but also isn't proposing to make them dramatically more ambitious either.

The more interesting detail is what the fee funding is earmarked to do beyond straight staffing. Both sides have agreed to direct a portion of the next funding cycle toward IT infrastructure upgrades — specifically, further automating submission processing and improving portal functionality, with FDA noting the maintenance costs from this investment will extend beyond 2032, past the end of the MDUFA VI cycle itself. That's a meaningfully long-term commitment for a five-year funding agreement to make, and it signals FDA sees its current submission-handling infrastructure as a genuine bottleneck worth a multi-cycle investment to fix, not just a minor inconvenience. Also on the table: updates to the de novo and pre-submission programs, developed through both formal negotiation sessions and offline technical discussion between the two sides, and continued build-out of the Total Product Life Cycle Advisory Program (TAP), which FDA has been expanding as a more consultative, ongoing-relationship alternative to the traditional pre-submission and review process.

Staffing came up as its own distinct thread in the negotiations, separate from the funding-level discussion. Public meeting minutes point to CDRH staffing levels becoming a specific focus, with discussion of additional transparency commitments and future hiring targets — a signal that even with funding staying flat in real terms, both sides recognize that review capacity, not just review budget, has been a live concern industry wanted addressed directly in the agreement language rather than left to FDA's internal discretion.

Why the stakeholder consultation process matters as much as the industry negotiation

MDUFA reauthorization isn't only a conversation between FDA and device manufacturers. The statute requires FDA to hold periodic consultation meetings with a broader stakeholder group — patient and consumer advocacy organizations, healthcare professionals, and academic and scientific experts — running in parallel with the industry negotiation track. Those meetings, held roughly monthly since the process kicked off, have surfaced a different set of priorities than the industry-focused sessions: post-market surveillance resourcing came up repeatedly, along with an explicit tension between authorization speed and safety that stakeholder groups pushed FDA to address directly rather than treat as a solved problem. FDA's February 2026 stakeholder session included a walkthrough of the CDRH 2025 Annual Report covering early alert communications, real-world evidence use, international affairs, and the QMSR transition — suggesting the agency is treating this consultation track as an opportunity to report progress on commitments made in the current cycle, not just gather input for the next one.

That dual-track structure matters for how confidently industry should read "agreement in principle" as a done deal. The industry negotiation determines the fee structure and the specific performance and program commitments FDA is willing to make. But the public comment period, and the stakeholder input already gathered, still shape what actually survives into the final commitment letter and, ultimately, what Congress is willing to pass largely intact versus amend. A "record timeline" negotiation between FDA and industry doesn't eliminate the possibility that public comment or congressional review introduces changes — particularly around any provision stakeholder groups flagged concerns about during the consultation track, like post-market resourcing.

What TAP expansion actually signals

The Total Product Life Cycle Advisory Program deserves more attention than a passing mention, because its continued build-out inside MDUFA VI says something about how FDA wants its relationship with device sponsors to evolve. TAP was designed as a more consultative, ongoing engagement model — sponsors get earlier and more frequent interaction with FDA review staff across a product's development lifecycle, rather than the more transactional pattern of formal pre-submission meetings followed by a single review cycle. Continued investment in TAP as part of the next funding agreement suggests FDA sees this relationship-based model as a genuine efficiency lever, not just a pilot program running alongside the traditional process. For sponsors of novel or higher-risk devices in particular, where the back-and-forth of formal review can add real delay when early misunderstandings compound into late-stage review questions, that's a meaningful signal about where to invest regulatory strategy time going forward — a sponsor that engages early and consistently through a TAP-style relationship is likely to be better positioned under MDUFA VI than one that treats FDA interaction as a series of discrete, formal touchpoints.

What history suggests about the gap between "agreement in principle" and final law

It's worth tempering optimism about a "record timeline" negotiation with what past MDUFA cycles have shown about the distance between an industry agreement and the law that actually passes. Every prior MDUFA reauthorization — MDUFA II through V — followed a broadly similar path: FDA and industry reach a negotiated agreement, publish it, take public comment, and then Congress folds it into a larger legislative package that, historically, has become a vehicle for additional FDA-related policy riders unrelated to the core user-fee mechanics themselves. That pattern is part of why "must-pass" legislation status cuts both ways for industry: it guarantees the core funding mechanism gets renewed on a predictable schedule, but it also means the bill becomes an attractive vehicle for other legislative priorities that have nothing to do with device review timelines, which can introduce delay or last-minute changes that a purely technical FDA-industry negotiation can't fully insulate against. Device companies that assume MDUFA VI's substance is fully locked in based on the August negotiation alone are extrapolating past what "record timeline" actually guarantees — a fast technical negotiation reduces uncertainty about FDA and industry's shared intent, but Congress remains a genuinely separate variable.

What this means for planning now, not in 2028

Device companies don't need to wait for final passage to start factoring MDUFA VI into planning, because the broad shape of the next five years is now reasonably visible even before the ink is formally dry. Submission volume and review capacity planning should assume performance goals similar to MDUFA V rather than either a dramatic speedup or slowdown — the "largely the same" funding signal, paired with similar performance targets, suggests FDA is planning for continuity rather than a structural shift in review speed. Companies relying heavily on the pre-submission process, or considering deeper engagement with TAP, should watch for the specific commitment letter language on those programs closely, since that's where the negotiated changes to how FDA engages pre-submission are most likely to land in practical, usable detail. And any company whose regulatory strategy assumes a certain baseline of CDRH staffing and responsiveness should treat the staffing-transparency commitments as worth tracking specifically — not because they're likely to solve capacity problems overnight, but because they're the mechanism by which industry will be able to hold FDA accountable to specific hiring and capacity targets over the next cycle, rather than relying on anecdotal reports of review delays.

The version of this story that gets attention is usually the funding number — how much MDUFA VI raises or doesn't. The more consequential story this cycle is the IT infrastructure commitment extending past 2032, the TAP expansion, and the staffing transparency language, because those are the pieces that actually determine whether the next five years of device review feel meaningfully different to a company moving a product through the pipeline, regardless of what the headline fee figure ends up being.

Sources: RAPS, MedCon: FDA reaches agreement in principle with industry for MDUFA VI negotiations in "record timeline"; RAPS, MDUFA VI: FDA, industry make headway in reauthorization negotiations; Gardner Law, MDUFA VI Is Taking Shape; Holland & Knight, FDA User Fee Act Reauthorization; FDA Stakeholder Consultation Meeting minutes, January and February 2026; Federal Register, Medical Device User Fee Amendments Public Meeting Notice, July 2026.