Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VI
Industry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry offers improvements over the current program while addressing the agency’s resource constraints.
Philip Desjardins, a partner at Arnold & Porter, said the latest MDUFA deal was negotiated more quickly than previous ones. He argued that that was probably because both sides had gained significant experience from the previous negotiations to align on what optimal resources the agency needs to do its job. (RELATED: MDUFA VI: Draft commitment letter details enhancements, performance goals, Regulatory Focus 8 July 2026)
“I think there was greater alignment going into the negotiations, into the discussions, and there wasn't as much disagreement as to what resources were necessary, how those resources should be deployed,” Desjardins told Focus. “That's not to mean that industry threw out a proposal and FDA agreed to it or vice versa, but it was around refinement in terms of a shared goal, and I think we largely see that reflected in the commitment letter."
Follow-up pre-submission process
The most significant new update to the MDUFA program would be to create a focused follow-up pre-submission process by the end of 2027, allowing sponsors to receive responses faster than with a traditional pre-submission request.
While FDA will continue to operate its traditional pre-submission program, which allows sponsors to engage regulators early as they prepare to submit a premarket submission, the new pathway would require regulators to respond to companies even earlier, within 45 days of receipt. If focused follow-up pre-submission requests don't meet certain requirements, they will be converted to a traditional pre-submission request.
"I think it has the potential to be very successful, both for the agency in terms of focusing their attention on the right issues, the right questions, and quite honestly, the right products,” said Desjardins. “It also can be beneficial for industry.
“With the reduction in timelines, I believe there's a targeted focus to address some of the challenges that the existing pre-submission process had,” he added.
Desjardins said the biggest challenge with the current pre-submission program is that it has become a “catch-all” program for questions that the agency can’t respond to quickly enough. He said that the program isn’t appropriate for every type of question, and more targeted questions that may be answered more quickly get delayed because they are treated like any other pre-submission question.
“We're providing more structure and reducing burden both on the industry side and the FDA side to get some of the answers,” said Desjardins. “My hope is that this process will become more efficient and more effective for industry and the agency together."
The draft commitment letter also includes a new fee for pre-submission requests, which can later be credited to the company if the product is submitted for a premarket application. Desjardins said that while there were no fees explicitly associated with pre-submissions, they were ultimately paid through the user fee program. However, he said he hopes that applying an explicit fee to the program will prompt companies to reframe their use of it and be more targeted in their questions.
"It's to try to make industry hopefully a little bit more reflective on how much are they providing the appropriate level of information in their pre-sub request, and are they using it as targeted as it was designed to be used," said Desjardins. "Particularly for the larger manufacturers, I don't think it'll significantly reduce the volume of pre-sub interactions that are happening there ... it may result in some internal shifts on the industry side in terms of how they resource and fund R&D projects.
"But the bigger impact is going to be on those smaller manufacturers, where maybe dollars are a little bit harder to allocate internally," he added.
Kelliann Payne, a partner at Hogan Lovells Cadwalader, was also appreciative of the focused follow-up pre-submission proposal. She noted that companies often come to her that may require up to seven pre-submission requests, and the new proposal may help streamline that process.
"I think it'll encourage people to use that pre-submission process, right," said Payne. "Some people are pretty hesitant about it and just think it goes too long and has too many cycles right now.
"I think it'll make people look at the quality of their pre-submission a little closer and maybe be a little more strategic about when you file a pre-sub and kind of what goes into those pre-subs," she added.
Major deficiency letters
Desjardins was also optimistic about how the draft commitment letter addresses FDA's requirements when issuing major deficiency letters. He noted that the industry has long complained of a lack of detail in the letters, especially since a significant portion of the agency was fired or resigned over the past year and a half. In the commitment letter, the agency said it would ensure that, moving forward, they are based on a complete review of the submission and include all the deficiencies reviewers have found.
"When you look at the overall MDUFA V report outs that industry is seeing on a quarterly basis over the last year and a half, we have not seen a huge slip off or downfall in terms of CDRH hitting their MDUFA tracked commitments," said Desjardins. "But what I will tell you anecdotally is I've seen less and less detail in these major deficiency letters over the course of the last year and a half than I had for maybe the five years prior to that."
"I think it's more a reflection of the available resources the agency has to work on all projects that the center has to work on," he added. "What you're seeing as reflected as commitments in MDUFA VI is an acknowledgement of industry's expectations and needs for the level of detail, and trying to articulate it more in the commitment letter."
Payne echoed that there have been significant concerns about FDA’s resources, especially in light of the recent reduction-in-force effort. As a result, she notes that the proposed MDUFA program relies heavily on increased training and expanded internal resources, especially given the agency's loss of significant institutional knowledge.
"I think they're doing a fantastic job for what they have," said Payne. "I just think they're resource-constrained, and a lot of good people left."
"There's only so much juice you can squeeze out of an agency that's resource-constrained," she added.
Payne was also appreciative of the FDA's commitment to providing more complete responses in its major deficiency letters. She said that's the way it should be, and under the current system, companies often feel like they're standing on shifting sands, waiting for the agency to keep raising new issues with every response.
"A lot of times with these major deficiencies, we have to go get new data, we have to go run new testing, and to have that change is challenging and it's not fair," said Payne. "People invest millions and millions of dollars in these technologies, and then you don't always know what you're working with
"What I've seen lately is the clock runs out a lot, so we're forced to withdraw filings because you're getting things, and then you have to respond, and there's just not enough time left at the end," she added.
TAP
The total product lifecycle advisory program (TAP) pilot, which enables industry to seek early engagement with external parties, including patient organizations, medical societies, and payers, was a major sticking point during the MDUFA V negotiations.
While the medtech industry initially opposed the program, it eventually acquiesced to a pilot to evaluate its viability. Under the MDUFA VI proposal, both sides have agreed to elevate the pilot into a full-fledged program.
Desjardins noted that there’s still some skepticism from industry about the value of the TAP program, though that skepticism is not an outright rejection of its potential benefits.
"There's an acknowledgment that that's probably not the hill that industry needs or wants to die on,” said Desjardins. “If FDA thinks that this is a viable path to add that additional value to accelerate innovation, my perception at least, is that industry does not want to get in the way of something that might be valuable here.”
Payne noted there has been some success with TAP, which may explain why there was no pushback from industry this time around.
"People have had good experiences with TAP," said Payne. "It brings more than just FDA to the table.
"You can get the institutes and the people that make the guidelines to the table, so that when you get through the agency, you are now part of these guidelines, and there's reimbursement pathways and the like," she added.
Decision timeframes
In the draft commitment letter, FDA agreed to provide a decision on 510(k) submissions, on average, within 128 calendar days at the start of MDUFA VI and to work to reduce that to 112 calendar days by FY 2032. However, aside from that, the agency has maintained the same decision timeframes as in the previous iteration.
Desjardins said that with unlimited user fees, it may be possible to bring those timelines down even further, but that may not be pragmatic. He opined that it seems that industry and FDA have come to an agreement that any effort to reduce such timelines would ultimately not be worth the added user fee costs.
"I think we could absolutely bring those numbers down, but there becomes a point of how valuable is that extra three days or five days or even sort of 10 days, and if it's going to require a doubling of resources to shave off five days off of the review clock,” said Desjardins. “I think we have found the sweet spot at least in terms of where industry sort of perceives that value.
“Having worked in industry, having worked with R&D and marketing teams, an additional 15 days is not nearly as valuable as greater predictability,” he added.
