MDUFA VI: What Every MedTech Company Needs to Know Now

That's a new voice. Make co-host. Hey, it worked.

Yes. Base.

Okay. So, let's get this party started. Hello, and welcome everybody, to the Friday Unfocused call, with today, David Filmore, talking about MDUFA 6, what every MedTech company needs to know. Before I get started, just a few quick things. This session is being recorded. The recording goes to all registrants afterwards. David, I believe you're going to share your slides, is that correct?

Yes, I will. Let me know when.

Okay, so we'll share the slides, as well. Use the QA box if you want to ask David, questions directly. I'm also going to put a link in, to a post that I did. like, 45 minutes ago on LinkedIn. Asking you to post your comments or questions there, and trying to, create a simultaneous, live discussion on LinkedIn, as… as we go. So, I'll drop that link in into the chat in a second. Second thing is, as we're looking for speakers, especially private company speakers, not people selling

into manufacturers, people working inside them. If you have a problem that other people are still stuck on, that's what this Friday Focus In Focus session is about. If you want to recommend somebody, one of your clients, feel free to do so. You can, either drop me a DM or, message me directly. Third, and this is a new one, so… Recently, I've had a lot of people coming to me for referrals. Can you know somebody who can help with this, with, you know, CR, with this, that, or the other thing? And so, what I've decided to do, tentatively, is to, start a partner network within MLVX, is rather than everyone having to start their own partnership program, if you just join the partnership program, then you can be like, hey.

Let me look at the list. and see who's on the list, and, you know, pick… pick a partner, from there. I mean, you can still message me, I don't mind, but… and then, You know, because a lot of… Ways that, consultants Grow their business, and platform providers is when another consultant walks them in. Right. And so, a lot of people are… that are coming to me are like, hey, I… I need somebody that can do reimbursement coding, right? That's somebody who can do this. And I just… or packaging, or whatever, testing, who knows, you know, cybersecurity, and…

we know all those people, so I'm thinking about having a meeting. If you think this is a good idea, say good idea in the chat. If you think it's a crap idea, you can put the little poo emoji in there, or you can, just ignore it. It's up to you. Finally, the announcements next Friday, July 31st. Yes, there's 5 Fridays this month. Andre DiMino, President and CEO of ADCO Manufacturing, on designing electronic medical devices that actually reach production. So, this is contract manufacturing and design, and what happens when a design that works on the bench meets real production line. I think this is going to be a fascinating thing, because, it's very real world.

Then, Thursday, August 6th, Beyond the Protocol, a realistic resource and planning guide for human factors validation success, with Denise Forky and Leah Berkwist from Claramed, and Kira Favica from formerly from MedTronic, she's in med school now. And then Wednesday, the 19th, when enrollment stops, diagnosing a study that's already gone wrong, with Daniela Carrera, VP of Clinical Affairs from Donoa Life Science. I think that's gonna be a fascinating discussion. She's bringing actual cases of things that went way wrong, and And they stepped in to, fix them. So…

That is a good thing. So, now, today, MDUFA 6, what every MedTech Company Needs to Know. This is our guest, David Filmore. Full disclosure, David Filmore and I worked together at Elsevier Business Intelligence on the gray sheet many, many, many years ago. I don't even remember how many years ago, but probably pushing 20. And he is… the executive editor at Market Pathways. The MedTech Strategist publication covering global MedTech market. access across regulatory reimbursement and policy. He reads FDA device policy documents professionally, which means

he read the MDUFA VI draft agreement. The rest of us don't have… so the rest of us don't have to. Here's why it matters. You know. It's gonna cover fiscal years 28 through 32, and, and it… and it funds the things, so I'm gonna let him, do a much better job than me, talking about, what is it? It's like half of CDRH's budget. is generated through these fees. So, understanding these fees, who pays these fees, what these fees apply to, you know, this is… this is an important… topic, and I look forward to hearing what he has to say. I am

done talking, except to say that if you want to be promoted to panelist, and you have not been, raise your hand, and Francesca will do so. And… I'm gonna put a whole bunch of links in the chat while he gets started. Thanks. Thanks, David.

Well, thank you. Thank you, Shauna. I appreciate it, and really a pleasure to be on this call with this group of experts in this community. It's a cool thing you do every week, and I'm… you know, happy to participate. I should log on to these things more regularly, so I'm glad I'm here today. Let me, Share screen. Let's get here real quick. How does that look? Alright. Good. See the slides, yeah, great. So, yeah, I mean, you know, we're talking about, MDUFA user fees. I'm sure plenty of people on the call have familiarity, maybe, you know, to varying degrees, but probably mostly people do. You know, the latest

MDUFA 6 draft user-free agreement, so there's still some work to do, was made public, you know, past few weeks. And I think, you know, it's good, as Sean said, it's an important thing, important milestone. If anything, these agreements are kind of an opportunity to highlight, kind of update the core priorities of what, you know, the agencies and representatives of industry, at least, see, you know, as, like, the basic functioning of the device center, what they're prioritizing when it comes to, you know, supporting access to new technologies while protecting patients. So, you know, I kind of always look forward to this. It's more like I said, it's a kind of milestone affirming, okay, the regulatory training keeps on running, and, you know, here's what people are, you know, here's the framework for how we're going to be dealing with it. So, you know, I'll talk about what I think are some of the key takeaways and considerations from what we know. I'm not going to do a point-by-point of everything that was agreed between FDA and industry, but, you know, hopefully we'll talk about

at the end of the day, or, you know, what people find most valuable or interesting. Feel free to interrupt, or, you know, try not to keep this presentation too long, and yeah, keep going. First of all, you know, Just really quickly, as Sean said, I'm the editor of Market Pathways. We cover global MedTech market access, regulatory reimbursement policy issues impacting the MedTech space, and, you know, FDA is one big bucket of that, but not only that, of course, a lot of other things. MedTech Strategist Publication, if you have the inclination, mystrategist.com, check us out. So MDUFA, is, you know, I've been covering these, in some manner since, well, since the middle of the first one, really, when it was called MDUFA MA back in the day, but, it's, you know, these are, you know, for people, it won't take too long with background, may not be necessary, but, you know, these are 5-year cycle agreements.

Where FDA and industry negotiate, you know, basically fees that companies will be paying, to the FDA, and on the other side, you know, commitments that FDA makes when it comes to review timelines, you know, transparency measures, modernization, all sorts of things that might be discussed. You know, and it's kind of… these five-year cycles are like, you know, two sides hash outside. What's wrong, what's right. Reach some sort of agreement on, like, a blueprint, essentially, for industry FDA interactions. And, you know, you could, you know, it's been an evolution over the past 25-ish years with the first 5, you know, we're currently a MDUFA 5, and I'm sure everybody, you know, plenty of people on this call, you know, it's not perfect, there's frustrations with the FDA, for sure, not every process is seamless, but, you know, I think there's a general consensus that the stability, transparency, and, you know, efficiency has

improved as a basis… partly as a basis of disagreements over this period, you know, compared to what it had been prior, for sure. And, you know, but on the flip side, the cost-sharing element has really increased over the years, as Sean sort of referenced. I mean. These funds cover about, almost, at this point, like, half of the device program budget, and if you talk about just the review part, because that's really what user fees are about, pre-market review, not post-market stuff, they're, like, really 60% of the of the review budget at this point. So it, you know, there's an expectation for results from industry, appropriately. So now we're on, you know, MDUFA 6, which is, you know, MDUFA VI is good until September, end of September 2027, so we need MDUFA VI to keep the funding coming, and to keep the commitments coming after that. It was been negotiated recently over, you know, parts of last year and into this year, and what, you know, what we've gotten recently is basically, you know.

came to an agreement in principle. There's a draft commitment letter that's been released, which basically says, you know, here's what FDA's gonna do, commits to, to do. And, And on the, you know, there's also been some additional details and a fact sheet released. One thing that hasn't been released, I just want to say as a general, is the exact You know, there still needs to be this draft legislative language that actually spells out, like, what the fees really are, and what the calculations are gonna be, and some of the dynamics and definitions that are, you know, more the quantitative element of things, and that actually hasn't been released in detail yet, so, you know, there's still some more information to come here.

But, so, for me, the overall, you know, I think it's fair to say that stability over disruption is an overall takeaway from the agreement. There's nothing in here, you know, FDA isn't going to completely, change its, procedures. in any massive way based on this agreement, and companies that are pursuing FDA authorization or updates to their products, et cetera, shouldn't vastly change their, what they're up to, based on, this agreement. You know. performance goals, commitments, you know, largely aligned with what already exists, with some tweaks that we'll talk about. Fees, with some caveats also, are gonna be, there's gonna be a stability to those, it appears, as it's been described, in terms of the fees that are paid. You know, it's been, like, a jarring

period, if you say, I don't know, it's 5 to 7 years global pandemic last year with all, you know, the Doge cuts, the rifts, and all that. So, I think there's a sense that user fees are one thing that kind of kept the bottom from dropping out, maybe, at FDA, and, you know, some stability is… is what's sought on both sides, I think. But it is, simplified, compared to what the current program overall, MDUFA 5 current program has, you know, like, bells and whistles, or I guess carrots and sticks, you'd say. performance-adjusted goals where, you know, if FDA meets its goals early, you know, they can collect more fees, but the goals get more aggressive, but also hiring targets where there's carrots and sticks elements, and they've kind of removed all… a lot of those black and white,

adjustment elements. I think maybe it's causing more complication than preferred, and there may have been various factors there, but they've simplified that element of it, so it's really more about just these are goals, and FDA is going to tell us how they're doing on the goals, and we're going to provide them feedback as industry. You know, that's the agreement. The other… the other sort of wrinkle here, though, is this, what I put in quotes here, America first, variable. New distinctions that haven't been there before, between, U.S. and non-U.S. entities in terms of fee structure, and sort of, how they're paying… what fees they're paying, essentially. So, I put this in America first. I mean, that's the term that was used, honestly, in some of the… in the negotiation elements, referenced in some of the discussions,

And, you know, obviously it does potentially, you know, align with, you know, sort of Trump administration-type priorities more broadly, but the functional, you know, description around this in the documents that have been released so far is essentially, you know, it costs more to provide some oversight to a facility that's not in the U.S. or maybe overseas compared to domestic firms, so, you know, it makes sense to have differentiated fees. So exactly what the dynamic here is actually still to be fully defined, and I just want to be clear, like, maybe this won't be a tremendous distinction, maybe it will be a very big deal, because they have, like I said, the fee, the quantitative elements we're still waiting for. But, you know, for instance, you know, exactly what is a U.S. firm versus a non-U.S. firm? I mean, obviously, filing taxes where you're registered and stuff, but it's a very multinational

industry, you know, where you file your taxes, where your manufacturer products don't necessarily, line up. So how does this, being, you know, defined, I think we still need to see. But the one sense I get is one distinction in terms of the fees. It seems to be suggesting, from what I've seen, is that, small business discount might be one area, which is an important, Element of the, of the user fee, program, you know, where basically you're… if you're a small business, you can share your $100 million revenue less, per… less… per year, you qualify for, like, a 75% discount on a lot of your submission fees. So, like, the 510K fee is, like, $26,000 for standard, but it's, like, $6,000 and change for, if you're a small business. And it seems like they're suggesting maybe that discount, or at least a full discount, will be for the U.S.

firms, and maybe not so much for the non-U.S. firms. There may be some higher registration fees. You know, those details are not totally clear, but I think this is something, if you're possibly in the bucket of Being in that, you know, in terms of where you're based and how that might impact, you know, something to watch and look for these details, going forward. So… But in terms of outside of that issue, in terms of new fees, and on the fee side of things, and we'll get to program stuff in a second, you know, most of it's going to be the same as it is in terms of the types of fees there are, the PMAs, the 510K when you submit, the annual registration fees existed for a while now. The one new fee, and I know it's gotten attention so far, a little bit online and LinkedIn, etc, is this new fee that was mentioned, that was agreed to on

pre-submissions, and it appears it'll be a $2,000 fee on, certain initial pre-submissions, is how it's stated. So, it's unclear what's… which ones, so what are the certain, I don't know. But, and also something that will have, you know, a future, credit mechanism. So pre-submissions right now, I'll get into it more in the next slide, but obviously it's a way to get input, before you submit from FDA about what they're expecting, and they're currently free, and now they're saying it's going to cost, you know, $2,000, but that $2,000 will be credited when you… if you do follow up eventually with the de novo of 510K or PMA, you pay that fee, that would be less than $2,000 you already paid. The only other substantive thing I noticed in terms of the fee structure is it seems like there might be an easier path

path for. the small business waiver for a registration fee payment, that for… for really small businesses, but that will be probably just for the U.S. companies, as I… as I was suggesting. So, but those are details to look out for more details on as well. So pre-submissions, I'll get more into that here, because I think, pre-submissions… It's probably, in terms of the most tangible day-to-day change in the agreement that most companies will feel is the stuff related to pre-submissions, just because it's a, you know, pretty popular program at this point. You got, you know, more than 4,000, really, per year coming into the FDA, obviously a way to get specific targeted feedback from

review staff about, you know, what clinical or non-clinical, whatever data will be needed, expected for your, for your, for your process or your review. It's a very useful tool, and I know, you know, you hear people from the European system pining for such a system, free-type pre-submissions. But, you know, it's used a lot. It does use resources on the FDA front. Clearly, last year, when staffing got a little tight, there's no question pre-submissions, the ability to offer them fully, was, challenged, first before other things. And, so it feels like this fee is kind of being framed in the sense of more of, like, giving companies an extra beat to decide, do they need a pre-submission? The quote I put there, encourage more strategic utilization of the program, is what is the definition… the description for the fee.

And, you know, I even hear on the regular… on the consultant industry side, you know, companies sometimes, you know, maybe do a pre-submission when they don't need it, maybe they don't have… they're not ready to ask the right questions, and they could spend the time, this is a time-consuming process, on something else to provide more value. So, you know, that fee is going to be in there. It's not a tremendous amount compared to the other fees that are in there, $2,000, and it will be credited, but it's a new dynamic. The other element is this faster feedback, in terms of the process for pre-submissions, I know it's also gotten some attention, essentially focused follow-up, pre-submissions. So, you know, it's about a 70-day

Cycle now to, You know, you want to put in your request. for pre-submission to get written feedback and potentially have a meeting. You know, there's like a… typically what the goal is is a 70-day turnaround time, and then you know, you have to figure out, get this input, put it to use. If maybe you need more input, it's another pre-submission, and this is, you know, that takes time. This is designed to, you know, give you a little bit more of a back-and-forth potential, if you could ask a targeted, related follow-up questions to your pre-submissions to get more clarity on what you're actually supposed to do. So that, yeah, so far in the sense I've gotten from people, experts, you know, that's a meaningful addition.

And there may be some other tweaks to pre-submissions about maybe giving you a chance to put it up the chain of command, supervisor will review if you're not happy with, the feedback. The other… the only one other thing I was going to mention with this regard that it gets some attention. in the commitment letter is, the informal communications. So, you know, you could, right now, it's in guidance, you know, send FDA, like, an email, ask them a question. If it's a simple question, and a reviewer may be able to just answer the question and not have to, you know, do a lot of research or ask other colleagues, etc. So that's something that you could do right now. Theoretically, you know, you on-the-ground experts could tell me how valuable that is, but they're going to add that into their sort of online portal. That's increasingly how you're supposed to submit and communicate with the FDA. They're going to add a field for these, like, hey, you got an informal question that we could add?

Don't have to put through this prolonged pre-submission, you know, ask it here. So, something to consider, perhaps, that gets some attention here. De Novos is the other, pre-market program that… oops, sorry about that… That, get some, change in this commitment, in this… in this agreement. Not as, you know, obviously 510Ks are the workhorse of… of the… of the review, of the review process in the U.S, but DNOVAs are important. They provide kind of a regulatory route. for truly novel devices, that don't warrant PMA because of their risk, their risk level's lower. But, you know, the program is, you know, it seems a cool pathway for some digital health, diagnostics, others, but, you know, it's… recent years, the data suggests, you know, fewer than half of devices actually make it through the process successfully, like, get their authorization when they submit their de novo. So that's something, you know, industry kind of came to these talks with, like, let's try to

improve that. FDA kind of, I think, thinks, you know, there's some inherent challenges. These de novo products often don't fit a template like some other products that go through other pathways. But the output of this all is basically you know, they came up with this new… there's a walkthrough meeting now, a new official type of meeting where you make your submission within 30 days, you get, this meeting with FDA to kind of try to get on the same page. This would be in addition to, presumably, you know, you may have already had some pre-submissions to get some input, and, You, but… and you also, there's already something called, like, an informational meeting, where you could, you know, give F…

FDA kind of, here's a presentation of our technology, but you don't get feedback from them. This, I presume, is more of a back and forth that you could have to get on the same page right away, versus waiting for them to send you deficiencies, and then try to backtrack and catch up. So, you know, I don't know how impactful that will be, but that's what was agreed to. Some additional tweaks to the process, I think, that will be clarified. But, you know. I think de novos will, you know, there is interest in improving. I know after, even outside of this agreement, there's interest in improving that process.

coming up with ways, of, of making it, better than 50% successful, I guess. So, when it comes to the historic, you know, long-term, traditional ways of getting through FDA device regulations, 510K is obviously the most frequent one, and PMAs for high-risk devices. It's mostly status quo, as, you know, it's been. 510Ks, they're kind of running it back, kind of an acknowledgement they weren't able to meet the goals. As for the total time it was going to take to submit your product. get an answer. They had some, what I guess, were pretty aggressive, a goal of 112 days starting for next year, but they're not gonna make that, so they're gonna recycle it back, and try again for the next 5 years to reach that goal. PMA is basically status quo.

So, the biggest, you know, the folk… the reason for user fees is really FDA capacity. I mean, it's just not… Congress doesn't give… FDA enough money to operate effectively, which is, you know, how this all got started. Maybe not be the most ideal approach, but this is kind of the reality we have. So the question is, like, how does this overall going to impact FDA capacity to actually do its job? When you send in your submission, are the resources going to be there? you know, the claims and verbiage are this is going to keep things stable, but in terms of the details, from a public standpoint, we don't actually know fully at this point what the, you know, the details are there. As I said, we don't actually know the fee amounts, and thus we don't know what the overall revenue FDA's

Gonna be collecting, over the 5 years for MDUFA 6, and there's various other elements of that, definitions and how… what's triggering these collections, etc. We also don't know what, like, the hiring plans are from… in terms of numbers. That was an element of the current agreement. There's, you know, these specific annual hiring targets that Cedar H is supposed to meet, and there was, like I said, some carrots and sticks related to that. They decided to do away with those, sort of. number targets and just say, look, we're gonna… the agreement is we're gonna hire what's necessary and in the right expertise, and also a focus on transparency. We're gonna report regularly and give, industry the chance to provide feedback in terms of how much hiring is happening, is it enough, etc. But there's no numbers, so we don't really know what the plans are there. And then we don't really know what the baseline is, because last year, as I referenced, you know.

I'm sure everybody knows was, chaotic, historically when it comes to, you know, the Doge, the reductions in force, the forks in the road, etc, and we actually never got a definitive number of, like, how many people left, FDA and the center last year. How many people were hired back? How many people have been hired since? They're definitely hiring. CDRH managers, you know, you see… you can't go a day without seeing them post about a new listing nowadays with… for… looking for new people in their office or division, but we don't really know, like, what the specifics are there. So we don't know where we're starting from, so that's something that I think hopefully more details.

Will be provided, or at least were strongly considered, in this agreement. The other thing I wanted to get to, so, you know, this is all, like, the core stuff, like. like I said, it's how FDA's operating, the numbers, the money, but, you know, there's a lot, a lot of the letters taken up by, you know. kind of frontier issues, as I say here, you know, efforts to make sure that FDA is modernizing to the new technologies, and to updated regulatory science, and to just the overall, you know, context in which devices are being developed. So there was a few of these issues that have you know, commitments in the letter that I highlighted here that I think are interesting. There's definitely more, I'm happy to talk more,

you know, in a moment, but the four that I particularly took away, that's other issues that are, addressed in this letter that might be worth focus and discussion is, one, the Medicare and MDUFA, as I say. Medicare, the word, this is the first time I've ever seen it in a MDUFA commitment letter. Obviously, that's not under FDA's authority specifically, so that's interesting. It's not a new issue. FDA and CMS have been trying to work together for some time on this, you know, I don't know if you've heard, you know, the phrase, the Valley of Death. you know, great, you got your FDA authorization, but you don't have coverage coding payment, you don't necessarily have a feasible product, and that's a bigger challenge in many ways, and getting that, lined up

soon, relatively soon after you get approval so you can actually get revenue is a big challenge that companies face. One element of that is, you know, FDA and CMS try to try to come up with ways that maybe, okay, you could streamline that process so you're… you get some ideas of what CMS is looking for earlier. They've tried this in various ways in the past, parallel review. There's currently the TSET pathway, people might have, heard about. And, but… then most recently, there was announcement of this, what's called the Rapid Pathway, something that hasn't gotten off the ground yet, but is under the same idea. I think this is interesting now that they've really put specific language and a specific goal around

Engage… you know, engaging companies as appropriate, when appropriate, for certain types of technologies with CMS and FDA at the same time. before you've designed your pivotal study, and they're putting user fee revenues behind that to try to make a study that's relevant for both parties. this is part of, specifically, the TAP program, which I didn't get into in these slides, I'm happy to talk about, but I think that's something to look at. The other issues here, I won't go too into detail, but global review pilot, harmonization historically has been a high priority for FDA. They are very involved in IMDRF.

You know, and I think there, you know, maybe there's some questions about the direction that was going last year, too, in terms of engagement on the global stage with FDA, but I really think they're redoubling their commitments in many ways, including in this commitment letter to harmonization with a regulatory reliance and the like, and also a pilot program allowing companies to… company to submit to FDA and to other bodies In parallel, some sort of coordinated review, so that will be something to watch, a tangible thing to follow. investments, personnel, et cetera, and real-world evidence is committed to in this letter, which is obviously, you know, I think a growing importance to how data can be collected for devices, and of course, digital health regulation. I mean, we talk all day about there's so many issues, and that's… so many devices are incorporating software and AI and, you know, creative ways of dealing with that, but also, like, hiring the right experts.

you know, it specifically mentions generative AI and Agentic AI in this letter, so, you know, it shows the times we're in, and I think that's noteworthy and important. And I'll end, you know, here just to say, you know, in terms of next steps, timeline, I won't go all through this. Key thing is there's a meeting in a few weeks, August 5th, public meeting, that FDA convening, where FDA and the industry negotiators will basically present the plan and hear from public feedback, opportunity for people to speak. There's also a written comment period, that goes along with that, basically with the idea of getting everything together so they could send it off to Congress, by January, because Congress ultimately needs to, like, pass

this… agreement, it's a matter via legislation. The one thing I'll say as the last thing is. you know, this is a draft commitment letter, and there's comments, and it's important to engage. What's in this is important, because it defines the framework of priorities for FDA, but I wouldn't, you know, like. it's probably not possible to change, like, the substantive core elements of this agreement, based on public comments, because honestly, this is a negotiated agreement. I haven't seen in the past that very likely, but clarifying it, and adding, clarifying, or maybe adding some elements to it is possible. So it's, you know, it's worth engaging. But yeah, I mean, you know, that's,

That's what I have. at the moment, I think I'm happy to, you know, pass it along to you, Sean, or pass it along to others to, talk more about whatever people want to talk about, if there is more, to talk about, yeah?

I love, I love Valley, Valley of Death. I like it.

That's her, but yeah.

That's, that's… that's an exciting term. I'm putting a link in…

I lost it.

the chat file to everyone right now, put something new you learned from David here. I want you to go to LinkedIn. And I will wait. I will wait. There are 120 of you on the call. That means I want to see 60 comments. 60 comments on the post. that are like, oh, he talked about the Valley of Death. I don't care if that's all you write, but you're gonna write something on there. And, so… or we're not moving on. And I know. I'm, like, the fourth grade teacher. Do you remember that? But the, yeah, so I, I mean, wow, there were… there was a lot, in what you said. You know, realistically, how much of this survives October 2027, you know?

in your…

It's… oh, all of it. That's what I… I was sort of trying to make the point at the end there, I mean. This kind of is… it's not… it may not be the most democratic process, but, there's, you know, there's a months-long negotiation between, FDA and the industry parties, which are currently represented by Advamed and MDMA, and they involve company… companies. And, you know, there's separate meetings where they inform, sort of patient groups and consumer groups what's going on with those negotiations. And then there's this public process, and there, you know, opportunity to provide input and, you know, maybe tweak some things or add clarifications, but in my experience, you know, when they come up with this core agreement.

this is the agreement. You know, now, once it goes to Congress, Now, whether… Then there's the political part of things, of actually passing legislation. We could get into that if you want, you know, but then… and potentially adding additional reforms legislatively. Oh, we… people want to update something about the authority related to digital health or AI, and that could be done through Congress, adding on to this. As a separate piece of legislation. But the core agreement that, that we're looking at now I'd be the honest… my honest answer is I don't think, you know, much would… unless… the only possibility would be, of course, it doesn't go through because

our political system is, you know, not always working swimmingly these days, so something doesn't go through, that, that side of things. But, yeah, so, I see, A few hands, I don't know if she shot a few…

Yeah, Andre, why don't you get us started? Then we'll go to Maria.

Okay, yeah, thanks, thanks, Sean, and David, appreciate the presentation. I'm gonna talk about something that's been a pet peeve of mine now for a number of years. We've been in the business since, when there was no facility registration fee. And then, you know, it started off where they said it's just going to be a cost recovery fee for the inspection time at $1,500, I think was the first year, and now we're over 10,000. And, you know, we're a company that… we deal with a lot of startups and small companies, a company that may have only a single medical device that they put a 510K through. And, you know, now at a, whatever it is now, $10,000 or more, it's tough for a small company. That's a big expense. And my pet peeve is there's… there should be a right-sizing, just like they do with the 510K filing fees and other fees.

Right now, this, you know, a little company pays the same exact facility registration fee as a company with thousands of employees and might take 2 weeks to inspect, where a small company's inspected in a half a day or a day. So I don't think it's fair that small companies pay the same facility registration fee, and I don't know if it does any good, but I keep saying this, and I've been saying it for years, and you just gave me another opportunity to say it, so thank you.

No, I hear you, and it's interesting, because, well, one, I mean, you know, we don't know. I should… I will underscore again, you know, they haven't actually released what the fees are. So, you know, they've made… they have statements about it, but not the actual fees for the next agreement, so it's worth watching to see how this comes together. They… yeah, I think the original idea was We're… we have… we're trying… instead of keep increasing the submission fees, we're gonna get this comparatively lower. across-the-board fee, and that's going to be where our revenue comes from. But yeah, I mean, obviously, different company. There is this waiver for their first registration fee now, apparently, that exists, and apparently in the new agreement, it said you don't have to show a hardship anymore before you would have had to show some sort of financial hardship.

But yeah, no, I hear you. It would be worth seeing what that is, and I also am curious to see how that… this whole U.S, non-US, they might… how they balance the registration fee with regard to that will be interesting to see. But yes, I understand your comments. I don't have a solution or answer for you at the moment.

Maria.

Maria E. Donawa, MD: Oh, hi, thanks. Very informative and a bit scary at times, but…

Sorry.

Maria E. Donawa, MD: Good to know. I can't remember which, aspects were… Maria E. Donawa, MD: possibly going to be different for U.S. versus non-U.S? I don't remember if you mentioned it more than once or once. Can you remind me of where there might be a difference between U.S. companies and non-U.S. companies in terms of charges?

that's… we… the idea that there will be has been clearly part of the agreement. The actual details of that I don't know in detail. The main, Statements that seem to suggest that the distinctions may be primarily with regards to, one, the small business discount. I don't know for sure, does that mean that one entity does and one entity doesn't? I don't want to say definitively, because it's, you know, there's not the numbers there. And also, perhaps, with the registration fee, as we were talking about, there may be a distinction. You know, I… again, the piece of this that hasn't been released is this draft. There's this, you know, the fee part of it, the quant… the finance part, is straight in the legislation in a way that these commitments are not. There's two different kind of… and so they haven't released that

that part of the language yet. So that's what we're waiting for, and I think, to me, that's the key question that I'm looking to be answered.

Maria E. Donawa, MD: Thank you very much.

Elisabeth. George.

So, David, first off, thank you for this update. I can tell you, as somebody who sat at that table for 3 of these MDUFA negotiations. And then was very actively behind the scenes for two of the others. This one I was… have not been as involved in. A couple things that came to mind for me was, is number one, I fully agree with the gentleman earlier that said about the fees. That has been a discussion that we've had repeatedly. Throughout all of the, discussions when it came up about, you know, the, application fees, particularly whether it be even a 510K fee or the registration fee, because of the differences in scope and size.

Because in some cases, those single registration fee for a site could be a very, very large site. And as you said, two weeks, I mean, I personally have posted, 5-month FDA inspection. So, you know, that has always been a discussion. I also was very intrigued to hear the concept of the difference between domestic and international. You know, international, obviously, the FDA having to travel, to those, the cost is significantly burdensome. But I guess it'll be very interesting to see how they decide what is international. Because, you know, a couple of those very large companies, their corporate headquarters is international.

But they have,

Probably.

probably at least half of their sites domestically, located, so that's… that's going to be interesting. The one key question, though, that I do have is, is that having been a participant at the table, I know how contentious some of the prior negotiations were, where there was a lot of, disagreement at the table. It took a lot longer. It didn't seem to be, as contentious this time. Was that because there was limited amount of change, or was it because industry is finally just feels beaten up and isn't getting anything anyway, and the FDA hasn't met most of the metrics. And… and invariably, they meet the metrics for year two, three, and part of 4, and then suddenly fall off, you know, right after the negotiations. I'm just curious from your perspective. And thanks, Sean, for bringing this to us, so…

Yeah, no, it's a great, great, great comments, which I agree with all this, you know, in terms of the questions about the other issues. And yeah, on that, on the negotiations, yeah, I mean, I can't say definitively, I mean, obviously, I, you know, did the reporting I could, and of course they released the public you know, summaries, it did… and it clearly… I agree with you that it… There certainly were plenty of areas of dispute that… throughout the discussions, but it did happen pretty quickly. Much more, you know, it was a relatively smooth process. I don't know for sure. I mean, I think I know that on the industry side, the language was very much like, can we just keep this

As, like, back to basics. That was the word used last time around, but I think they, like, just solidified that this time around, like. we really don't just want to avoid the bells and whistles and just keep it, you know, it's the best it's going to be in some ways, in terms of the foundation for whatever we're gonna do. Maybe… I don't… but I… in terms of motivations, I'm not sure. I mean, one thing that's interesting is, like, I don't think it was… you know, a sure thing that you'd get an agreement, or, like, a standard user fee agreement. Like, a year and a half ago, I would have said, is this gonna happen? Because, you know, the whole RFK Jr. of it all, and, you know, corruption comments and things like that. And so, I don't know if it was, you know, what, what, you know, it was just like, okay, people that were more directly involved say, let's just stay below the radar here and get something together without

you know, capturing too much attention when, you know, it might go sideways, because, you know, there really is a standard, you know, I'm sure there's plenty of things to complain about or concerned about, but relatively standard user fee agreement, and I… that wasn't… I don't think that was assured. Yeah, so… so I think that might have been part of it. Let's just… let's just get this job done, you know.

Great, thank you.

Others would know better than me, who are in the room, obviously.

Craig, you had a question? I'm not sure where you went. I can't see you on my screen, but that doesn't mean anything. If you're still here. We may have lost Craig. Does anybody else have any questions that they would like to raise? There are a lot of, a lot of comments about, try Europe, no discounts for, small, medium business, businesses at all. And, that's going back and forth. Yeah. Yes.

That is an issue of discussion in Europe with the reforms, I know, in terms of notified body. But, yeah.

Has there been any discussion around, that maybe Class 1 devices, especially Class 1 GMP-exempt devices, would get, like, a lower fee? Because, you know, most of those products are, like, almost commodity products. And you guys sell a lot of ear clinger outers for To pay a $12,000 annual fee. You know, it just doesn't seem practical if you look at the economics of it. And how much product that they have to sell to…

Right. Yeah, I mean, it… I did… I don't know that there… that's obviously, yeah, this whole registration fee element. I am interested to see, like I said, I do think there is some reference to some of the fees going down. for U.S. companies. And how that dynamic is, will the registration fee be lower in that sense? But… but yeah, I don't have any word on it, like, exemption for… specifically for Class 1, and I don't think, that was discussed, but yeah, no, I… I think that obviously is a topic of… of interest, but I haven't heard anything. specific to that, but we'll be interested to see if that fee… how that fee is adjusted. That, in general, the registration fee, I don't know what it's going to be.

In 2028, fiscal year 2028 right now.

But, you know, the FDA public written comment period is open until August 5th, so Michelle, I would recommend that you submit that as a written comment before August the 5th, and anybody else who agrees with her, chime in, because that would be, you know, an interesting way To, you know, show that this forum is having an impact, And… you know, possibly influence policy in a small way, I would love.

Right.

Nut.

Yeah, I mean, and I should, you know, I know I was, like, poo-pooing the idea of, you know, what could be changed, but, you know, I mean, there's a congressional part, of course, of this process where who knows what can happen, and But, yeah, so it, you know, certainly worth getting engaged. And I think the written comment, actually, I just noticed before the, the meeting, the meeting is August 5th, and the written comments you can submit, I think, through August 7th, actually, I just noticed, so extra two days there.

Thank you for that. You know, for me, the idea that they're gonna charge money for presubs is, like, okay, they're getting 4,000 presubs a year, now they're doing 4,000, you know, what's that gonna do to that number? You know? And I understand the logic behind charging, but I wonder what impact that's gonna have. on… on, you know, on startups, particularly smaller startups, that they're just gonna… they're… they're gonna skip that, you know? They're gonna hang on to the 2000, and they're just gonna… You know? I mean, I… you know, one of the beautiful things about precepts was free.

Yeah, I mean, the… yeah, and I hear you. I mean, the cred… you know, obviously, right, it's… it is going to be credited, and it'll also be interesting to see what… it's not clear that it would be for every pre-sub, and I have no idea how that would be distinguished, the way the wording is. But yeah, no, that's fair. I think at the end of the day, it is designed as, like, like I suggested. Less as a major revenue, earner, because it will be credited in most cases, but more as a, do you need this pre-sub question? And maybe the answer? Is it worth $2,000 to you? Maybe, you know, maybe sometimes not, I don't know.

Can you put a link to the, the… I guess it's the Federal Register, where we would read it and leave comments?

Yeah, Sean, do you want me to, do that? I could, yeah, good. Yeah, give me, give me a moment on that, but yep, I could… I could do that.

Oh, Carrie, do you have something?

Are the presets gonna be the ones that, once you're in the 510K and you request a preset, are they gonna charge you?

Say that one more time? Sorry, I was…

So once you're in a 510K, and you know you can have a pre-sub once you're in the 510K, are they going to charge you for those pre-subs?

I mean, it's a good question. I don't… like, I… I mean, it's… it's not… the details on the… on when exactly the charges are going to come are to become, and that's what I… because I… and I hesitate to, you know, I'm not sure, because the commitment side of this, this is what they're doing, changing the process, the thief side of it, there's some… a few lines about, here's what we're thinking about, and what I've read in the agreement. But I don't know, yeah, I mean, it's unclear whether every presub will be charged, because it does use this word, certain pre-subs, but I don't know what they're referring to there. I just don't know what the detail is. But that's something that we, you know, will be watching.

To be determined.

Determined, yes, exactly. Yep.

Because they just changed that guidance, you know, and now there's all these different precepts through… that you use throughout the different process.

the QSub guidance.

Yeah.

Yeah, yeah, right. And I think, I think… Yeah, I mean, yeah, I think they are referring to, you know, because the pre-subs, right, pre-submissions is one… element of that, and there's all these other meetings. I think they're talking about specifically the pre-submission meetings, but I… again, I don't want to speak too detailed about it, because I really hesitate, you know, it's unclear whether, You know, the details still need to be, you know, posted, so… And I'm about to… sorry, I'm just getting this link here to the photo.

I just went through a pre-sub after a 510K, and they didn't answer one of my questions.

Well, that'.

Nope.

Yeah, this is the real, this is the real, right, the real, the real, the real stuff, coming from the people on the ground, so… and then, you know, right, I know, I know it's like, oh, it's nice, nice, nice procedures and, and that you have here, but what's actually happening is, you know, obviously you guys, I understand that.

What would happen? Because I've had several pre-subs lately where they're like, we can't or won't answer that question, you need to do a 513G, even when I wrote the question verbatim out of the appendix in the pre-sub guidance argument.

Exactly.

So, like, or they can charge you $2,000 for a pre-sub, and then tell you you need… you need a 513G instead, and it's $6,000. So now you're $8,000 in and don't have any answers.

Yeah, yeah, no, I think that's… right, because the pre-sub is kind of, you're going in. And you're hoping it's useful, right? I mean, that's…

Sounds like Michelle.

be on the next MDUFA negotiation committee.

They'll sit there stone-faced with us, though. That's what they've been doing. I wonder if it's the same division, Michelle.

That would be actually fun for me.

I did post that, that link, but I don't know, it looks… I can't tell if I sent it to everybody, or, or just, hosts or panelists, so I don't know, Sean, if you see that, if you wanna…

I'll copy it.

Yeah.

Yeah.

It went to everybody.

No, it went to host and panelists.

special, so…

I'll be agree.

Oh, okay, so we need participants.

Yeah.

We need everyone to get it.

Yeah, yeah, absolutely. I just…

Speaking of everyone, so, before this meeting started, we were 5 people away from having 9,000 subscribers to MedTechLeadingVoice.com. So, if you're not a subscriber, and you're not getting the free weekly publication, which posts… what does it post? It posts… the best of LinkedIn. So you don't have to waste hours scrolling, but really, you know, our editors come LinkedIn, and we try to find stuff that's really helpful, really useful, really interesting, really timely, and bring it to you all in one shot. then you can just look at it and be like, nope, don't care about any of that, and move on with your day, or dig a little deeper into the things that interest you. It's a… it'll take you right to LinkedIn, you stay on LinkedIn, everything happens on LinkedIn, it's very easy. MedTechLeadingvoice.com.

That's one thing. Next thing is, I am going to be attending, but not just attending, participating in the 2026 Startup Symposium in Philadelphia with MedTech startup. That's Wednesday, August 26th. And I have a discount code, which I can share. So if you want the discount code, message me, discount, and I will share the discount code with you, to save 20% off the registration. If you're gonna be in Philadelphia on Wednesday, August 26th. I hope to see you there. One of the things that I'm going to be doing at this event is. Conducting interviews with, participants, vendors, and speakers.

And publishing, a more robust document after the fact around trying to… trying to attend a live event. and capture some of the energy, and share it with a larger audience, because one of the problems with live events is that they become sort of closed-door, well, if you weren't there, then you missed the whole thing. And it's like, people spend hours on their presentations, you know? Days, even. Preparing for this thing, getting ready for this thing. do… putting all this work into it, and then where does the work go? Well, nowhere, you know, because it was a private event, and if you weren't there, it sucks to be you, right? So, one of the things we try to do

in MedTech Leading Voice is attend events. Last year, like, 9 or 10 different events, and And then… and then, you know, report out, you know, on some of the significant stuff that's happening there, so… I encourage you to look into that. That's all I'm gonna… that's my last advertisement for today, I think. Unless I think of another one. Does anybody else have any comments? I see comments about 9001. What's going on with 9001 in the comments?

Cute! You, that's what's going on! You have 9,001 followers now.

Oh, I have 9,001 followers.

I thought it was a stand… you thought it was a standard or something, yeah.

I was like, okay, what is… what is that? Thank you.

cigarettes.

Thank you, Hente. Very much appreciated. So, MDUFA 6. You know, if we think about it, the stated purpose is more strategic utilization of the pre-sub program. It's a polite way to say there are too many presubs, you know? I don't know. And, I guess… This is… this is subject for, we're gonna do a panel discussion, later on, maybe August, September. We're gonna invite David back, we're gonna have Michelle, we're gonna have Steve Silverman, and

I can't remember the other person that we decided we were going to have, but we would really love to get the voice of industry in there as well. And what we're going to talk about is changes at the FDA, And the practical impact on the day-to-day life of the practitioners, whether they're consultants or they're, large companies or small companies. What is trickling down to the end… the end user, so to speak, and do they care, you know? And then, ultimately, you know, I like to tie everything back to patient safety. You know, this is… this is the… this is the through line, is… is all of this… all of this mighty effort, all of this work, all of this bureaucratic red tape and these fees, you know, what is that… what impact is that having on patient safety? Are we…

you know, just putting more regulations in place, like, you know, to, you know, try to catch up to Europe, or are we, Promoting innovation and, and patient safety. Thoughts? Anyone?

David, it almost sounds like it's a money grab with that pre-sub fees. Is that just to make up for what Doge did, or do you think this is something they're going to back up with support?

I mean, I don't… I would say, I don't know if I told you, because I don't know how much it'll be a money grab in the sense that I think they're… like they said, they're gonna credit it, so if you… they collect it, and then you submit a 510K, they'll… they'll say $2,000 off. I think… I honestly think it's more of a, we're overwhelmed with precepts, signal, and, do you… do you really want, you know, it's more of, like, a little bit of, you know. is $2,000 enough to say maybe this isn't worth it? I think maybe that side of it is more where it comes from. than the money itself, but that's my… that's my sense of… from… from what I see.

So it's like they're trying to raise.

questions. They get such bad questions sometimes that, like. there's, especially startups, they might have two products. The pre-sub was on one product, and they'll ask questions about something that's totally out in left field. So, I think it's probably trying to weed out some of the nonsense and some of the people that are a DIY pre-sub without having any regulatory or quality knowledge.

Got you. Maria.

Maria E. Donawa, MD: The credit aspect is very, very interesting. I mean, I'm sure that a lot of people on the call have had similar experiences with the pre-sub process. We've had a tremendous positive Maria E. Donawa, MD: experience with it, outweighing the negative experiences. But it's very complex, because you need to do your homework, and you need to ask sensible questions. Now, if it's a trial balloon, and somebody says, let's just get FDA's opinion whether we're gonna file or not. Maria E. Donawa, MD: That's where you might catch the people who are gonna do that, because they'll see the benefit if they're actually gonna file a 510K.

Maria E. Donawa, MD: Or some, you know, or some other submission. So it's got a lot of, aspects to weigh, but for us, it's been overwhelmingly positive. Maria E. Donawa, MD: And FDA will answer your questions in general. They'll answer the questions, the four questions, let's say you asked. They'll say, oh, by the way, we also noticed. This is a huge benefit. And then they'll go on and give you an opinion of… on aspects that you did not ask about. Maria E. Donawa, MD: So, again, they're not perfect. Sometimes you'll say, now, what are they thinking? What are they smoking? What's going on here? But over… overwhelmingly, we've had a positive,

Maria E. Donawa, MD: Experience with it.

Oh, Elisabeth.

That's the one thing that I think that maybe this fee was intended, and I know that, a couple of MDUFAs ago, when they started the presub, we actually suggested that there be a fee, and the reason that we did was, I have seen a number of small companies that I've been brought in to consult with after they've done it. And they've attempted to have 5, 6, 7, and 8 different pre-subs. They submit stupid questions, as Ms. Seryl said. They… and they try to do that, and I think Adding a fee to it says, let's… let's… Are we making a good decision to even ask the FDA? Are we having, true questions, not, you know, do I need a 510K? You know, stupid questions. And I think that, you know, the challenge the FDA has is that if a company submits 4 or 5 separate

questions, and they either don't have anything to do with, or, you know, nothing comes out of it, then, you know, they've spent an inordinate amount of time on that, where they could have been spending it on an actual submission. So there is value in putting, you know, it's kind of like if you think about some events, the reason they charge a small fee is so that, you know, to know that people will show up. Well, this is an opportunity for the FDA to say, you know, hey, stop submitting all this bluff, because if they're getting 4,000, I know that when we first started the whole discussion of pre-subs, I don't think any of us thought there were going to be that many.

And it is time. Even if it's a simple question, it is time. Somebody has to read it, somebody has to respond. It's not always a meeting. You know, 90… probably a large percentage of these are done via email. and then the other question I guess I would have, David, that I don't know if anybody's thought of is. Who decides which one of those pre-subs goes with that specific submission? Is it the submitter, and they suddenly say, I did 4 pre-subs, and these all apply to me, even if 2 of them really weren't, or is it the FDA that gets to decide?

That's an interesting question, yeah, and I don't know the answer, but yeah, that's…

So, we're gonna wrap things up. I want to, thank David for his time. I want to thank all of you for your time. I saw, like, 120… Five people online at one point. And many stayed for the whole session. If we didn't get to your question, please drop your question, in LinkedIn in the… in today's post, and David and I will try to follow up with you. I want to remind everybody that next week, our very own Andre Di DiMino designing electronic medical devices that actually reach production, because apparently not all of them do. And he's gonna tell you why. I think, if you know somebody who should know more about contract manufacturing and doesn't, invite them.

You know, that's really the role of this group, is to say, hey, we're bringing together these people that have these varying viewpoints and experience, and this is not something you're going to get from ChatGPT. So, on that note, I hope you all have a great weekend, and I hope that next week my voice will be back to normal. Thank you, all.

Thank you.

Maria E. Donawa, MD: It's great.

Thank you.