Understanding FDA's New Intended Use Rule and its Implications

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.

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Some highlights of this episode include:

• When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.
• High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.
• High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.
• Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).
• Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.
• The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.
• Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.
• Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.

Links:

FDA finalizes long-awaited intended use rule

FDA Delays Implementing Parts of 'Intended Use' Rule

Federal Register’s Regulations Regarding “Intended Uses”

FDA - Center for Devices and Radiological Health (CDRH)

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from this episode: 

“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues

“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer

“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues

“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike Drues

Transcription:

Announcer: 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.

Jon Speer: All right, on this episode of the Global Medical Device Podcast, I reconnect with Mike Drues with Vascular Sciences, and we talk about this, I guess a policy is probably a good word from FDA, about the long-awaited intended use rule. We'll provide a few links to the FDA federal register and some of the articles that support or discuss this a little bit more in-depth to support the conversation that Mike and I have. But just to give you a little bit about this, and I'm reading from the summary from the federal register, FDA is issuing a final rule to amend its medical product intended use regulations. This final rule amends FDA's regulation, describing the types of evidence relevant to determine whether a product is intended for use as a drug or device under the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from pre-market notification is intended for a new use. But anyway, I don't want to continue to spoil the fun that you're about to have while listening to this, but Mike and I do to talk a little bit about indications for use versus intended use, as well as this term, manufacturer's objective intent. So we really unpack this and the role that labeling plays in this new rule. So I hope you do enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder, Jon Speer and joining me is a familiar voice and hopefully by now familiar face on the Global Medical Device Podcast, is Mike Drues with Vascular Sciences. So Mike, welcome.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience.

Jon Speer: So this one's interesting to me, there was some recent news that was posted. I think I saw it on RAP website. I think it's probably in a few other places, but we'll provide links to those, but the gist is FDA finalizes the long waited intended use rule, and not going to lie, the first reaction I had was I started scratching my head. I'm like, why do we need a new rule about intended use? I don't know if that's a great place to start, but we're going to unpack this whole topic here today. But maybe we can leave it as a rhetorical question unless you have a reaction to that initially.

Mike Drues: Well, I think, Jon, we should build up to that.

Jon Speer: Okay. Fair enough. All right. So maybe a good place to start, intended use, what do we mean by labeling, when we unpack this document information about this it talks about high level versus low-level labeling and things of that nature, but what do we mean by that when we talk about labeling?

Mike Drues: Great question, Jon, and on the surface labeling seems like a simple, straightforward topic, and I want to start by just reviewing a couple of basic points first, but for the benefit of the audience that does understand something about labeling, I don't want anybody to just kind of tune out now because they think this is just labeling 101. Because this is going to get very complicated very quickly. And quite frankly, for example, manufacturer's objective intent, most people have never even heard of that phrase, let alone understand what it means. So we're going to get there. We are going to unpack this as we go. So let's start out with the basics and then we'll dig deeper. So when we refer to labeling, at least when I refer to it, I'm not talking about the sticky piece of paper that we stick on a package or on a box that a medical device comes in, nor am I talking about the graphics that go on to that label. Those are all important aspects of labeling, but that's not what we're talking about here. What we're talking about here, Jon, is the content of the label. In other words, the words that we use, the claims that we make. And when it comes to labeling, I break the labeling universe into two parts. What I call high-level labeling and low-level labeling. Now to be fair, Jon, these are not FDA- isms. These are Mike Cruz- isms. High-level labeling, that is the most important part. That's the intended use, the indications for use, label claims and so on. That's what I mean by the high-level labeling. As opposed to the low-level label, that would include things like the directions for use or what some people call the instructions for use. And by the way, Jon, I really don't like to use the phrase instructions for use, even though many people, including FDA, uses that phrase. Why? Because the acronym, instructions for use, IFU, it gets very confusing with indications for use. So then I prefer to call it directions for use, DFU, as opposed to instructions for use, IFU. So the low-level labeling would be the directions for use, the package inserts and so on and so on. And if I may, Jon, I'll share with you a quick story from one of my pre-sale experiences. I use the phrase low level and high-level labeling in an FDA. One of the FDA reviewers was not familiar with that, because like I said, these are Mike Cruz- isms. These are not FDA- isms. So he asked me, " What do you mean by that?" Before I could even answer, one of the other reviewers in the room, oh, by the way, happened to be a former graduate student of mine, explained what high level and low-level labeling meant. And he kind of smiled.

Jon Speer: There you go.

Mike Drues: And so sometimes it's a bit of an advantage actually to have a former grad student of mine who now works at the FDA. I guess I'm getting old, Jon, because I have a number of former graduate students who now work at the FDA, but does that make sense in terms of labeling and a high level and low-level labeling?

Jon Speer: Yeah. I guess it had to feel a little bit good that something you taught stuck with that person so that they could explain it. So that's encouraging.

Mike Drues: Indeed.

Jon Speer: Yeah. I want to echo, I guess disclaimer, the statement you made when you first started talking about labeling. I do think a lot of times people hear this and they tune out." Ah, it's just a label. Why is this a big deal?" Well, there have been numerous and continues to be numerous warning letters, recalls, et cetera, et cetera, et cetera, that are strictly related to content or lack thereof or misinformation that's on labeling. Whether that be the high level or low-level labeling. But yeah, totally makes sense. I guess to talk a little bit more, distinguish a little bit more between high level and low level, do you think you can use high-level versus low-level labeling as some sort of strategic competitive advantage? I mean, are there ways to leverage information that's on either the high level and/ or the low-level labeling to minimize or streamline some of the regulatory impact?

Mike Drues: Absolutely, Jon, it's a great question. In fact, I do it all the time. One of the big reasons why I do it is because it will minimize regulatory burden. Before we talk about how we can use high versus low-level labeling as a strategic advantage, regulatory burden, these phrases that I use a lot, but not everybody really understands what it means. Obviously, Jon, you're a pretty savvy guy. If I could put you on the spot a little bit here, what do you think regulatory burden, at least what does it mean to you?

Jon Speer: Well, I mean, to me it implies that the words that I choose or the words that I choose not to use, especially when it comes to what I'm claiming regarding my product features, aspects, details, indications for use, et cetera, et cetera, that that becomes very important. Sometimes the difference between word a and the word the might make a big difference in the eyes of a regulator. So I want to be very intentional about the use of the words, the symbols, all the details that I put in that, because if I choose one set of words or path, then it can be perceived completely differently in the eyes of regulatory bodies such as FDA versus if I use some other choices.

Mike Drues: Yeah, I think Jon, that's a good start. I think I would ostensibly agree with what you said. Let me offer a slightly different spin on the concept of regulatory burden. To me, regulatory burden simply means how much work do we have to do in terms of either benchtop testing, animal testing, clinical testing, literature, evidence, and so on. How much work do we have to do in our product, through the FDA and onto the market. And in this particular case specifically, how much work, how much evidence do we need to support our labeling claims? Well, the answer to that question, Jon, is it kind of depends where we put our claim. Remember, as we talked about at the beginning, labeling as a broad universe, we have high-level labeling, we have low-level labeling. Simply put, if we put a claim in the high-level labeling, in the intended use or the regulatory burden, that is the amount of effort or work or data that we're going to need to support that claim is going to be very, very hot. On the other hand, if we put exactly the same claim in our lower level label, for example, the directions for use or the device description or something like that, then it's going to have a much lower regulatory burden. In other words, much less evidence will be necessary to support exactly the same claim. It's a strategy that I use frequently to minimize my regulatory burden. As a matter of fact, I'll share with you another recent example, Jon. We went to the FDA with a precept, this was just about two months ago, where I didn't feel that the company had enough evidence to support a particular claim in the high-level labeling. So instead I suggested that we put it in the low-level labeling, because we've got a precept coming up, let's float this idea at FDA to make sure that they're okay with that. Long story short, Jon, FDA came back and said," Yeah, absolutely. We have absolutely no problem with you putting this claim in your low-level labeling as long as you have the evidence," not necessarily direct evidence, because we were just using literature evidence, not new or direct evidence to support it.

Jon Speer: Interesting.

Mike Drues: So a claim is a claim, whether we put it in our high-level labeling or our low-level labeling, we can still advertise for it, but there is a caveat, and that is we have to be a little bit careful how we advertise a claim that is low- level labeling, but not in our high-level labeling. That's perhaps a topic of a different discussion. But bottom line is we can advertise claims regardless of where they are, but we have to do it differently. We have to be very careful about advertising claims that are not in our intended use or our indications for use.

Jon Speer: Sure.

Mike Drues: That make sense, Jon?

Jon Speer: Yeah. We've sort of talked loosely about this, I guess as an idea or philosophy, but there's a lot of art in regulatory, and to me what you just described is some of the artistic skills that you apply to high-level and low-level labeling, but you did mention something-

Mike Drues: Jon, I'm very flattered. I think you're referring to me as an artist.

Jon Speer: A scientist and an artist. I mean, is that even possible? That means you're using both the left brain and the right brain, I think. Right? But yes, you're welcome.

Mike Drues: I would like to think so.

Jon Speer: You mentioned this a couple of times, the last explanation, and if memory serves, I think it is also the topic of one of the very early conversations that you and I did on the Global Medical Device Podcast, but let's talk about it. Remind folks. Indications for use, intended use. What's the difference? How are they the same? So go.

Mike Drues: Yeah. Great question, Jon. And there's a tremendous amount of confusion about this, not just in industry, but at FDA as well. As a matter of fact, you mentioned one of our early podcasts that we did about labeling. I think we've talked about labeling off and on a number of times over the years. One of the webinars that I did on this particular topic is actually now posted on CDRH's internal website for their reviewers to watch because there's so much confusion about the difference between intended use and indications for use. There's a lot of people, including at FDA, who think they understand the difference, but they really don't. As a matter of fact, I've seen submissions that have gone through the FDA, 510Ks and PMAs and so on, where the labeling is flat out wrong. I point out to the agency that it's wrong and they say," Yes Mike, we agree with you, but we can't change it." That's our US government hard at work. I'm sorry to say it, but it's true. All right. So back to your original question, what's the difference between intended use and indications for use? It's really not nearly as complicated as a lot of people think. Intended use focuses on the product or on the device itself. In other words, what does the device do? How does it work? What's its mechanism, so on and so on. So intended use is all about the device. Whereas indications for use, the focus is on the patient. What illness, injury, or disease or condition does the device, is it intended to prevent, diagnose or treat? So let me just repeat that one more time. Intended use, the focus is on the device. What does it do? How does it work? Its mechanism of action. Indications for use focuses on the patient. What condition, illness or injury is the device intended to prevent, diagnose or treat? Unfortunately, Jon, there's a lot of inconsistencies across CDRH. In other words, in some cases you'll see in submissions where the intended use and the indications for use are separate and defined as I just did. In other cases, they use what I call a blended intended use indications for use statement where it's all kind of mushed together in one piece. Unfortunately, in spite of what some of the politicians at FDA will have you believe when they say everybody's following the same rules the same way, it's just absolutely not true. Anybody who believes that is just naive, because the labeling is just one of many examples of that. So my best advice, and I say this to companies all the time, whatever part of FDA that you're working in, whatever part of CDRH that you're working in, depending on if it's cardiology or urology or gastroenterology or whatever it is, take a look at the submissions that have come through recently in that area and see if they prefer separate intended use and indications for your statement, which is my personal preference, or do they prefer a blended intended use indications for use statement? I'm happy to do either one, but make sure that you get in agreement with them. And if you're going to do a pre sub, you know, Jon, I'm a big fan of the pre subprocess, bring this up in the pre sub as well. Make sense?

Jon Speer: Yeah. On that last point, I mean, do your homework, understand how other similar type products have been addressed or handled or viewed from a regulatory perspective. It sounds like certainly something you'd want to discover or uncover during the conversation the pre sub as to how this particular product would be reviewed and what the FDA's desire expectation... Because it seems silly at times I suppose, but those words do matter and how it's viewed is going to matter from the perspective of FDA. I've seen a lot of submissions at the late stages of when you're waiting for that clearance letter and there's this back and forth, back and forth on wordsmithing and things like that. Then it's just, get that answered earlier, I guess, is what I'm trying to say. So let's get onto this long-awaited intended use rule, and why it is so important to medical device manufacturers. For example, is labeling simply limited to what I'm going to say and put on my label? I guess the other part of this, a little tongue in cheek, is this really a long-awaited intended use rule that we've been waiting on?

Mike Drues: Well, now we're really going to start to get into the meat of this discussion, Jon, because unlike a lot of people believe, labeling is absolutely not, underline not, limited to what you say or what you print on your labeling. Labeling goes well beyond that. By the way, this is not unique to medical devices. This is equally applicable to drugs and biologics as well. As we get into the details of this, Jon, as an engineer we like to think in terms of root cause. Well, what's the reason why this intended use rule, so to speak, has been under such discussion and debate? Actually it goes back to at least 2015, if not before. But the root cause is that, myself included, have gotten quite clever in our wordsmithing. That is we say or we claim one thing, but we infer or we imply another thing. Let me say that one more time, because this is a little bit of a cat and mouse game, to be honest with you, industry versus FDA. Industry, and I spend some of my time designing labels. I don't mean in the graphical sense, but I mean in the wordsmithing sense. We say or we claim one thing, but we infer or imply something else. So for example, and I'm going to purposely use some non-medical device example. If you remember, Jon, years ago when we were in college, there used to be a soft drink on the market called Jolt Cola, that used to advertise all the sugar and twice the caffeine. They didn't make the claim that the caffeine would make you stay awake, because if they made that claim they would have to prove it. So instead of listing it as what I call a stated claim, they used it as an inferred or an implied claim, because everybody knows that caffeine does exactly that. Similar example, there was a product on the market a few years ago called Lazy Cakes, which was basically a brownie that had melatonin in it, and they actually got smacked by the FDA for making certain claims, but they were also taking advantage of an inferred or an implied claim that melatonin would help you relax, would help you go to sleep. That's why they called it Lazy Cakes. And by the way, I've come to appreciate, this is a very subtle but very powerful regulatory strategy, Jon. If you include in the name of your product what you want to advertise without including it as a formal name, that's a very clever way of getting that into the minds of your customers, because FDA does not regulate, at least not yet, the names of medical devices. So you can embed a claim in the name of your device without it being subject at least directly to FDA regulation.

Jon Speer: Interesting.

Mike Drues: So anyway, that's a start, happy to dig deeper, but let me pause and see if that much makes sense.

Jon Speer: Yeah. So far I'm tracking with you, for sure. So do we want to continue to dive a little bit deeper on this long-awaited intended use rule? Or should we maybe dive into more of what does this mean from a manufacturer's perspective? I guess specifically, I'm using quotes here, I believe this comes from some of the literature about this manufacturer's objective intent. What does that mean?

Mike Drues: Yeah, great question. And I love this phrase. Jon, this is just starting to get into now is quite frankly one of the reasons why I love to work in regulatory, because this is the epitome of the fuzziness of the gray area. So many people think that regulatory is just black and white. If it was it would be boring, and quite frankly I would never be working in it. Because I get bored when things are black or white, true or false, right or wrong. There's an infinite number of shades of gray. Now we're getting into those infinite numbers of shades of gray. So as I mentioned a moment ago, Jon, this debate goes back to at least to 2015 that I know of, I suspect probably earlier than that. Around that time, FDA introduced this new phrase called manufacturer's objective intent. What the heck does that mean? Manufacturer's objective intent basically means that if a manufacturer knows or has knowledge of the facts that would give the device or the drug company knowledge that the product would be used for conditions or purposes other than what is being advertised for, in other words claimed, then the manufacturer may be required to provide adequate labeling for that particular drug or medical device in order to support those claims. So this is what I meant a moment ago, Jon, goes well beyond what you literally say on your label. This went back and forth between FDA and Congress and industry, several times they modified this in the next generation, and we can provide references. I know there's a lot of words that probably is difficult for the audience that are just listening or watching it, but we could provide references. It was modified, FDA came out and said, and I love that legal phrase, Jon. I use it all the time." The totality of the evidence establishes that a manufacturer objectively intends that the medical device introduced into interstate commerce," in other words put onto the market," is to be used for conditions, purposes or uses other than the ones for which it has been approved or cleared or granted market authorization. For such drug evidence to support those other intended uses." So bottom line, the manufacturer is not limited to just simply what they say on the label. In other words, what I referred to earlier as the stated label claim, but they could also be held responsible to support inferred or implied label claims. Fast- forward to today, Jon, in 2021, the new language is now coming from FDA, and this is after they took all of the suggestions from industry. It's interesting to note, Jon, that FDA actually dismissed or did not follow a lot of the suggestions that were provided by industry. So fast forward to 2021, this new rule so to speak, basically FDA is now saying that medical device companies would not be regarded as pending an unapproved new use of an approved or cleared medical device based solely, and I think that the interesting word here is solely, on the firm's knowledge that such a device was being prescribed or used by healthcare providers for uses other than what's on the label itself. In other words, knowledge of an unapproved use would not by itself trigger obligations. One last thing I'll go on to mention, Jon, and I know there's a lot to digest here so we can talk about this a little bit. FDA says that while they agree that laws must give a person of ordinary intelligence, that's the way the lawyers write this, a person of ordinary intelligence a reasonable opportunity to know what is prohibited, FDA went on to say that meticulous specificity, that's the phrase they use here, is not required. You're probably familiar with the phrase that FDA uses a lot, Jon, enforcement discretion. This clearly opens the door or keeps the door wide open for enforcement discretion. So let me try to summarize what I just went through, Jon, and then we can discuss it. Because I know this is not nearly as simple or straightforward as a lot of people think. Simply put, a manufacturer is not limited to supporting what is stated on their label in black and white. The manufacturer may also be required to support claims that are inferred or implied, especially if the manufacturer has knowledge that that particular device is going to likely be used for those things anyway. In other words, in the past, Jon, many people, myself included, would argue that that is clearly off-label use, and it is beyond FDA's authority to require a company to support an off-label use of their product. But this new, if it is a new policy, if you will, really brings that whole discussion of label claims and off-label use into question. I know I went through an awful lot, Jon, I'm sure it's probably about as clear as mud. What questions do you have? How can I kind of clarify this?

Jon Speer: Yeah. So definitely lots of shades of gray in what you just described. You and I've talked about this example in the past, but as you were describing some of the nuances I was reminded from many years ago in my career, a lot of companies who are developing stents. A stent for those listening that may not know, it's more or less a mesh metal tube that has a few different indications or possible abilities for indications throughout the human body. One of the most notable use cases for a stent is in coronary arteries, to open up stenosed arteries. Once upon a time, the loophole I think that a lot of companies pursued with those stents was, oh, let's bring it to market under a biliary duct claim, completely different part of the body. I suspect, this is speculation, but I suspect full well knowing that it was going to be used in a coronary application.

Mike Drues: I'm sorry, Jon, there was a little static on the line. I didn't hear what you just said, and please do not repeat it.

Jon Speer: I have no evidence one way or the other.

Mike Drues: Purely hypothetical.

Jon Speer: Purely hypothetical. But it was suspicious. Once upon a time I think there were more biliary stents cleared than there were actual biliary procedures done annually that required stinting. But that is maybe an extreme example. To remove some of the suspense, those loopholes have been addressed. I think that this is a progression of that, what you just described about the objective intent. I mean, that's a clear case where a company knows, they know that it's being used and they have a responsibility or an obligation to address that.

Mike Drues: I think you're spot on. I'm so glad you brought up that particular example because let's use that as an example to illustrate how things were different then and now. Okay? So years ago, you may remember Jon, when I started out in this business as an R and D engineer, almost 30 years ago now, I actually designed stents among other things. So this is an area near and dear to my heart. Pardon the pun. So 20 or 30 years ago, if we went to the FDA, as you just suggested with a biliary stent, that was indicated for biliary use, and FDA said," Well, what if somebody put this in a coronary area instead?" From a regulatory perspective, I could very easily push back on that, and I was guaranteed a hundred percent to win in simply saying," You know what, if a physician chooses to put this in the body in some place other than a coronary artery, they can certainly do that."

Jon Speer: It's the practice of medicine.

Mike Drues: It's the practice of medicine. That's exactly right. And FDA doesn't regulate the practice of medicine, the manufacturers control all the devices to be used and so on. So it'd be very easy to push back. But now with this quote-unquote new policies to try to, as I said at the beginning, Jon, to FDA's credit to try to get control of this bit of a cat and mouse game, FDA does have now more statutory authority, more ammunition to push back on the manufacturer and say," You know what, you're right. It's not in your labeling." However, if you know, or you should have known as the lawyers like to call it, that people might be using it, or people will likely be using it in this particular off-label use, then we have the right, we have the responsibility, some might say, to ask for data to support that. So that's the subtle difference. Maybe not so subtle difference, a very easy argument to win regulatory speaking versus today. I think decent chance of winning the argument, but not nearly as easily. I think now as more products are going to come onto the market, I think this is going to continue to go back and forth with the court. So I guess time will tell on all of this.

Jon Speer: Yeah. Do you think it's worth going through maybe another example to illustrate this? Or should we-

Mike Drues: I think Jon, maybe we can wrap this up by talking about just a brief couple of other aspects of this discussion of labeling that are important. There's two that I wanted to just bring up in particular. The first one is thinking beyond regulatory terms, from what are the product liability implications of your device being used for purposes other than what's on your label. You know, in the past we would call that off label use. But now we have this phrase manufacturer's objective intent. I think we've talked about this a little bit before, Jon, there's nothing new here. Because, as you know, I spent some of my time working as an expert witness in medical device product liability cases exactly like this. I'm not limited to uses that are directly stated on the FDA cleared or approved label. If I can show that the manufacturer knew or should have known, or as my attorney friends like to say were thinking about these other uses of this device, regardless of if it's on the label or not, and something bad happens to the patient as a result of that use, then Jon, I hope it doesn't take a JD from Harvard law after your name to appreciate, kerching, kerching, kerching. This is exactly the concept of manufacturer's objective intent, as we're talking about here. So the product liability implications are important. Go ahead, Jon, I'm sorry.

Jon Speer: No, I was just going to say, going back to my comment about there's art to this, and you have often stated it's not the regulatory body that I should be afraid of or worried so much about. Of course that's important, but I need to think about it more from a litigation perspective. I mean, it's product liability. This can be, like you said, kerching, kerching, kerching.

Mike Drues: Absolutely. I run into a lot of people who think that if they don't list a particular indication on their FDA cleared or approved label, and somebody uses their device for that indication and they're harmed, the patient is harmed and sued, that all they have to say is," Sorry, it's not on my label, end of discussion." Well, for better or worse, Jon, at least here in the United States, the legal system is not nearly so simple. So there are implications. The other thing that I wanted to bring up very quickly, Jon, beyond regulatory, is the reimbursement implications. Because simply put, and you and I did a recent podcast where we took a deeper dive into reimbursement. It's another very important and very complicated topic. But simply put, if you want reimbursement on something, you need to state that on your label. In other words, as you know, Jon, I work as a consultant for the FDA. I usually work as a consultant for CMS, for the Centers for Medicare and Medicaid Services. Simply put, CMS is not going to reimburse you for an inferred. In other words, if you want to get reimbursement, you've got to state it on your label. This is why when we design our label, and one of my most popular webinars is one called design your label like your design your device. And I don't mean in a graphical sense, Jon. I mean in the wordsmithing sense. We have to balance regulatory concerns with product liability concerns, with reimbursement. You know, many of these things can be diametrically opposed to one another. So bottom line, there's a lot more to this whole discussion of labeling than just the regulatory implications.

Jon Speer: Yeah, I just want to highlight to folks, because I think reimbursement is another one of those things that is often forgotten or certainly put off until very, very late in the game. At least in the United States, generally speaking, if you want to get paid for your products, that means the person using the products, generally speaking, not a hundred percent, needs to have some sort of means to get reimbursed for using your product. So that's why that reimbursement component is so important. So that to me, that's not the only, but that's another reason why this content, this policy that's being proposed, that's a pretty important aspect. I know of course everyone listening wants to improve their quality of life, but you also want to run a good business that generates income so you can continue to make product improvements and additional products too.

Mike Drues: Are you suggesting, Jon, that the medical device companies out there and the people in them are in this business not simply for altruistic reasons?

Jon Speer: Mike, I hope there's an element of altruism, but you are running a business. I'll dodge the question, hopefully elegantly-

Mike Drues: It was a rhetorical question.

Jon Speer: That's rhetorical. But as a product development engineer, I want to work on new product development devices. But if our company isn't getting revenue, then things like R and D budgets might be cut. So that removes some of the opportunity that I get to work on new and exciting things. So it's okay to make money. It's okay to help people at the same time. There's nothing wrong with that.

Mike Drues: Absolutely.

Jon Speer: All right. Anything else that you think is important that we should leave folks with regarding this long-awaited intended use rule before we wrap things up today?

Mike Drues: Just a few takeaways. We went through a lot, and some of this is pretty complicated, but just a few high-level takeaways I want to remind our audience. First of all, please don't be so naive as to think that your labeling is simply limited to what you say on your sticky piece of paper that goes on your back. Labeling is a heck of a lot more than that. It's a heck of a lot more than just wordsmithing, because as we just talked about, especially in the second half, Jon, it's not just what you say, but what you have knowledge of. So make sure that you know what all of your options are, make sure that you can identify the advantages and disadvantages of each and every one of those options. If that's not your area of expertise, that's fine. None of us can know everything. Make sure that you get somebody on your team like Jon or like myself or somebody that quite frankly knows what the heck they're doing to help you, to advise you on this. Keep in mind, Jon, this drives me crazy about so many regulatory professionals. Let's be honest, in many organizations, regulatory is viewed as the police because they're constantly telling R and D or other places what they cannot do. And I'm sorry, I do not take that approach. I say you could do whatever you want. Specifically when it comes to labeling, you can say or you can claim whatever you want, as long as you can prove it, as long as you can support it. So if you want to claim that your new medical device cures cancer, or regrows missing limbs, then terrific. I say go for it. But before you start saying that, the first thing that you got to do is you got to prove it to me as a biomedical engineer, that your technology can do those things.

Jon Speer: Yeah, absolutely.

Mike Drues: There's two other things to wrap up, Jon, and then if there's anything else that you think is important, feel free to add it to the list. Don't just focus on what you say in your label. Also consider what you don't say and how you don't say it. In other words, it's not just what you say that matters. It's what people hear. I'll say that one more time. It's not what you say that matters. It's what people hear. This is a skill that many politicians are very, very good at. And this is also a skill that good regulatory professionals, I'm not talking about average regulatory professionals, good regulatory professionals are also very, very taking advantage of not what you say that matters, but what people hear. I hope, Jon, the audience really appreciates the power of those messages because we're definitely in the gray area. There's nothing that we've talked about here today that's black and white. And the question is, how do we use that gray area, that vagueness, that ambiguity to our advantage? That's what this discussion hopefully was all about. Anything that you would add?

Jon Speer: As usual you're thorough and complete on these types of topics. I think I just would remind or reiterate to folks that there is art here. I've mentioned it a couple of times. Labeling should not be treated as a cookie cutter approach. Just because you've done it this way for similar products in the past does not necessarily mean that that's the best way or the way that you should continue to move forward. I think it's a great opportunity to learn and to maybe adapt and revise your approach, because there could be some advantages to doing so, there could also be some disadvantages to continuing to do the same thing over and over the same old way. So as Mike mentioned, he is extremely knowledgeable in designing labels. And again, that's not just laying out the different symbols, it's about the wordsmithing components and about architecting your high level and low-level labeling in a way that makes the most sense for what you want to do with your product and what you want to claim and all those sorts of things that are important to your medical device. So Mike Drues of Vascular Sciences, as per usual, has provided a wealth of knowledge and information on a very important topic that we should be paying attention to, and want to thank him for his contributions today. So thank you, Mike, for that. As always, this is your host and founder, Jon Speer, and you have been listening to the Global Medical Device Podcast.

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