FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates.

They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes.

Interested in sponsoring an episode? Click here to learn more!

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key timestamps

• [00:00] - Introduction to the episode and guests
• [02:15] - Overview of Greenlight Guru's QMS software
• [04:30] - Introduction to the FDA's proposed rule on wound dressings
• [06:00] - Mark DuVal discusses the broad implications of the proposed rule
• [12:45] - Kathy Herzog explains the performance requirements and administrative record
• [22:00] - Discussion on industry response and potential litigation
• [30:30] - Impacts on existing and new products in the market
• [40:20] - Strategies for companies to navigate the proposed changes
• [50:00] - Broader implications for the FDA and potential future regulations
• [60:00] - Final thoughts and ways to stay informed

Top takeaways from this episode

1. The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.
2. There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.
3. The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures.

Practical tips for MedTech professionals

1. Stay informed about regulatory changes and participate in comment periods to voice concerns.
2. Prepare for potential new testing and data requirements by reviewing current performance testing protocols.
3. Engage with industry groups and legal experts to understand the full impact of proposed regulations.

MedTech 101

• Classification of Medical Devices: Medical devices are classified into three categories based on their risk level: Class I (low risk), Class II (moderate risk), and Class III (high risk). The FDA's proposed rule aims to classify certain wound dressings, potentially impacting their regulatory requirements.

• 510(k) Clearance: A premarket submission to the FDA demonstrating that the device to be marketed is at least as safe and effective, substantially equivalent, to a legally marketed device.

Related links

• Greenlight Guru QMS Software
• FDA Proposed Ruling on Wound Dressings
• DuVal & Associates Client Alert on FDA Proposed Rule
• Alliance of Wound Care Stakeholders
• Washington Legal Foundation
• Connect with Etienne Nichols on LinkedIn 

Memorable quotes from this episode

• "This proposed rule feels like a solution in search of a problem." - Mark DuVal
• "It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog
• "FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuVal

Audience feedback

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Transcript

Etienne Nichols: Welcome to the global medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Hey guys, real quick, I'd like to tell you about Greenlight Guru's all in one QMS software. It's designed specifically for the medical device industry, and Greenlight Guru ensures compliance, accelerates innovation, and simplifies the entire product lifecycle.

So, Sega byte of spreadsheets and manual processes and embrace efficiency, reduce risk and bring your devices to market faster with confidence. Join the leaders in MedTech who trust Greenlight Guru, elevate your quality, boost your productivity, and make a difference in patient lives.

Greenlight Guru, where innovation meets compliance to check it out, go to www.Greenlight.Guru hey everyone. Welcome back to the Global Medical Device podcast. My name is Etienne Nichols.

I'm the host for today's episode. With me today is Mark Duvall, president and CEO of Duval and associates, and Kathy Herzog, who is the senior regulatory, quality and compliance associate at Duval and Associates.

How are you all doing today?

Mark DuVal: Good, Etienne, thanks for having us.

Etienne Nichols: Great to have you. Well, the reason I wanted to talk to you all today was the FDA, I believe it was, back in November, they had a proposed rule for wound dressing titled Medical Devices general and plastic Surgery devices.

Classification of certain solid wound dressings, wound dressings formulated as gel creams or ointment, and liquid wound washes is kind of a lengthy title for this proposed rule. But I wanted to bring you all on today just to talk about what this, what this rule is, so we can help the audience understand what is going on in this proposed rule.

Wonder if you could start, Mark?

Mark DuVal: Yeah. And Kathy, don't hesitate to chime in. Kathy's, she's steeped in this as well, and she was part of filing our proposed comments that we filed anonymously on behalf of some clients.

But the idea is a very broad one, and that is to use antimicrobial resistance and its effect on the microbiota as a resonator for proposing a rule that is a very all-encompassing role on wound products and wound gels.

And this is a really well characterized, well known and quiet area, frankly. And Kathy's an expert. She, as one of our biomedical engineers, she spends a ton of time with the agency on this, making submissions and making arguments why we should expedite clearance for these products.

But they're trying essentially to accomplish two things. One is having a, a reason. I would call it a pretext, AMR as a pretext or antimicrobial resistance as a pretext for regulating this category of products.

And what if. And so, two things are supposed to obtain. One is that for new products, they would have, there would be a new list of performance requirements. And I love Kathy to delve into that because she knows I'm cold and it looks like it's there.

It's an attempt to expand what they aren't. You know, usually when we get in and they ask for some of the things they're asking for here, we would challenge them and usually successfully and get them to not ask for what they want for the clearance of these devices but ask what they need. And at least burdensome parlance, we would call that the minimum necessary amount of information.

The second thing is for existing products, basically, they want to start taking out, taking away some marketing claims, intended use claims that are already within the legal order. That is what a 510 is. So, they really legally can't take away those claims, but the regulation purports to do that.

So that if you want to retain some of the claims you currently have, you'd have to go back to the FDA with additional data. And so, it's pretty frustrating to us because, and I love for Kathy to talk not only about the performance requirements, but the administrative record, we believe is really thin, because when you propose a rule, there's got to be a reason behind it.

Right? As we discussed, and the FDA is hearkening back to a 2016, what was it? It was a panel meeting. I'm sorry, it slipped my mind as a panel meeting that we attended, and we spoke at, where they came up with a reason, and they were voted, FDA was voted down at that point by 14 to two, vote to not change or reclassify these products. And here we are a few years later with the same commissioner who was then the acting commissioner revolving back in as the actual commissioner, and he continues with his onward march to try and get this class of products wound dressings reclassified. Don't entirely know the rationale for it. Sometimes they think it's just to generate a bunch of new studies for a lot of academic institutions and the FDA to review.

There hasn't been a lot of additional data between that intervening panel meeting in 2016 and the current time that would substantiate or undergird their request for reclassification. Cathy, do you want to elaborate on some of that? Because I know you're really familiar with the administrative record or lack thereof.

Kathy Herzog: Yeah, I mean, simply put, this is a class of dressings that has been on the market successfully and safely for four decades.

And what FDA has been attempting to do over time is classify these unclassified pre amendment wound dressings. But when you have 40 years of experience, that should be paramount in terms of determining what level of classification and if special controls are needed. And as Mark mentioned, the backbone or the primary genesis of this proposed rule is a belief, and in our opinion, that's an unsubstantiated belief, that these types of wound dressings that contain antimicrobials, and that's an important characterization of these products, they contain antimicrobials. And FDA is suggesting that the presence of these antimicrobials contribute to antimicrobial risk.

So, it's known that preservatives can have mechanisms of actions by which they produce or could produce antimicrobial resistance. But it's not a definitive clinical observation. There isn't a smoking gun here that says definitively this is a risk that would justify the proposed special controls related to AMR risk and effect of these wound dressings on the periwound microbiota.

So, these are a couple of the special controls that FDA is suggesting that are mostly problematic in the proposed rule and are confusing to industry how they would actually conduct performance testing to assure that these devices remain safe.

Etienne Nichols: And I know. Yeah, go ahead.

Mark DuVal: No, I. Can you go first?

Etienne Nichols: Well, what I was going to say is I know this is still in a proposed state, and so the period of comments has passed by now. And I was actually looking at your client alert, which we'll put a link to in the show notes so that people can, can read that 56 people objected or 56 of the comments.

Of the 74 comments were objections, only two agreed with, with this. I'm really curious what the impact will be and maybe, maybe before we get to the impact, but do you anticipate some of the ruling changed?

I don't know if you have any insight into how the final may differ from the proposed. If you have any thoughts, there.

Mark DuVal: Yeah, we've got some really good connections within the agency on Capitol Hill and with the trade associations, and we happen to have some insight information. We know that.

And this transcends just the wound dressing regulation. FDA is trying to rush through a whole bunch of things right now on laboratory developed tests and this proposed rule and a whole bunch of other things that look rather precipitous.

And we know that they're trying to get through before the election. We've been told that by a number of people and so we know that they're concerned about a change in administrations, whether that happens or not, that they might not have as favorable an environment for what they want to do.

So that's one thing.

And there are a lot of companies and there are a lot of trade associations that have gathered together that are trying to stop this proposed rule. It really, to them and to us, feels like a solution in search of a problem.

The sky is not falling. We recognize and appreciate that FDA has a bona fide concern for AMR and its collateral effect on their microbiota. But there's no objective or circumstantial evidence to support such a belief as it relates to wound products.

And the additional testing proposed by the FDA, in our view, is not relevant, frankly, to the theoretical threat that antimicrobial wound products pose on AMR and the effect on the microbiota as a public health issue.

In fact, they never called for taking any products off the market. If this is a true-life scare, they should propose something like that. But they're not, because they'd be, that'd be crazy, because wound products actually prevent the antimicrobial issue from getting larger than they are, where they're not direct.

They're not really addressing a lot of the products that are casually on the marketplace, like hand washes and solutions and things that you might see in schools and in, you know, large employers. And we see them here in the skyway in downtown Minneapolis, so you can pump stuff in your hand. There’re all sorts of places where these products exist, and those aren't even being addressed.

Those are more, far more ubiquitous and used.

You know, you tell a physician they're taking, you're taking away an antimicrobial wound dressing from them, and they'd say, that's malpractice. I can't, you, you can't do that. You might have surgical site infections.

We might have all sorts of problems that could result in amputations. It could result in, you know, some serious infections in sepsis. So, they're, you know, there's a far different view of this from the medical community than there is FDA. And again, that's why you probably thought that was rather provocative. And then I said, what they're trying to do is a pretext, but that's why we say that there's really no medical record. If I might quote, if you permit me, this is from the proposed rule.

There's an adjunct to the proposed rule where FDA always has to find, do a preliminary regulatory impact analysis, and it's called an initial regulatory flexibility analysis.

And this is from page ten of that second regulatory document. And let me just read this.

It's really a funny application of an economic theory called negative externalities, which is supposedly supposed to substantiate the, the reason for this rule. So, it says this, the proposed rule addresses a source of market failure associated with the use of these products.

The use of a wound dressing or liquid wound wash covered by this proposed rule potentially imposes a cost on society in the form of increased prevalence of AMR. Now, follow the follow this logic.

I almost had an economics minor when I came out of college, and I was one credit short of it. But I know what negative externality there, and this is pretty funny.

It goes on to say, because medical providers and their patients primarily focus on the private benefits and costs associated with the use of a wound dressing or wash, they fail to fully account for the contribution of their use of these products to AMR prevalence.

In society, this is known as a negative externality. That's in economic terms; it goes on to say a consequence of a negative externality is that the wound dressings or liquid wound washes may be used too frequently.

Given that the private benefits and costs of their use do not incorporate the additional social costs of AMR, federal regulatory actions such as this proposed rule may help alleviate, it says may help alleviate, doesn't say will help, this market failure by limiting or changing the use of wound dressings and liquid wound washes containing antimicrobials.

That is as ridiculous of a rationale as I have ever seen.

And it's. Well, I don't know. I love Kathy.

Kathy Herzog: Well, I go back to an opening comment.

It's rare that you would have 40 years of history on a particular wound dressing class here.

The 2016 panel that mark referenced, FDA had done an analysis of MDR. So MDRs are medical advice reports where a manufacturer or an end user can report alleged complaints where patient serious injury or death may have occurred.

And so, if you take a look at the amount of time these wound dressings have been on the market and the millions and millions of uses, there's a lot of exposure here.

And at the 2016 panel, FDA had a slide presentation where they summarized that over 22 years that they looked back, there were 1125 MDRs, but there were no deaths attributed to the dressings.

There's no obvious link to AMR, and the most common reported problems are erythema, which is redness, infection, and blisters. But none of those would rise to the level of. We need to really change our whole mindset on how this class of dressings is regulated.

Etienne Nichols: That's a really good point, and I'm glad you brought that up. I love hearing the history about it. And I think, I don't know if the pandemic and the prevalent use of, like you said, what's out there in the public now has changed some of the thoughts. Regardless of that, I'm really curious what your impact analysis or what your thought is on x number of companies, x number of products that could be impacted if this rule is finalized as is.

Mark DuVal: Oh boy.

Etienne Nichols: Do you have any thoughts?

Mark DuVal: What do you think, Kathy?

Kathy Herzog: My worry is that there's such a vagueness in the special controls that are proposed. For example, performance testing to characterize the AMR risk. AMR risk assessment, performance testing for periwound microbiota influence testing on delayed wound healing potential.

It's so difficult in the context of how ubiquitous antimicrobials are present in the general world that to conduct a study on the backs of a singular manufacturing wound dressing for a global concern is not fair to the industry.

It's too much to absorb. These should be government led studies to tease out if these localized dressings are really contributing to AM. So, it's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing.

Etienne Nichols: Well, I was just, I was just curious what the broader industry response has been to these proposed changes or if they're aware. I mean, it sounds like it's going to be pretty heavy.

Mark DuVal: If, so, if, if the effect, let's talk about first existing products. If the effect is to deprive or take away claims that they currently have, there'll be litigation there. The FDA is not allowed to use a regulatory framework like this to override a congressional statute that has created the 510 is a legal order, as I mentioned earlier.

And you can't just say, okay, now we're going to tell you that you can no longer have the claims you've been legally granted under a statute by virtue of a subsidiary regulation that FDA has kind of created as a figment of its own regulatory imagination.

So, they cannot do what they're doing. And I think, you know, there may be a class action where they, a lot of companies will sue the agency so that they're not deprived of the current labeling that they have.

The second one is with respect to new products who are going to reach back and look at the predicates as they always do, and they're entitled to rely under the statute as current legal orders that are already on the market, and there are hundreds, if not thousands of them.

Right. They're going to be able to cite something as a predicate and FDA is going to say, no, you can't use it anymore, at least not with these claims. These are the new set of claims you're going to get, and these are the new performance tests you're going to have to conduct.

And are those commensurate, those tests really commensurate with what the concerns are? And the concerns that they raise have to be substantiated concerns, not just theoretical concerns as they are today?

Look, I'll give you an example. A long time ago, I went with an orthopedic company that was trying to coat antibiotics on its orthopedic devices. And the FDA at that time said, this is back when Christy Foreman was still director of the acid device evaluation.

That tells you how long it goes back. And I remember she said, well, you guys need to do testing for antimicrobial resistance. And I'm like, whoa, whoa, timeout. Wait a minute.

You're telling this small orthopedic company that they're going to have to do a study of societal magnitude that you haven't even asked the manufacturers of the antibiotics to conduct to demonstrate antimicrobial resistance?

And furthermore, what orthopedic surgeon is going to put those kinds of devices in a human body without slathering it with an antimicrobial or antibiotic? Because that's just malpractice.

And I knew they were being pressured by Cedar. A lot of this, I think, has its genesis from Cedar thinking, because these are all combination products and they're putting the weight of their authority behind it.

But CDRH is left to administer it. And I kind of feel sorry for them, frankly, because it's a problem that's looming. It's a problem that's on, like we called it, a runaway train.

That's what we seem to have here. And so, I close, maybe, and I know, not closing the whole broadcast, but close with this. Part of the thought is, I've postulated this question.

Why is it that FDA often feels the need to overregulate quiet, well known, well settled product categories? Is it fiefdom building? Like I said earlier, is it a scientific expedition without a destination? Is it a mindless escalation of data requirements?

Is it regulatory boredom because the 500 and K program, who likes a quiet, well managed by category? Or is it all of the above? And I don't know what it is, but why do we get these things from time to time.

I think Commissioner Califf needs to do some explaining to industry about why is it that we're suffering through this, all of this in a quiet, well established product category.

Etienne Nichols: Well, and you mentioned the potential for pretext, and you believe this is a pretext and already stated about some of the people that some of the insiders who believe this is something they're trying to get done before the administration could potentially change.

If this, if that does get through or if it doesn't, I'm curious, like two different paths seem to be before us then, and I don't necessarily want you to ask you to speculate, but how do you see this changing from a bigger picture from the FDA?

If the administration does change, if it doesn't change, do you have any thoughts on the potential from a bigger picture view with the FDA?

Mark DuVal: I'm going to start and then let Kathy contribute because she did a lot of individual submissions. In fact, she's confronted with two products already where they seem to be carrying through some of the thinking in the regulation to individual product submissions.

But I think broadly, the agency, if I'm concerned about the precedent being set, if the agency can use regulations to essentially go outside the scope of the statute that would allow them to create a subsidiary regulation, that's a bad precedent. This is well beyond their jurisdiction and authority in the arena of wound dressing products. And they're very cavalier about saying that they have authority. They're very cavalier about laboratory developed tests.

The agency is getting quite strident in a number of product and regulatory categories that in my profession, in the legal regulatory profession, we're becoming concerned with how bold and embracing they've become. So that's my overarching comment as it transcends the wound dressing products.

Kathy, take us down into the granularity of submissions and what that could look like and maybe what you're even starting to see with some current submissions before the reg has even been finalized.

You're on mute, Kathy, thank you.

Kathy Herzog: I got allergies, and I'm trying to spare you from my throat clearing.

I think an area that has been confusing is you have these wound dressings that contain an antimicrobial as a product preservative, and they're treated as active drugs, as combination devices. And that is like a handcuff because it's an over regulation of use of an ingredient that is for product protection. It's not to have a clinical effect for wound management.

So, I think that that has caused a lot of confusion where on the drug side, these same ingredients could be represented in like a human OTC drug, as an inactive ingredient. But somehow on the CDRH side, in use in a fro dressing, for example, they're viewed as an active ingredient.

And so, I think that there are few wound dressings that do contain drugs, actual drugs that are recognized on the cedar side, like bathtracin, where an AMR risk is probably likely. But to take the 99% that contain antimicrobials at the level of a product preservative, seems like such overkill and overregulation.

And that's causing, I think, issues with moving products forward, because it's like FDA saying, if you don't have an antimicrobial that we currently have cleared, you're going to have to consider de novo or PMA to introduce those new drug components into a fro.

Mark DuVal: And what's worse, that's overkill. Yeah, it is overkill. And what's worse, I would mention, Kathy, and one of the things that we've seen is that the preservative that was maybe not present in the fro category, that they like to.

As if that's the substitute for the 510K program, because they've not seen it in the fro product code, they say, well, they've frozen the category, and you can't use any other preservatives going forward. Even if those preservatives have been safely used in other arenas on the mucosal membranes. Think of vaginal and performance testing can.

Kathy Herzog: Be done to assure that they are safe and effective. And it's the same performance test that other preservatives would be subject to worry about innovation becoming stifled, that we're just gonna, we're going to.

We're kind of like. And I also worry if, you know, when you look at the AMR risk FDA in the proposed rule, has categorized into low, moderate and high, you know, medically important antimicrobials. But in the low category, you know, that might actually influence industries to say, well, I'm just going to choose a low AMR product because it'll be easier to get it clear.

But in a way that's kind of forcing industry into a certain bucket or a certain selection of preservatives, which is anti-innovation over time.

Mark DuVal: And that's not to say, Etienne, that we don't think FDA has a legitimate concern with some of the anti-biotics and some of the more serious products that are being incorporated into a wound dressing that would require a PMA. We're not disputing that there is a category product that does require a higher level of scrutiny, no question. But to use it in a broad sweep is really problematic.

Etienne Nichols: Well, that leads me to the next question that I would have, and that is, if this goes through the way it is, what strategies do you think companies should be adopting moving forward to navigate this potential regulatory change?

Any thoughts or have you explored that yet?

Mark DuVal: Well, right now we spent our efforts trying to stop the agency getting more reasonable in their thought process, and we will continue to do that. And we know that there are groups that are queuing up to sue them.

Etienne Nichols: And I'll just say for my part that I am glad that there are people like you all out there who are concerned enough to write these comments and make these oppositions.

So, I'll just throw that out.

Mark DuVal: Thank you. We, you know, we alerted our clients to it right away and we didn't know that they started getting really alarmed as they read, read the rule. But beyond that, people, a lot of folks are going to Congress, whether Congress in a busy election year, I'm already making the prediction. Some, somebody has asked me in the past one year, was this going to be a year from now or we really have to worry about.

I said, no, it'll happen in August, is my guess, because they'll do it when August recess from Congress and they'll try and hit when they're gone. And by the time the rule gets finalized in the fall, everybody will be busy, swept up with the election.

And it'll be of no consequence to anybody at that point because it's a small item on the list of a much larger national agenda. So, they are trying to get the attention to Congress, the congresspeople right now. We'll see if that, that works. I'm just a little taken aback by FDA's just bordering on arrogance and imperialism.

They've moved from being just an administrative body to almost a quasi-legislative body. And that is a very concerning development. And a lot of regulatory lawyers in my field are talking about this at conferences amongst one another, and we're raising it in for like this.

So, we're sounding some alarm bells. The agency's taking a lot of liberties with us. When it gets frustrated with what? Congress not giving it what it wants, it moves on its own.

It's like a president signing a presidential order that's completely illegal, but they do it by virtue of the power of their position and not by the persuasiveness of their idea or following the process they're supposed to follow.

Right.

Etienne Nichols: Well, if I were to change that question then slightly because I'm sure people listening, they want to be at least I feel more empowered when I have some thought on how I can move forward with this information that I've been given. If we're not to the point where it makes sense to advise a company on how to move forward.

Assuming this is finalized, what about some advice on what they can be doing when they hear about this, particularly when it comes to FDA things I know there are things like read the proposed rule, make those comments and make those suggestions.

Are there other avenues that you think people can or companies can be involved to make positive change?

Mark DuVal: Well, if they're prepared to roll over or think it's inevitable and that a lawsuit is just going to be too time consuming and difficult, it can either continue to market in the face of FDA's opposition and raise.

If FDA actually has the temerity, which they may not have, let's say they continue to make the claims, for example, they've always been making lawfully, and wait to see if FDA challenges them by virtue of a warning letter or even taking them to court, then they can defend themselves and they have a pretty darn good solid defense.

I think FDA will be afraid to do that because the first loss case will undo the entire or at least that portion of the regulation. So, that’s one thing they could do or they could decide, look, were just going to do some additional studies and actually get those claims because that might be profitable and useful legs in the marketplace anyway.

So, there’s some business decisions to be made. Do we defend the status quo, or we decide that well move things on? I’m sure FD is hoping that everybody kind of go along to get along and, and the strength will be in the numbers of the industry as everybody starts to follow it individually, it could break apart the alliance. So, who knows what the future portends.

Etienne Nichols: Preston Cathy, I should have asked you this earlier, but I wanted to ask if you have a specific example, and you gave one about what this could potentially look like in reality in the trenches in a regulatory submission.

But do you have a, could you give me an example of this is how it's done prior to this proposed ruling, and if we were to do this afterwards, it would have this additional work. We've talked a little bit about the clinical data and so on, but, but can you kind of give an example or paint a picture there?

Kathy Herzog: Yeah, I mean, so submissions after the rule is finalized, those devices would be subject to the special controls that are defined in the rule. There's a set of special controls for class two. About class three, I think most of the products would still be in class two, so they'd be low to moderate AMR risk.

But it is going to require new research and new information in the submissions than we provided before. So, for example, an AMR risk assessment, what does that look like? How would you document it? Is it literature based? What can you pull from prior clinical studies evaluating impact of the antimicrobial on wound healing? Is there any suggestion of delayed wound healing?

I think it's going to require quite a bit of research to figure that out. The third one being the impact of the wound dressing on local microbiota. How does that impact wound healing? There’re so many complicated factors that are interrelated here. What test houses would do this testing?

How would it be done? Can it be done on the bench? Does it require clinical study and animal study?

I worry about the time and cost that it would take to bring forward the data and what level of data FDA would really be looking for. I don't know if FTA plans to, if this were to be finalized as is, to create guidances to that effect, to help industry navigate how they're going to respond to those special controls with additional data, but it is going to require fair bit of research.

Mark DuVal: Cathy, I have a question you if in the context of those special controls, if they do require some demonstration that there's, I don't know, a low-level effect on AMR or no effect on AMR antimicrobial resistance, how does industry yet have any clue as to how they would go about that?

Demonstrating that?

Kathy Herzog: I haven't heard anyone come up with a proposal yet. I think we're all in the dark on that. Is, it's not clear definitively how you would establish that. It's not established in the literature.

Now, if you were to research current literature, there's no smoking gun that says, at least for the low and moderate antimicrobials, that there is a definitive link to AMRs. And like you said earlier, Mark, conversely, you could also look at the research, whether or not use of these localized wound dressings might contribute to the reduction of systemic antibiotics, which do have a more definitive risk to AMR.

So, it's not just research proving, you know, are you in or are you out? It's looking at the whole picture and understanding the benefit of these dressings when used in treating wounds in general.

Mark DuVal: It seems to me, too, that a study of that size is almost epidemiological in nature. And that's why I said earlier, it almost has to be an NIH study, or something funded by the federal government.

It can't fall on the shoulders of small companies. And if you ask them to do it, they're really not going to do it justice. They're not really going to establish it one way or another.

It's going to be, I think it.

Kathy Herzog: Would be paper based at that point, and then slowly it would be arbitrated through FDA as to where that evidence bar is going to fall. But I can see some delay on review times while both parties are negotiating where that evidence level needs to be. And I agree with you; there are so many complicating factors that could influence the results.

And my worry is that, excuse me, but the smaller manufacturers can absorb that cost and time, and could the market shrink to just the big players that can afford to do so?

Mark DuVal: Right. And I would add to that, Kathy, this is not like a pharmaceutical product where the margins are enormous. I used to be general counsel for 15 years of a pharmaceutical company.

I know how healthy they are. A wound dressing is. They have low margins because it's a price volume trade off. And so, they don't. They can't possibly do that. I want to mention one thing, Etienne, that I forgot to mention at the very beginning, and the reason, the technical, legal reason FDA is going about for this entire game that we're playing for reclass for, I shouldn't call it reclassification for classification, is they say, hey, 40 years ago, these were really never classified.

Well, that's true, but that's why we are calling it a de facto classification in the sense that for 40 years they've been clearing devices and they, if de facto created the standards that are already there. We all know what's required for these devices. We all know the labeling we're supposed to get or not get. We all know the studies that have to be done or not done.

And so, it's kind of a regulatory fiction on their part to say, oh, now we need to engage in classification. That's why I say it's a pretext. It's really, AMR is a cover for getting stuff that Kathy and I would fight them on, on an individual submission.

And usually they'd acquiesce that, oh, you might not have to provide that additional data when you can get common sense applied by the, usually the review staff, if not middle management or upper management, as to what you need for an individual file. But they've been asking for extraneous stuff for a while now. And I think this is an opportunity for them to do it on sort of a wholesale basis as opposed to fighting us on each individual submission as they do today.

So, I don't like that. That's the way the FDA is kind of, it's a bit nefarious. And this commissioner asked for it when he was acting commissioner back then, but he went back to his job at Duke, where his very job was to get NIH and government grants and clinical trial funds from industry. So, you wonder if there's, you know, there's an appetite to making sure that the academic community and the folks out there get lots a new corpus upon which to feed and having clinical trials, you know, but it's unnecessary in this particular product category unless they're really serious, like antibiotics or drugs being impregnated onto a wound dressing.

Etienne Nichols: You kind of used LDTs as kind of a parallel situation that's occurring. Do you, do you anticipate any additional proposed rulings coming down the pike that are kind of similar in nature?

Mark DuVal: Well, as you know, the governments the FDA has been sued on, they tried to get the valid act passed. They were unable to do it, and they were very public about it because Congress is unwilling to act. We're going to act, and they were very presumptive about their position.

And it's been a position that has been fought for decades and decades. And they just finally decided we're going to be pretty strident about our position. What Congress failed to give us, we're going to take for ourselves through regulation. And here we are. So, they're getting, they're being sued. So, you know, people are upset when FDA thinks it can become a quasi, if not quasi legislative, if not legislative body.

And Doctor Sheeran knows better. He's got behind his name an MD and a JD. So, he's both a doctor and a lawyer. And I think he should know the limitations of his role and that of the agency. But they're moving in some pretty aggressive fashions right now and on a wide variety of fronts.

I'm blanking out now, but I could probably list eight of them for you. That just astounded us. But they're taking advantage of the fact that I think they think in the fall, the administrations are going to change and they're not going to be able to take the liberties they're taking today.

Etienne Nichols: Well, I really appreciate this information. This is, this is really valuable. I think this is something people need to know more about. Where can other people, if they're interested, learn more about this? I know you have your client alerts. We'll put that in the show notes. But any additional ways they can see what, what kind of information you all put out?

Mark DuVal: Yeah, we're just, or we put, we do put our, we've put out a number of client alerts on this. I think if you really want to drill down and understand the reg, we wrote probably the second longest proposed comments to the proposed rule. And I think they're very thorough and I think they're written understand in an understandable fashion.

Other than that, I think you're going to see stuff coming out from the Washington legal Foundation. You're going to see stuff coming out from the alliance of wound care stakeholders. There's a lot of groups that are medical providers as well as a consortium of manufacturers that are very concerned about this.

And I think you're going to see lots of additional stuff coming out. We, for one, thank you for allowing us to keep the drumbeat going because we're very concerned about where the agency is headed on this. And they know that we've told them that internally as a law firm to them as our friends in the regulatory field, and we encounter these issues even in the context, as Kathy was talking about individual submissions. And we know we're going to see that ratchet up more and more. FDA always tends to get ahead of their own proposals and sort of, they sort of solidify and finalize them when it comes in the context of an individual submission, even though that guidance or regulation is not yet finalized.

Etienne Nichols: Thank you so much for coming on the podcast today. I appreciate you sharing all of this. We'll put links in the show notes to all the different groups that you mentioned so that people can dig down a little bit deeper if they like.

And we'll put links to your website as well so people can find that as well. Thank you so much, Mark and Kathy. I appreciate the work you're doing and hope to see you all next time.

Take care.

Mark DuVal: Take care, auntie and bye.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app.

Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing.

Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better.

Thanks again for listening, and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.