FDA Ground Truth 2026

Hello and welcome, everybody. My name is Sean Smith. This is MedTech Leading Voice, and… I'm looking at the wrong page. Welcome to FDA Ground Truth 2026. As we wait for everybody to join the call, I'm gonna run through a few, housekeeping notes and announcements. So, what do you need to know? I'm gonna start with the announcement. This Friday, join us for testing software to prove it works with Chris Kelly of Keystone Medical Device Partners. next Tuesday at, the 29th at 11 a.m. Eastern, Sex Bias and Medical Device Usability Testing. With Claramet and DNV. Then, Wednesday the 30th, 12 noon Eastern time, Device Innovation to Commercialization with Renee Franz, and our own Michelle Lott of Lean, R-I-Q-A. Wave hello. Please.

Francesco is going to be dropping these, registration links into the chat. Anna and Francesca, my colleagues, will be, Monitoring the chat and the, Q&A. Then on, October 2nd at 11 a.m. Eastern Compliant and Still Wrong with Steve Gomberts and Jean Bloom. Your risk file can pass audit and still be wrong. So the housekeeping announcements. This webinar will be recorded. is being recorded. Slides and recording will be made available to everyone who has registered, so, that's a nice thing. Questions to the panel go in the Q&A box.

the one marked Q&A at the bottom, and, anything else you can put in the chat. If you'd like a certificate of attendance, please put your name and email, name as you'd like it to appear on the certificate, and email in the chat file. We'll be running 3 polls during this session. Please participate in the polls. They're gonna help you, and they're gonna help us understand what's going on for real, for real, in the FDA world. And… When you, see a keyword on a slide, type it in the chat, because the speakers have, you know, various things that they're giving away, like, you know, their newsletters, or downloadable

things, that you're gonna want. So, look for those opportunities during the thing. One more thing, if your company wants a sponsored webinar with MLV, please just write sponsor in the chat, and I'll set up a call. Now, to today's…

So, can you… can you please add me and Anna as co-host?

Okay, sorry.

Thank you.

show today's speakers, Steve Silverman, chairs today. Steve, previously led the Office of Compliance at CDRH. He's a consultant. Michelle Lott of Lina QA covers QMSR inspections and this year's 483 data. David Filmore of Market Pathways is going to talk to us about MDUFA 6. Bill Desjardins of Arnold & Porter. covers warning letters, 43 responses. Angelina is going to talk about her experience, at companies large and small, representing her own viewpoint, of course. And, Jeff Lipps brings 40 years of regulatory and quality in small companies. Before I turn it over, disclaimer.

The opinions expressed here today are those of the speakers and do not represent the companies or organizations that they work for. With that said, I'm going to give it to Steve. Sorry for all the words.

So, do you want me to jump in?

Sean, I don't think we're sharing the slides, at least I can't see the.

Yeah, me, me also.

We are now seeing your screen, but not your slides. There we go.

There it is.

Sorry about that.

That's okay. So, Sean, I am really happy just to speak generally about this slide. I have a marker on my own notes indicating that we, would kick things off with me, talking at slide 5, but if you want me, if you want, I can just speak to this slide generally and cover the points that we discussed previously.

No, I'll just… advance to the next slide, if I can figure out how to do that.

I think we want to work towards slide 5, if I'm, tracking correctly, or yeah, slide 5. Unless there was a polling question at slide 4 that I, believe you might have wanted to ask, and if you want to do that first, that's totally fine.

Okay, so here are the, subject matter experts that we have today. Sorry about that. A little, discombobulated. Just some notes here. And we're gonna run the first poll question, so I'm gonna go to… Why is this… there it is, more… Polls and quizzes. Launch. Sorry. Okay, so here's the first poll question. Which, as you can see, is…

Yeah, who handles the regulatory work where you work? Tell us about your team. And, while that is happening, I'm going to advance to the next slide, and let Steve… Take it away. Sorry.

Yeah, it's no, no, it's no problem at all. So… Thanks very much for including me. I'm going to talk about a couple of things. I'm going to talk about the genesis of the session that we're having now, and then I'll talk to some of the points that are on this slide. This is a great opportunity, I think, in terms of the genesis of this presentation, and the way that it came about was that, I was talking with Sean and Michelle, Phil, and others, and saying, like, look, there's been just an unbelievable amount of information regarding FDA over the last 18 months. There's been huge changes at the agency, and it would probably take most of the session

For me to recount all of those changes in any kind of detail, but… Everything from… exits from the agency, a commissioner who came and then left, a new acting commissioner. lots of congressional attention, and one question that occurred to me was, like, okay, for med tech regulatory professionals, how much of those issues do they really need to be paying attention to? And given the current state of CDRH with Relatively stable and impressive leadership. from the center director, in particular, what's happening in the center that med tech regulatory professionals should be looking at. And so, Sean and I began talking about that topic, and that was the genesis of this session, and the idea was basically, okay, let's bring together

really smart people who are the people who have been identified in this session, to talk through those issues, really with an eye towards devices and med tech. So, less of a high-level discussion about leadership-level changes in the commissioner's office, things that are going on with HHS, and more about what's happening in CDRH, And what it is that med tech professionals should be considering. And a lot of those salient points are reflected on this slide. There's no reason for me to go through them point by point, and I'm not going to. But just to highlight a couple of the major events that have happened over the last, say, 18 months, we have a completely new regulatory construct

for how FDA is evaluating device company compliance with regulatory requirements in the form of the QMSR, and there is alignment between FDA's previous quality system regulation and the quality management system regulation. I don't want to get Too much, into this particular topic, but it's a massive change, and it's one that have… many, many people have been talking about, and it requires attention. It's also worth paying attention to FDA's announcement of the Rapid Pilot Program, and I wouldn't say look at… look at Rapid exclusively. It's a really interesting program and deserves attention.

For me, I think what's more interesting about it is that notwithstanding the massive change at the agency and the loss of staff, including the loss of staff at CDRH, The center is able to continue, in addition to reviewing device submissions, also initiates some interesting pilot programs, like Rapid. The Center continues to produce guidance documents, like the recent guidance documents. On, evalu… on… excuse me, I'm… I'm… Just trying to recollect the topic, but the recent guidance documents, that the agency put out On, tech topics. I'll get specific titles in a moment. The point is that the Center continues to push guidance and initiatives. At the same time.

as it's reviewing submissions from device companies. But then the question is, okay, what does that constitute? CDRH is meeting its MDUFA commitments, certainly. So if you look at MDUFA 5, CDRH has done an excellent job of meeting its commitments in that, package of agreements between it and industry. At the same time. there are certainly slowdowns, that the center is experiencing while it meets its MDUFA commitments. So if you look at the slide, authorization times are up for PMAs, certainly. Also for other submission types, like 510Ks. And de novos, and the impact of…

The increased time that it's taking the center to review various application types is something that we may be seeing now that has an unfolding tale, even though the Center has done a good job of meeting the associated timing commitments that are captured in MDUFA 5, and then will, to a certain extent, come up in MDUFA 6. The last thing that I will point out is Gen AI. Gen AI continues to be an absolutely huge topic. CDRH is grappling with digital innovation and how that is affecting its regulatory structure. Is something that is absolutely essential. So, on the one hand, CDRH is not departing from its core principles that devices need to be safe and effective.

At the same time, given the radically different ways in which Gen AI and other device technologies work, the Center is looking at very, very closely at whether regulations that were developed 50-plus years ago need to be modified to accommodate technologies that exist today that weren't even considered when the regulations were drafted. What's great about those conversations is that many of the discussions are involving external stakeholders, so CDRH, I think, accurately recognizes it doesn't own knowledge in this space. It needs to work with a lot of smart people inside and outside the agency to get to the best version of the right paths forward. Sean, let me pause there. If there are other topics that you think are worthy, that's great.

Let me just kick things over to Phil. To talk more about this and related topics.

While we're at it, I want to just mention that Steve writes about the FDA weekly. If you'd like to receive his free Substack, it is a Substack, or newsletter.

It is on Substack, it is free, and I'm happy to…

in the chat, and we will sign you up.

Thank you very much, Sean.

Thanks, Steve. Steve, that was a great overview of what's been happening over the course of the last year. We've got another 75 minutes to get through everything. We're going to circle back to many of those topics in a little bit more depth, and discussion on each of them. But I think it's impossible to have a conversation about FDA and CDRH in particular in 2026 without talking about the biggest and most massive change that the Center's undergone, probably since its inception. I think we just celebrated, and I think I know we just celebrated the 50th anniversary of the medical device amendments of 1976. So what I'm referring to is the pretty significant reduction in force, reduction in resources, in the spring of 2025.

We've got some numbers up here. One of the challenges when we're talking about the changes that were impacting the spring of last year is that there's no sort of single or official source of truth as to what the scale of that impact looked like and what it was. The last number we had was about 2,200, or a little over 2,200 CDRH resources at the end of 2024. I've seen numbers, percentage-wise, between 20% and 24%. I think I heard Dr. Tarver speak in Minnesota about 6 months ago. She used the 23% number. However you slice it. there's no way to ignore the fact that CDRH lost somewhere between a fifth or a fourth of its total resources over the course of the last two years. And we talked about all the policy changes, all the statutory and legislative changes, new guidance documents that roll out, that make changes to individual, sort of, policy areas.

those changes don't impact nearly… the center nearly the same way that it does with that reduction in resources. And while it's absolutely true. that traditional reviewers, people that sort of identified under their HR code as medical device reviewers, or even sort of managers in that reviewer chain, were not necessarily directly impacted by the forced reduction in staff. There absolutely has been an impact to the efficiencies, the timelines, even to some degree, the policies that CRH is executing across the center since that period of time. The best way that I think about these changes are, and again, if you were to hear FDA sort of talk about where those impacts occurred, they largely happened in some of the organizations. Think about the communication staff, the management staff.

some of the budgetary executions, the FOIA offices, again, not reviewer company sort of facing functions. But what we often leave out when we categorize things in that way is that these functions, these responsibilities didn't themselves go away. So when you think about what was happening in CDRH a year and a half ago, the communications, the travel, the management aspects, they were being done by somebody. And when those people leave, it falls upon the scientific reviewers to pick up that slack. So now you've got a workforce or review team that isn't 90% focused on review times and individual files. Now they've got to split their same 40, 50, 60-hour work week across not only their reviews, but also those sort of shared services that… or now that are shared services, historically, that we're sort of delegated at.

They'll get it up. It's a long way of me saying there has been impact felt across the center. When we look at the MDUFA report outs, how is FDA meeting their overall MDUFA commitments, one of the good things is that there are actual reported outcomes in terms of how quickly are they clearing 510Ks, how quickly are they responding to de novos, pre-subs, all those things are still technically meeting the MDUFA commitments. We haven't seen huge drop-offs in those time commitments. What those numbers fail to account for is, what's the level of interaction? What's the level of substance that comes out in those submissions? And I've got one specific example that I think is the best way to illustrate the impact that we've seen.

When I think back to 3 years ago, prior to 2025, when a company of mine would have submitted, or a client of mine would have submitted a 510K that was going to receive an additional information letter. Basically, it didn't have all the information in it that FDA would expect to see, or that it would need to ultimately clear that 510K. Let's say there were, for example, 3 deficiencies identified with that 510K. What I would expect to have seen in 2024 was all three deficiencies clearly identified, with a significant level of substance supporting each of those level of deficiencies. It would come through an AI letter, the company would then have however much time is left on the review clock to respond, and hopefully they come back and provide the appropriate level of testing, analysis, explanation, justification, whatever it might be.

But they've got the right information for how to respond. In 2025 and 2026, what I've noticed is those same three deficiencies are being identified appropriately. Company knows, what those deficiencies are, but the level of detail supporting each of those is missing. What I found CDRH staff, because what I believe is they've been triaging, they've been trying to figure out, alright, how do I get through all the work that I have to do with less resources? They're coming back and saying, alright, deficiency 1 is the most significant, the most substantive, the one they think is going to be the most challenging.

for the company or the sponsor to respond to, they're providing 95% of the same level of detail. But for deficiencies 2 and 3, they're providing a very cursory level of review. Quite frankly, from my perspective, it feels like they haven't had the full amount of time either to fully understand those issues, and maybe that's the lesser extent, but maybe just to sort of document. They're on such a review timeline and a review crunch. that they're identifying those issues and not providing the appropriate level of detail that I think the companies need to fully respond to that. And that results in maybe an additional Q-sub or pre-sub, a substantial interactive meeting, additional mechanisms that are necessary to respond to those pieces. I don't David or anyone else on the panel, any thoughts on what we're seeing with this reduction in resources?

I will… I will make a comment here that, you know, and I wonder if people in the chat, do you guys know how many, typically, submissions of FDA reviewer, not on the panel. Has to… has to review at one time. Get an idea. Put some numbers in the chat. I want to hear how many. I only see two numbers so far. Take a guess. So, someone said it right here. Around 5 to 12, 15, at one time, a reviewer is reviewing 510K submissions. We have to take that into consideration. on what they have experienced in these past two years, as well as what we're seeing on both sides, right? The pendulum is swinging both ways.

For industry, as well as those in the agency, and they're under an immense amount of stress to perform. That's… that's my experience, but I just want to acknowledge what they… they have endured these past, kind of, two years, almost.

Yeah, and I wonder if any on the call, or if, you know, noticed, has it, you know, obviously there, you know, clearly, as these losses were, were coming, there was, you know, clearly a need to triage, as you said, maybe showing up in things like the additional information letters. you know, has there been any, like, sense of stability? Because I have… I've been actually struck as an observer, and I, you know, want to identify myself as more as a close observer than in the rooms with clients with FDA, that, you know, it's been actually more stable than I expected, you know, and looking, you know, knowing specifically at CDRH,

When it comes to, you know, I think maybe looking at… well, we've mentioned Dr. Tarver a few times, the fact that she's still leading the center, and there's some deputies that remain, you know, really much different than the rest of the FDA, where everybody's changed over. I've had a sense, like, there's… there's a real, like, you know, people… there was a… there was clearly a drop-off, and there's been a push to… to… to make things as stable as possible. Is that… have you noticed any ups and downs, or has it been more just, like, it's been a drop-off, and now you're waiting for… you know, waiting for things to pick back up in terms of these details, in terms of these signs, because I know, obviously, like, the goals themselves are being met.

David, I think we're already starting to see the pickup a little bit, so I think stability that Dr. Tarver's brought to the center has been incredible for the device industry. I don't think it's been as stable… I know it hasn't been as stable in some of the other centers. There's two things to note here. The first is just morale was rel… was relatively, was significantly down, particularly middle of 2025, end of 2025. I think we're starting to see that come back. I think we're also seeing a stabilization in the resources that are there. We talked about a loss of 23 resources. I don't have exact percentages here, but I'd say about 3 quarters of those were people that were RIFT and never came back, but about a quarter of those resources that were lost were people that were just unsure about what the future of their role was going to look like. These were senior leaders at the center.

And they poked their head up and said, well, I don't know how stable my job is, I don't know if I'll have a job 3 months from now. So I'm going to start looking across industry. Those people left technically voluntarily, but I don't think they would have left but for, the push in 2025. And I think we've seen some stability with that. People that were looking… I know we've seen people like Annie Saha leave in the last, sort of, 3 weeks, or last sort of month, but I haven't seen a huge drop-off of senior leaders sort of leaving in the last 6 months. I also saw the first promising sign, so since fall, spring of 2025,

FDA's been talking a lot about, hey, we're actively hiring, send your resumes in. I saw a LinkedIn post from Dr. Tarver about 6 to 8 weeks ago, where she welcomed sort of the first class of, I think it was about 25 new hires into the center. That was the first signs of hiring into Cedar H that I've seen in a while, and even though it's going to take a number of months for those reviewers and those people to get up to speed and to be fully trained, to me, from both a pure resource perspective, but a morale resource perspective. Seeing that infusion of new resources, new blood into the agency and the center, I think has probably picked up as well, so I hope we are now on the rebound and the upswing of what I've identified previously.

Yeah, I think that'll be the key thing, because they are hiring, how many… as you said, we don't know the exact numbers of who left, and how many have been hired, but it does seem like that'll be the key thing, and also how that onboarding and training goes. Do they have the resources to make… because that's always the challenge, of course, you get… part of that training is the new reviewer is on the file, and does that impact your additional information letter, etc? And so I think that'll be something interesting to watch. That's what I hear, you know, when talking to people.

I want to emphasize, and just to jump in for a moment, I really want to emphasize David's point. I feel there's no question that the trajectory is promising. You're absolutely correct about that. At the same time, David raises some really good considerations, and it bleeds over into some of the points that you made. Cdrh was significantly damaged by administration cuts last year and this year. Maybe not as badly as other parts of the agency, but certainly damaged with the loss of line professionals, including seasoned professionals. Now CDRH, as you know, is in rebuilding mode, but that rebuilding mode

I think, based on what I'm reading and based on my own experience, is gonna take years, right? So it's gonna take years for CDRH to bring enough people back in to regain capability. to replicate where it was when the administration began cutting last year. And if you look at certain parts of the agency, of the center, rather, like the Digital Health Center of Excellence, and some of the other, operating components, they have been badly hallowed out. And yes, they are in rebuilding mode, but they are not there yet. And so, I think what that means for listeners is great. definitely be optimistic and supportive for efforts by CDRH and the agency generally to reinstate capabilities that were removed at the start of this administration, but also keep a very close look at whether the influx of new hires and the reinforcement of staff is producing the same capability that existed previously.

Or whether there are significant gaps and lags that need to be accounted for.

Great. We need to move on to the next section, which is QMSR, but if you, so if you've been inspected since February, 2nd of this year, please type yes or no, or scheduled. And also note that, Michelle, who's going to be taking on this section, does coverage of QMSR, and you can get that information just by typing QMSR into the chat. Michelle, over to you.

Okay. So, I think one of the biggest, misconceptions in industry is that a lot of companies thought, well, if I meet ISO 1345, I don't have to worry about QMSR. And that's not entirely true, because there are, 4 to 5 specific sections that FDA expects to follow the new QMSR actual regulation, outside of ISO 1345, where they didn't fully harmonize it. They also, I feel like industry is underestimating the impact of these concepts for risk-based approach and culture of quality, and those are going to be the areas where I feel like industry is kind of taken aback.

We've already seen, some trends around risk-based approach, and people… and inspectors starting to write that up. Which we'll cover here in a minute. And then management review. They have the full open kimono to management review, internal audits, supplier audits, things that they couldn't view before. And so now your management review is going to be scrutinized, and then what they'll do is, if you have a failure in multiple areas downstream, or in your quality management system, and then they didn't feed up into your management review, you've got a problem with risk-based approach, but now you've also got a problem with your cultural quality.

So, those were two… those are two big ones. You know, there are other, kind of minor things that don't… you don't have to have the independent reviewer anymore. I think also ISO 14971, they're very specific that they don't harp, recognize it, or… or harm… that they're not trying to harmonize to 14971. It is a recognized consensus standard, but that, Sorry, I lost my train of thought. Oh, so, but they're like, whenever you're talking about product risk, especially in the QMSR, they said, yeah, we're not, Recognizing 14971, we're not codifying it, but you know what? If you want to know what we think about it, think about risk and how we're going to inspect you for risk, you need to understand ISO 14971.

Another big thing is the definite definition for a complaint change. It added the usability in there. And I think that that… the focus on usability and human factors, we're already seeing, a more… a trend in that for, the pre-market reviews and submissions. The FDA wanting to see more out of that, and then now they're going to be expecting to see more out of your, usability considerations and your design changes in your, the way you evalu… you evaluate your complaints and document it. So, and that, I think that's the pretty good… oh, the other big, big thing that, we're still kind of seeing how the fallout is that the terms design history file and device master record really no longer exist, and they… they have become one.

And now they are the medical device file. So you need to make sure that, you define somewhere in your quality management system, in your quality manual, or in your design procedures. that, where you acknowledge that the DHF and DMR are now the medical device file, so that you don't have to necessarily change it everywhere and change your understanding of it. So… Okay, Sean.

So, do any of the rest of the panelists have any comments on what's happening with QMSR that you would like to add?

From a small medical device perspective. Many of those companies that are out there, as Michelle identified, believe that they have met most of the requirements already if they had been previously inspected under the QSR or are part of the MVSAP program, so that the changes that they had to make were minimal at most. Michelle has pointed out what some of those changes that typically do not get integrated are. Management in many small medical device companies don't really understand the difference. To them, it's they've added an M to QSR, you know? It's not a big change. So… many of those small companies are going to be reeling if and when FDA shows up.

I think that you nailed it, Jeff. I really think what has changed is the expectations. are now more clear of what they meant in the QSR. So, yeah, you could argue that maybe something it didn't change that much from ISO 1345, but boy, the FDA has got a lot more areas with a lot more detail that they can set expectations and write… operate people up against those expectations now.

Mission? Do you want to just do a quick comment about the preamble? I see a good question here. Any insights on their techniques asking questions during the inspection versus Q-SIT? Just touch about the preamble they sent out and, you know, how that's a valuable resource.

Yep, so, it was very interesting when they finally published the QMSR. It was about 110 pages, and 100 of them were all about the comments and expectations and feedback from industry, and it's very enlightening. Because that's where you really see, what the FDA intends to incorporate, and ideas of what they're going to focus on in their inspections. And so it's like reading, the cheat sheets, if you will, even though they're twice as long. like your Cliff Notes, but, they're really important to understanding how to interpret things, because even when the new inspection model came out for QMSR,

It referenced, it went back in 2 or 3 different places and referenced the QMS, the preamble. So, the preamble is just as important, if not more important, than the actual, Codified regulation itself.

And I think… Sorry, Sean. I was just gonna say, like, for me, Michelle, and Sean, I'll leave this to you, a really critical and tangible discussion point is the one that is, communicated on the next slide, which is FDA's tremendous emphasis on risk, knowledge, and sensibility, and so I just want to suggest, Sean, whenever you think it's ready, maybe we talk about that topic. If you think that there are topics that we should talk about beforehand, I defer to you, and of course defer to you, Michelle. I just think that the discussion of risk and how it differs, from FDA's risk, application, if not stance, under the QMSR, touches on the points you're raising, Michelle, touches on Jeff's points about what small firms may not be perceiving, etc.

Hmm.

One additional change that has impacted small medical device companies as well, and that is the companies that are not ISO certified, where you have auditors come in, they can look at your supplier files, they can look at your management representative minutes. Now those small companies that aren't ISO certified are going to have to open up those drawers that have been closed in the past, and FDA is going to be able to look at a lot more information than they had in the past.

So, there were a couple questions, from the audience. One is, how are changes to QMSR translating into the MDSAP audits? I don't know if that's beyond the scope, but I'll throw it out there.

I don't have the answer to that, but I think that's interesting, because, like, the point of the fundamental point of the push to the QMSR is a lot about harmonization, right? And so I wonder more… even more broadly, is like, is that showing up? Is the… are companies seeing any ease? in, like, when they're getting 1345 audits and other for other jurisdictions, but now they have the QMSRs, they're more, harmonization that they're able to benefit from at this point, or in their work on this front. So, I don't know, that connects to that broader issue, and something I've been wondering about.

And…

on that, note about MDAS app. So, they had to update the audit model, and they had to take tasks off and add tasks in. So you, you do need to review, your, you know, your, your policies and procedures, and make sure that they are still aligned with the tasks In, in the, in the audit model.

There was also one other question for Michelle. Is the DHF, the design history file, equivalent to design and development file? I don't…

It sounds like it, So, it's because, you know, now under… you have your device history file that was, like. your, your… all the history of how you developed your device, and it used to be that the DMR was almost like… so, like a cookbook, like where you go and get the recipe, and the DHF was, how did you even get the recipe? How did you get to that point you had the recipe? So, I would have to, like, see your procedures and how you've defined those terms, but it does sound like the DHF could be the design and development file if it has the whole history of… in it.

Good. So, this is what Steve was referring to here, is risk is now the number one thing FDA writes you up for.

Yeah. And I'll add one thing, and I'll put it in the chat, Sean, and maybe it could be copied over, but MDSAP just created a new website, and they uploaded, to your point, Michelle, some more recent documents in early August, so I encourage everybody to to get that link there, it's mdsap.global backslash, or .com, and then you can find documents section, where you see those updated documents and guidance documents that they've published there, because it's no longer on the actual FDA website, they point to a different website.

Thank you for that. I put it in the chat for everyone.

I would just flag briefly, I think seeing risk as, two new entrants to the top 5 or top 6, observations being identified is not, not surprising, given the focus of, the new regulation. What I would say is we're still seeing, like. we're not seeing an influx of new warning letters on new issues. In my experience, new observations are great, it's putting companies on notice, gives companies an opportunity to respond and maybe even update their procedures to better reflect risk assessment. But what I'm not seeing just yet, at least with my clients, with, I'll say, limited sample size, people come to us when they're in crisis, but,

we're not seeing the intake or the flip from observations to new warning letters in this space. In my experience, clients that are getting warning letters today and over the course of the last year, it's the same types of issues, the same types of problems that would have been getting warning letters over the course of the last 5 years. It doesn't mean that risk isn't being identified in some of those warning letters, but I don't think it is the trigger. It's not, hey, we've got a new regulation, we've got new requirements, so now we're holding people to higher or different standards, I think FDA is appropriately sort of rolling this out, putting companies on notice.

I think this will change over the course of the next two years, as companies should be getting more and more experiencing here, but what I… it's a long way of me saying I don't think the bar in terms of where FDA is raising it from a 43 observation to a warning letter has significantly, if at all, changed since the implementation of QMSR.

So, this… this is… kind of gives you the inspectional history of, FY2026 to date, compared to that in 2024 and 2025. Pretty much every year, year over year, you've got these 5 top things that receive 483s. Kappa, design controls, complaints, purchasing, and production. And they may change order from time to time. But now, we're seeing a shift to that risk-based approach in the product risk management. That is indirectly, you know, validated by 14971 procedures, and we're starting to see the risk-based approach towards the quality management system start sneaking in, too. And I even saw warning letters that were issued after February to companies that specifically said, we expect that,

that you… while your audit was conducted, or your inspection was conducted underneath the QSR, that your responses incorporate the QMSR. And also, they were hot right out of the gate. I know 2 or 3 people, clients, and I saw somebody, point… make a comment here. They're coming out of the gate hot. They're coming out with You know, their new inspection model, they're coming out with, you know, either they're seasoned and they're extremely experienced, or they're young and they don't really understand what all the language and requirements are, so they're checkboxing. So it has definitely been a…

a, interesting experience to have. You know, I had an audit one time where, the audit… the auditor disagreed with the audit risk in the file, and he said, well, you haven't had complaints, why didn't you lower it? well, the risk to the patient hadn't changed. And then vice versa, I had, like, a very small data set where we only had, like, one thing, and he's like, well, why didn't you raise the risk approach? So it's, it's kind of, you know, it's kind of like everybody's trying to get their feet underneath them.

So, just… is it okay, Sean, if I ask a quick question about the previous slide? If we're tough… if we're stuck on time, I'll follow up later.

Yeah, I'm gonna, I'm gonna, I'm gonna run the poll. Go ahead and ask the question.

Okay, so Michelle, here's a quick question for you while Sean is running the poll. One of the entries on the previous slide reads that risk-based approach does not apply to the… to QMS processes. Like, I don't… I'd love to hear your thoughts about what that means. Like, if somebody said to me, okay, explain how I apply a risk-based approach to QMS processes. I would answer with lots and lots of words, and I'm not confident that those words would actually add up to much. So, can you talk about that?

Yep. I got a chance to talk with one of the inspectors for my clients about that, and he said that, you know, if they go for, say they go to your Kappas, and they see issues, or they're not getting done on time, and no verification, etc. And so you have a breakdown in your CAPA system. Then you go to complaints, and you see, well. Boy, we missed our reporting timelines for 3 complaints. And then they go to another system, so on and so forth. Then they go to your management review, and then they see your management review was inaccurate because it didn't pull all of that data in that indicates you have got a broken quality management system that's not feeding each other.

And so, at that point, where your systems are disparate, and they're not giving, they're not interacting with each other, you're missing important things, then that's where it rolls up. You have a culture of quality and a risk-based approach problem. If that makes sense.

It does make sense, I think that one, and I'll shut up in just a second, I apologize. One… point that your response really raises is that what I have seen, read, etc, with respect to the QMSR is that there's huge emphasis on FDA's part and on the part of other auditors, about systemic integration and views, of risk and other quality practices. So it's no longer, okay, are you doing Kappa? Correct. It's, okay. how does CAPA interrelate to complaint handling, interrelate to supplier controls, and to relate to management oversight, and systemically, are you administering those systems in a way that, reflects and responds to risk?

So I just think that's very, very interesting.

Yep. Daliator.

Are we ready to move on to MDUFA?

in our whirlwind tour of FDA topics. Yeah, I'm happy to jump in.

So he created a scorecard, it's really pretty, it's beautiful. If you want the scorecard, please type MDUFA into the chat, and we will send you the scorecard.

Yeah, it's kind of an infographic picture of things to look at within the most recent, MD Physics Agreement, which, you know, just, just, just industry and FDA just came to, and really, you know, every five-year, very important thing, really calling back to, what Phil was talking about earlier in terms of resources, in terms of personnel, that's really what this is really all about. Like, I'll get to some of the, you know, interesting little tweaks here and there that we'll talk about here, but I think, you know, the theme of any user fee agreement, which, you know, will be coming for this next one in next fall.

is, you know, CDRH having the resources it needs, having clear goals, and mechanisms for measuring and, like, reporting out on those goals. That's what this is really about, and I think the focus of this agreement is very much about stabilizing, you know, really connecting, as I said, to, like, the beginning of our conversation. There's, you know, there's a few interesting things here, and there's… but not much out of left field in this agreement, because I think the real focus is in stabilizing workforce. trying to keep resources, you know, consistent, and keep hiring happening, and getting back to maybe what FDA thought was pretty much a good thing before

You know, the 2025 events, while improving the consistency of decisions and approaches and across the entire center, improving that, and, you know, adding some various, you know, obviously helping fund priorities. that the Center has. There's nothing completely life-changing in this agreement. The idea, really, I wrote an article recently called Boring by Design. I think it's really about trying to get things, you know, moving again, you know, apropos to our conversation towards the start of this session. But, you know, there are some, specific, elements that are worth calling out that I think have… will have a, you know, tangible relevance to, people, that are trying to, you know, get their projects through the FDA. And the first one, you know, that we, you know, spotlighted on this slide is the pre-submission… or pre-submissions and the pre-submissions program, which is, you know, extremely,

you know, popular, obviously, way, of companies getting, early input from FDA about, you know, data collection or expectations for testing, etc. And that is, you know, there's, as I mentioned on a call a few months ago with Sean, there's like. you know, 4,000 plus of those a year at this point. It's a very, involved program, and I think there was interest in, making it… adding some efficiency and adding some tiered elements to, you know, it could be… it's a good program, it's helpful, but it also can suck a lot of time, out of, both FDA, suck resources, you know, using for pre-submissions, and it takes time for the company, so making sure, like, you're using a pre-submission, that it's worthwhile, and that there's ways of maybe getting a

quicker feedback in some cases. So, the big thing that got a lot of attention, I won't spend a lot of time on it, but there's new, new, process for, focused pre-sub, pre-sub, follow-up pre-sub, meaning, like, you know, rather than have to, go back, you know, there's usually a 70-day turnaround process for getting your written comments, etc, asking for this feedback, and they've created, like, a shorter, shorter way of getting, follow-up, target-up feedback, so you don't have to keep going back through that program. But I think there's also just overall, if I were going to summarize what they're doing there, and so I'll try to keep moving along.

Quickly, here's just… they're trying to, mete out that program a little bit, where they're, you know, giving options for more informal interactions. That's always been there, but they're trying to, I think, emphasize that a little bit more in this agreement, and also adding what… the big thing that's gotten a lot of agreement over on the right side of the slide is a new $2,000 fee that will come with most pre-subs. For up until all this time, this very popular program, they've been collecting no user fees for it, and I think that's, you know, this new $2,000 fee is, you know, a way maybe to get some revenue for it, but I think primarily is a way to make companies think twice about, you know, is this worthwhile to spend time on this pre-sub for this, you know, take a beat.

is this worth $2,000? Should I… or should… is there… should I spend my time with the great consultants on this call instead to work out my program, rather than asking FDA, you know, questions? I know Phil's going to get more, I think, in a little bit into pre-sub recommendations, so… so I think that that's always something to be mindful of, when the right time But the other, other, key element, you know, there's some interesting… it doesn't really do any big changes to, to review goals overall, you know, we've talked about how they're meeting their MDUFA goals, and basically, by and large, not 100%, they're sticking with those goals, and with the idea of, like, that's…

when they stick with them, and FDA's mind at least, you know, that's kind of… there's not much more they could do on efficiency. The idea is kind of to improve that, how… how… consistency. So they've added some additional meetings to the DNOVA process to make that move more smoothly. The biggest thing, and I think is the kind of most unusual element of the deal in my mind, actually, is the fee structure, in the sense that For the first time in a while, you know. And this is something that would be in that infographic we mentioned, so I'm happy to, if anybody's interested in that, the scorecard. But, you know, fees will be going down, at least in the first year, compared to…

you know, user fees will be actually going down for a lot of companies by a little bit, or… and by a lot, maybe, when you come to the annual registration fee. With a, with a small caveat, that… that's, there's a sort of a U.S. versus non-U.S. element to… to that, to that, to that dynamic. So, and we could actually even probably go to the next slide, or we don't have to, those all kind of go together, but, it's, it's, it's, basically, if you're a… user fees will go down for most companies, and If you're… for the facility fees, there's a facility fee that every, you know. facility. Companies pay for every facility. They have, like, a manufacturing production of devices. They need to register their facility with the FDA, and they pay a fee, and those fees, if you're… if that facility is based in the U.S, are actually going down by, like, you know, almost 15% or something for, in fact, FY28.

Rather than 27, but if you're… that facility is based outside the U.S, it's going to be going up. Similarly, there's, you know, for most… for… for submissions, the fees are going, slightly down in 2028 across the board, standard fees, but if you are a company that doesn't file a U.S. tax return, which, you know, complicated set of circumstances there, then you will not be able to take advantage of small business discounts Which are very, you know, steep discounts or exemptions in some cases. So, that's an interesting element that I think will be important. But to me, honestly, just taking this back here, like.

That we have hiring, the baseline there on the slide, and to me, that's the most important element, calling back to some of the things we were talking about earlier, is This is about, you know, keeping the center resourced. In the prior agreement, there was all this, there was all these goals, and here's… you're supposed to hire this many people in this year, this many people this year, and they've kind of done away with that, instead of saying, like. we're just gonna commit to hiring, and we're gonna commit to reporting out how many we're hiring, so hopefully that industry could keep a close eye on that, because I don't think that necessarily worked out the way they thought, with all the complications of

2025 and layoffs, etc. But, so, you know, we're really just… it's… this is not… this agreement, just to be clear, you know, this is an agreement. It's not the ground truth quite yet, because the, MDFA 6 Agreement, occurred, you know, a draft agreement occurred this summer. That's sent out to Congress. It has to be approved by, by the end of next September, 2027, to keep these, important resources and goals flowing, for CDRH. But, you know, there's so much we could talk about here. I did a whole session on it for Sean a while back. I'm happy to take questions, or I don't know if Phil or others have any thoughts they want to…

Jump in or throw my way.

Just gonna throw one nugget out real quick. I just think this is the first time we've seen a Medufa from MDUFA 1 to 2 to 3 to 4 to 5, now 6, that we're actually seeing user fees stabilize and for some companies, go down. It's been almost a doubling in every single renegotiation. This is the first year, hopefully it's the beginning of a plateau, where it's more about sustainability of the programs and the resources in place. Just an interesting observation over the course of the last, 20 years.

Yeah, no, absolutely, and it's interesting, and I think if you look at it, it looks like they're really just trying to keep, you know, obviously inflationary increases, etc. But the far, you know, the U.S. versus non-U.S. will be an interesting… I think that is how they're capturing some of the additional, be capturing some of the additional revenue.

Increase.

and user fees for facilities is really kind of unbalanced, and I think the user fees should be geared more towards the risk of your product. Because, like, say, many Class 1 devices, you know, GMP exempt. 510K exempt, whatever. They… they… those are… those are commodity products. And… and it's not like, because the fees went up, you can charge that much more for a tongue depressor. You know? So… so it's like, really, what… what are those comp… you know, FDA is inadvertently setting it up. to drive people out of industry, because they can't… they don't have any more margin to… to make on these commodity products, because they're having to pay, you know, I think this year is going to be $13,000 a year.

Right.

Right, and interestingly, under MDUFA 6, the first year, if you could say you're a U.S. facility, it will go down a little to, like, $12,000 a year, which is, you know, not, I'm not suggesting that's massive, but… but if you're not, it'll go up to, like, $17,000. So, it's interesting, right, they're not… it's not risk-based, which would be an interesting way of doing it, because, right, the idea is it's just geography-based, which I think aligns with some of the you know, you know, valid costs, of course, of going… having to go outside the country to investigate a facility, but also aligns with maybe the administration's policies on, you know, the America First type stuff. So yeah, no, it's an interesting…

Dynamic that's been added, though.

So before we move on to the next slide, I just want people to drop in the chat A, B, C, or D about the $2,000 pre-sub fee. We'd love to have your feedback. This is a non-official poll, but, you know, we have, We'll be tallying all this information and writing it up.

Yeah, because I do think, and just on that, so it's just a pass on to those, like, right, I really think that that fee is very much targeted at You know, making… maybe put… making people think harder about whether they need a pre-submission or not, more than… more than the revenue element, and thus that maybe sets up discussion on what, you know, what is valuable for a pre-submission here. We're talking about on this slide.

So, in June, Steve was there. Michelle Tarver gave a great speech at, the IMSC, safety conference in, in Boston. Michelle was there, and… Yeah, if you would like a copy of the article that we wrote, just write, Tara article or whatever, and we'll put it in there. Filed a pre-sub last year, typed useful, not useful, not filed. But… you know… Who wants to talk about, Pre-submissions.

I'll jump in here quick, with a couple sort of highlights here. Dr. Tara's comment on a good pre-submission, I think, is really valuable, at least from FDA's perspective. I think, in my experience, I do pre-submissions, probably averaging about once a week right now. the value, or what makes a good pre-submission is really in the eye of the beholder. And I think, to me, the biggest sort of indication of what's going to be a good meeting, or a good outcome, or a bad outcome, or one that wasn't valuable, is clarity on what are we actually trying to get out of this meeting? There's a variety of reasons a company might want, or think they want, or need a pre-sub, and there's a couple different categories, and I'll identify them quickly. One is we've got a very specific question. We're planning on launching this product in the next 18 months, 2 months, whatever the date's gonna be.

We're planning on doing test X or Test Test Y. What does CDRH think will be a more valuable test? Absolutely, that can be… that's extremely valuable information to get back from the Center. I'd argue maybe there's other ways you can get that information more quickly if it's that specific, but having a very specific ask that is going to be executed by the sponsor is critical. So if you've got a decision point, there's a fork in the road, you're deciding to go left or right, absolutely get the input from FDA before you make that decision. There's also other companies that have a very valuable strategy of, hey, we kind of know what we're gonna do, but we do think there's valuable of giving our review team a little bit of a heads up, an opportunity to ask some questions, get them ready for the submission that's coming in.

That's less valuable for the company, but it's not wrong, there's no inherent negativity associated with that product. But if… so oftentimes, companies will come to me and say, hey, we're planning a pre-sub because we think we should do a pre-sub before every 510K. If there's no ask, there's no larger value that you've articulated and identified. Why are we having this pre-sub? I've coached probably half clients that come in to me with prep for a pre-sub. I coach them out of, well, what are we trying to get out of this? Are there other ways that we can get this information, and are we better of just moving forward with a pre-market submission, or some other decision now, and waiting for that feedback to come in through another mechanism? So I think, to me, what makes a good pre-sub is, what is the purpose, what are you hoping to get out of it?

And is this the right format? Is this the right mechanism to get that appropriate feedback, is really, to me, what's determinative on the sponsor side as to whether or not it was a good submission or not. I'm not sure if anybody else… Michelle, did you have thoughts on what might make sense here?

Yeah, I think that second one about, do you agree with this, yes or no. you know, I… I don't know how much I agree with this, because I write very detailed and specific question… statements, like, I make statements, and then I ask a question about, like, along the lines of, does FDA concur that A, B, and C are the appropriate path? So it's, like, not necessarily a yes or no, but I definitely ask for concurrence, because if they don't concur, I've found that they go into a good bit of detail, especially if you get written feedback. So what do you feel about that question?

I think you're absolutely right, Michelle, and I think it's the art of how do you ask the question, whether it be informally, in an email to FDA. To me, the art comes down to how clear do you make the ask? Quite frankly, how much… what's the volume of data, or even just, quite frankly, words that you're asking them to look at. I always recommend to my clients, if there's a way we can fit this in an email, we might get the feedback you need in 24 hours, rather than waiting 70 days for a pre-sub to get scheduled. The second part of that question is the art of, how do you ask it orally? So, obviously, you've got to put into writing what your questions are, but if you're asking for that meeting face-to-face, if the answer is no, we don't agree, and I agree with you, we always frame it of.

Here's what we're planning to do. Do you… are you aligned with this proposal, yes or no? Oftentimes knowing that, hey, maybe they're aligned with 80% of it, but we want to get some additional feedback. How do you tease out that information, oftentimes orally, in that call that you're going to have? It's the yes and, it's the asking the probing question, often also framing it, who asked that question on our side? A question coming from a pure regulatory person, is different than something coming from a chief medical officer in an organization. Do you frame it as a clinical or medical question, or a regulatory

Legal interpretation question really can have an impact on how they respond and how much detail we get in that response.

If I can, dead… take a side… side road here on this conversation. I'm always very interested in the 513G and the… the response and pre-sub. So, I've had it recently when, We've asked questions, even questions that were almost word-to-word out of the pre-submission guidance document. And they came back and said, you need to do a 513G. It was almost like they were just trying to get it off their plate, and… and so it was interesting because that… the pre-sub process, obviously, it doesn't have fees right now. But the 513G does. Resubmissions have a metric associated with their review. 513Gs don't.

So, therefore, the 513G turnaround time that's supposed to be similar to the pre-sub is really creeping into 10 months I got for one that I did. And so I feel like, and this might speak a little bit to the staffing things that you guys talked about earlier, that… that… that in the pre… in the free pre-sub, but has a performance metric, that they were trying to shove things in. To a different type of submission for both the fee and to get, to get that work off their plate and get it onto another platform that's not measured and isn't going to affect their performance reviews.

Michelle, it's a great call-out, and I'll make my comments really brief here, because I think we have to move, but the metrics that we track in the MDUFA user fees and commitments drive drive process, drive, where the agencies send us different things. And I know I've negotiated 5 different user fees at this point, representing industry, trade associations, and once or twice during FDA. We try to be as careful as we can in terms of what we identify as metrics, because we know it is going to have a downstream impact in terms of where a reviewer, an office director, is going to point people. One final comment, I can't let it go without sort of saying my comment. 513Gs, there's a time and a place for them, but in my experience, that's where great questions go to die. There's very little oversight. Everything

most things, at least during my time and Steve's time at FDA, everything had so many levels of review before you got that level of predictability, so things have to be reviewed by OCC and maybe the center director's office. I do whatever I can to avoid submitting a 513G. I know there's a higher degree of reliability in terms of accountability of things that are provided in a 513G. I'd rather get 95% confidence in a response in a much more abbreviated process than wait a year and a half for a 513G response. To get that additional 5% of clarity.

Two quick questions before we move on. What does a 513 cost? I know it's a lot. And two, Phil, I want to underscore what you said about being able to get your questions answered in an email. And if you could touch on that briefly.

I don't know the cost of a 513G off… off…

Last year, I think it was around 5,800, so it's probably around… just north of 6,000 now.

Yeah, exactly.

to the second question, just like everything, there's an art to the FDA email. How do you provide… so, basically, the question comes down, and this applied to me and probably Steve when he was at the agency. Oftentimes, it's very easy for FDA, anyone in the center, to say, hey, submit a pre-sub, and we'll dig into it, and we'll provide you that answer that way. But oftentimes, what we want to do is we want to frame the request so it is easier for them to just respond. So, if it requires 3 attachments, if it requires three pages of analysis, or sort of framing the issue in the email, I just know FDA's not going to respond. The response is going to be, submit a pre-sub, we'd be happy to get back to you and have a conversation with you. But if you can distill those three pages to a single paragraph with 4 bullets that clearly articulate the issue.

And then sort of frame a single question. If it's going to take that reviewer, that manager, that office director. 14 minutes or less to respond to your email, they are inclined to respond. They don't want to go through the pre-sub. That creates burden on their side as well. But if it's going to require them to block off a half hour on their calendar 3 days from now to digest, maybe check in with 3 other people, they're disincentivized to responding back to you substantively. So it's trying to think through what's the level of detail we need to provide, how clearly can we articulate what our specific question is, and how can we make it and frame the question in a way where it is easier for them to respond with the appropriate answer than

it is for them to kick us out into the more formal pre-sub process, and that is easier summarized the way that I did just now. that articulated, particularly for your consultants, your lawyers who might not understand all the nuance. What we also want to make sure is, in that communication, you get the response back that's actually going to be helpful. If you get a response back that didn't have all the detail, all the information, that might be a really critical factor in how FDA thinks about that issue. that 15-minute email response might not be as valuable as you think it was. So, it's a very nuanced answer, but I will say regulatory question-making emails to FDA are very much more art than science, but it really comes down.

Creative writing, for sure.

Very much, Michelle.

And similarly, responding to 483s, there's an art to that. That could be an entire session unto itself. We want to make up for a little lost time. I think the 483 section is a good place to do it. So let's ask the audience, do you have an open 483 from before? February 2nd, which standard are you remediating to? Type ISO 820, or not sure? And on that note, who's gonna take the… this 483 section? I do not remember.

I can get started. So… it… it… the FDA, I mentioned this earlier, in warning letters that were issued after February 2nd, 2026, they specifically said, that… that we want your… your reactions, your responses to be compliant with QMSR, and that you need to implement QMSR into the changes that you're making to your processes to… to even be compliant with what used to be QSR. So they're really behind the eight ball, because now they've got to meet the expectations of QSR, under which they got their warning letter. And then add in not only fixing those things, but adding in, bringing it up to date with the QMSR.

You know, how I would attack this, and I wouldn't do this for just 483s or warning letter items. I would do it for anything in that Kappa process, probably a lot of things in that complaint process. But… but pull all of those open things and check if they're… how… what your references are there in terms of being to 820 or ISO, and map each of those open events to the… the clauses under ISO that are pertinent to what the… the… The item, the inspection item, was about. So that's kind of how I would move about a remediation activity, where we got… where you were in trouble before February 26th versus in trouble after. Then you can at least map where you've ended up, and then move forward.

Yeah, I think that the points that Michelle, makes are good ones, and I think that there's a higher level point that touches on some of what Phil was discussing, and it's at least worth articulating, which is It is really the onus on regulatory professionals within companies to develop positions that they believe are defensible, and to be ready to articulate them before FDA. So, whether we're talking about a pre-market submission or hear how a 483 was handled. It is essential for companies to be prepared if they are engaging with FDA to lay out what their position is and why they believe that that position aligns

with current regulatory requirements. It is not the case that those regulatory professionals have to be correct in all circumstances. Certainly, there may be disagreement in the 483 context about what the company believes it must do versus what FDA believes it must do. But the likelihood of a good outcome for the company is orders of magnitude greater if the company has a rational and well-articulated regulatory position, rather than simply waiting for FDA to come in and tell them what they did was right or wrong. And I think that the same point applies To the pre-sub context, which is that it is the onus on companies

to walk in and articulate what they believe is the path forward, rather than relying on FDA, either explicitly or implicitly, to answer those questions for them.

Thank you, Steve. We have a number of questions from the audience. I'm afraid we're not going to get to all the questions from the audience today, but we will follow up with you. One question that I have, is, about AI in the review process, and, it's… it's come in in a number of formats, so I figure I'm gonna just sort of, you know, what it… What are they doing with AI in the review process?

So, I'll kind of jump in here. I had somebody that called me and hired me to help them. It was a U.S. agent for several companies in China that all made gloves. Now, these were all separate companies, all separate clients of his, and… but… All four of them got a letter from the FDA that said the FDA was going to resend their 510K because of some data that statistically looked too similar to somebody else's data. And so… but the thing is, is that those 510Ks were from the late 80s and early 90s. It's like, how did they even know that? Well, the FDA has you know, turned everything into digital format, and now I can use this AI to compare test methods and technical data and whatnot. So it turned out all four of those used not only the same lab in China.

But then they also use the same consultant to put their 510Ks together. And so it turned up a mismatch of, you know, that basically looked like they had falsified their data, because across 4 disparate companies. the result of the data were almost identical, and the FDA was like, we can't do this. So that's just one example of how they've been using AI to even get in the time machine and kind of go backwards and You know, worse than… worse than stuff that has been on the market since the 90s.

So, let's keep moving. We have 9 slides and… 18 minutes, so that's 2 minutes a slide, but, Jeff, Angelina had to step out, so I'm gonna let you take this, and let's talk about, you know, what's going on.

Sure, I've worked for large medical device companies, but the predominant majority of my work inside companies as employees has been in small companies. And one of the things that you have to realize is that, one, they're constrained by funds. Which means that submissions are something that are difficult to do. Putting in a quality management system that meets all of the requirements is something that's fairly difficult to do. And having staff who can keep all of that up to date is… is something that costs, and Some of the things that I have heard from top management, and these are in discussions aside from

you know, company meetings, it's like, well, you guys are the Department of Sales Prevention, you know, so they're not looking to have these people on staff that are going to help them to meet some of these types of requirements. So the QMS are for small medical device companies that have Class 1 medical devices alone. You know, some of them are a mix of either, devices that, you know, don't require certain types of documentation. These are the exempted devices. They really are on the very low end of the risk spectrum, according to FDA's list of how they're going to be inspecting companies. So, to them, they're waiting to see what FDA is going to say once they come in the door. It's a risk

based value of how much work do we put into it now? So they'll say. We're just gonna wait. We'll see what they say when they get here, because our device hasn't changed. We've been making that same device, you know, for the last 20 years. So, we haven't really had a need to make any changes organizationally. And this was 3 companies I spoke with recently. Two of them had not done anything with QMSR. they were not ISO certified or MDSAP certified either. So these are the ones that are typically waiting until something happens Before… and that's going to be a for-cause inspection, or something along those lines where FDA's going to go there. It's not likely they'll ever be inspected by FDA. And to them, that was the best way of approaching it. Again, same product, same manufacturing process, nothing changed.

Now, these quality management system, applications that they have to put into place are what are costs. Hiring somebody, getting certified, any of those things, they detract from… or they have to detract from the bottom line. That's the way they're looking at it, from a financial perspective. they didn't really understand what the changes were, besides the M, after QSR, or in between QSR. So to them, it really wasn't anything that was big and required a lot of work. When, you know, we had a discussion, they go, oh… Well, that's really not that big of a change. So we could maybe just go through and do a search and destroy in our quality manual, and put QMSR instead of QSR. You know, they look at it very simplistically.

And they don't want to put the resources into play until there's a requirement for it. You know, when someone comes and says, you need to do this. And that would be an FDA inspection, or it would be, in some instances, a supplier coming in, doing an audit, and saying, you've got to get this completed. And then, on… risk. When I explain to them, as Michelle described, you have to be able to integrate risk throughout the company. What you call it in each of these different areas, and how you measure risk is a little bit different when you say, well, we already do that. The risk… it's like risk and reward for buying a product or a machine. You're looking at what that ROI is going to be. So they look at it very differently than large medical device companies. And large medical device companies have those resources to be able to apply.

The small ones don't. So, to them, the document didn't really change much. The inspection technique did, but, you know, ultimately, they're gonna wait till that happens. Yep.

They would rather take the hit and do remediation. Afterwards, then do it right from the start. And, you know, one of the reasons why I named my business Lean is because regulations were getting so complex, and I really specialize in finding, like, okay, what activities do you do? And how do you do them? And let's write something around what you're already doing so that you don't have to change, but you understand how it… where it fits in the regulatory structure. And so lean is, like, you don't get more than you need before you need it, but now, like, the FDA's really gone so far, like, it's really hard to apply some of my lean principles of how I was building procedures before.

Because it's… it's become very… the few… the handful of audits I've been involved in was very much more of a checkbox, where if you didn't have… you need… you needed quality management, and it specifically needed to say this. Yes. Or, no, you have a finding.

And one of the things small medical device companies do, they don't hire people to work within their company, they hire people like me and Michelle, and they have people who have experience in the industry to help them come set something up. And to them, that's a better cost than applying We're, you know, hiring a quality manager or a regulatory manager to help with that in the companies.

So I'm going to skip over this slide because we've covered it to a large extent. And moved to, the new programs.

I think that one's me. So, there are, several new programs that you need to be aware, of, that FDA has in play, and one of them is the ASTA, which is the Accreditation Scheme for Conformity Assessment. And what… the problem I see here is that companies just go, because there is a list on the FDA website about which labs are accredited, and they just pick one of those. Well, the accreditation is in two parts. One is for your overall quality management system. and your processes, so that they know that you've got the processes in place to properly execute whatever tests you're ordered. But then, you also have to have a qualification

per test, per item. So you've got to look for both of those when you look for the ASCA, that they're on the list, and then what are they on the list for, and is that what you're hiring them to do? Fda has also done a lot in recognizing the, the most recent, ISO standard for 10993 for biocompatibility. There's a lot going on there out there. Make sure before you do any kind of biocompatibility testing that you've gotten yourself up to date. on that new revision and FDA's position on it. And, this one, you know, I think everybody's… would be super excited about, but I don't feel like many… that people are underutilizing it, and that's the rapid, where it's a pairing with CMS and FDA, and that came out about April this year.

So, has anybody tried to do the rapid?

So I think we're a little bit early. Go ahead, David. You go.

Oh, I was gonna say, yeah, Rapid is still, I don't have to let Phila jump in, but it's still in a draft form. I know… you know, they're kind of the latest attempt to create some sort of pathway of alignment between FDA and CMS, and I know that… I think there actually are some companies that, there's a very handful of sort of unofficial piloting it, is my understanding, with FDA right now, very, unofficially, but, it's… I think it's really a wait and see. There's a lot of question marks With that program, with regards to, resources and, whether, you know, how well CMS can, you know, what types of data will be requested at that early pivotal trial stage for companies. But that can go on for… there's a lot of questions related to that, that program, I would say.

on what David said, I think. We're a little early. I think there are a handful of companies that are trying to get in there for early access. Not early access in a bad way, but sort of proof of concept, can this process work? This is… Rapid is FDA and CMS's latest effort to try to close that gap between FDA clearance and approval and reimbursement. I applaud the effort, I applaud the acknowledgement of the gap that exists there, but I think the prior attempts, we've never really closed that gap, and that's why we keep coming up with new and innovative approaches of doing it. To me, the biggest challenge with Rapid, and maybe sort of… this is coming on the heels of TSET that's now closing down.

Every time we come up with a new program, they create new inclusion and exclusion criteria. One of the issues we're dealing with right now is companies that are sufficiently far along in their clinical development stages and clinical data collection processes that Rapid might not be the best fit for them right now, and it creates this hole of, hey, CMS and FDA would love to partner on this, but you're too far along. in the process to be available for Rapid six months from now when it might be relevant. So, are there ways to have those conversations less formally? And I see a number of clients and companies trying to figure out, right, this identified goal that FDA and CMS has, Rapid's not available just yet. Are there ways to become… to make yourself available and to leverage

It's the intent of that program, which is more of collaboration and greater discussions between the agencies.

I want to move into the generative AI section. Sorry to cut you off, I didn't, but I, yeah. And so I'm going to move backwards, I think. to, you know, FDA is drafting the Gen AI rules in the open, and asked us to correct it. So, we're in a comment period. Has anyone submitted comments? Please, please drop in the chat comments, you know, or something like that. Submitted comments, if, if you have. Love to know. I think that, this is an excellent opportunity for companies to submit their comments. Who is talking about this? I can't remember. Sorry.

Boom.

I'll jump in.

Go, David, if you are, or Phil, if you're about to jump in, please do.

I think generative AI and FDA, there's so much going on. not just at FDA, I mean, just the news over the course of the last two weeks with what's happening, not just in MedTech AI, FDA AI, but AI more broadly. My big takeaway here, so we had a white paper published about a little over a month ago from FDA, a lot of details in there. We don't have enough time to get into all those Levels, of concern and topic and where the agency might be going. My big takeaway, and this has sort of evolved over the last two weeks with some of the AI companies and leadership coming out with some of their concerns about where the technology is going more broadly, and even a call for regulation of their own industry.

to me, one of the areas where FDA is… I'm sorry, where AI is most actively regulated today is in the healthcare, medical device, sort of space. So, big picture, if the government is looking at greater over… potentially looking at greater oversight. over generative AI and AI more broadly, they might take a closer look at what's happening in FDA and how they're applying it, how they're regulating it, how they think about some of the risks associated with it right now. So my prediction over the course of the next couple months. is that AI in healthcare, AI as a device, SAMD, all those areas, might be getting a little bit more… scrutiny might not be the best word, but more eyeballs on it of people trying to understand

What are the pros and cons of a higher and lower regulatory bar with regulatory oversight over here? What are things that either get in the way or don't get in the way of innovation in this space? I think the goal here is to move quickly, but move quickly without breaking things, and I think that's what the companies, the government might be looking at in the near future. MedTech AI is a good place to start.

That's excellent. Thank you.

One quick point that I'll add is companies should be considering what's the vehicle by which they are approaching FDA. So, for companies that are active members in trade associations, for example. Those trade associations are appropriately the voice of companies, and they provide a forum in which multiple companies can get together and talk through these very complex issues, develop positions that make sense for our industry and for FDA, and then present unified positions to FDA. For companies that may not be participating in trade associations, it does not prevent them from acting individually, if they believe that they should.

Or, they can collaborate with other companies in the same space, to develop interest group positions that serve the unified positions that are often presented by trade associations.

Thank you. I don't know if you're able to see the poll results, but 6% yes in the market, 4% yes in live submission, 23% on the roadmap, 50%… 56% no, and, 11% my clients do. So, I'm gonna stop sharing that. Bang… And we only have a few minutes left, so…

I want to just say here why part of this is important. I… a company, it was on the drug side, got a warning letter because they used it to implement their, GMPs. And, and it was wrong. They… but they didn't know it, because they didn't know what the GMPs are, so they just blindly trusted it, and the AI was running their show. And it was totaling total… nonsense. And they were just going along with it, so…

And Michelle, I think the one takeaway there is using… leveraging AI in your implementation of these things is not necessarily a bad thing, and many companies, and most companies right now, are starting to do so. But that doesn't mean you can hand over control. It doesn't mean that the excuse of, well, I didn't know about that, I was… I had given over control to some other program. is never going to cut it. So at the end of the day, the sponsor of the company is ultimately responsible, so it's how do you use AI in these instances responsibly in that scenario?

Michelle, I had the same thing happen with a company that asked me. They said, would you look over the quality management system that AI did for us? And I just kind of looked at it and laughed, and I said, well, you're gonna have to basically start over again. Unfortunately, what they did, you know, AI does is it takes the major points and lays them out, but it doesn't put any of the company-specific details into it, so it was easy to be able to identify.

So, we're gonna wind down. This has been a special 90-minute session. I want to thank everybody who hung in there for, the entire 90 minutes, and I want to thank our speakers today, Angelina, Steve, Michelle, Jeff, David, Phillip. For, sharing your knowledge and expertise with us. I would like to point out to the audience, that's probably about a $2,500 value right there, if you add up all their, consultant fees. And, so, You know, I just like to underscore that. And I'd like to thank, the more than 200 people who actually showed up today. Of the 527 that were registered. That's… that's a fantastic turnout rate. Look forward to writing this up.

And trying to, summarize the value for everybody. And if you have any questions or comments, please feel free to, contact me, and I would like to allow the speakers to say goodbye to everybody.

Thank you very much.

Oh, thanks for organizing, it was a great session.

Yep. We appreciate the time that you spent with us today.

Absolutely. Thank you.

I agree with my colleagues.

Thank you. Thank you all for your time, and we look forward to seeing you again very soon.