It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k),De Novo, 513(g), or Pre-Sub processes.
Some of the highlights of the show include:
- The difference between the 510(k) and the De Novo submissions and how to decide between them.
- An explanation of why the 510(k) submission process does not include proof of product safety or efficacy.
- Why the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process.
- How the relationship between a medical device company and the FDA resembles a poker game.
- Some statistics on the 510(k) and the PMA: How many are rejected the first time they’re submitted and why.
- When you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.
Here are some useful albeit "basic" information available from FDA:
- Watch the CDRH podcast on the de novo available here. The corresponding slides are available here.
- Watch the webinar: Regulatory Overview for Developers and Sponsors of Neurological Devices: An Introduction to the De Novo Pathway (March 22, 2017) available here.
- CDRH de novo database is found here
- De novo guidance documents:
- De Novo Classification Process (CDRH Guidance, August, 2014) available here.
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications(CDRH Guidance, March, 2012) available here.
- Medical Device Accessories and Classification Pathway for New Accessory Types (CDRH Guidance, January, 2015) available here.
Beyond the basics, here are some additional resources to begin to appreciate the strategic advantages (and challenges) of the de novo:
- Column: Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It? (MedDeviceOnline, February 5, 2014) here/ article attached.
- Column: Secrets Of The De Novo Pathway, Part 2: Is De Novo Right For Your Device? (MedDeviceOnline, February 18, 2014) here / article attached.
- Guest Editorial: The de novo pathway - Strategies and Tactics to Use and Avoid (Journal of Medical Device Regulation (May, 2015)) abstract here / article attached.
- Webinar: De Novo Pathway to Medical Device Approval: Strategies and Tactics to Use and Avoid available here. Note the corresponding handout is available upon request.
“The De Novo is not a common submission type... the total number of De Novos that have come through the FDA since it was created a dozen years ago is 186. There have been 40,000 510(k)s.”
“Most people see the regulatory processes as a series of hoops to jump through, but I don’t see it that way at all.”
“Our industry has devolved to the point where we’re treating the FDA as an elementary school teacher. This is not the way the game is supposed to be played.”
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: De Novo, 510(k), 513(g), pre-submission, which submission makes the most sense? I know it's so confusing at times, and that's why I've got Mike Drues from Vascular Sciences joining me on this episode of The Global Medical Device Podcast, to try to make a little bit of sense of these various FDA submission types and when each of them might apply to your product development journey. So I hope you enjoy this episode of The Global Medical Device podcast.
Jon Speer: Hello, and welcome to the Global Medical Device Podcast, this is your host the VP of Quality and Regulatory at greenlight.guru, Jon Speer, and with me today, I have... Frankly, you've heard him on our podcast so many times, offering all kinds of pearls of wisdom and I'm sure today will be just the same. And with me is Mike Drues, President of Vascular Sciences. Mike, welcome to the podcast.
Mike Drues: Thank you, Jon, always a pleasure to be with you and your audience today.
Jon Speer: Alright. Well, Mike, I wanna talk about a few things that have come up recently in various conversations, emails, things that I've been aware of here at greenlight.guru, and and it's right up your alley. It's all about regulatory today, and specifically we're gonna talk about some of the different FDA submissions, and the reason I wanna bring that up is because I think there is some real confusion about some of these different types of submissions. We're gonna talk a little bit about 510(k)s, De Novo, 513(g) s, pre-subs, and I was wondering first if maybe you can give a little bit of a perspective on when to submit a 510(k) versus a De Novo, where are they the same, where are they different. Do you mind sharing a few thoughts about that?
Mike Drues: Absolutely, Jon, it's a terrific question. I'm sure that the vast majority of your audience is very familiar with the 510(k), that is after all the work horse of the medical device industry. But many of them probably are not familiar with, maybe they've at least heard of the De Novo, but I doubt too many have first hand experience with it because it is used not very frequently. So let's do a quick compare and contrast between the two.
Mike Drues: So first and foremost, both are pathways to market for medical devices here in the United States, for low to moderate risk medical devices. In other words, class one and class two devices. The key difference is that the 510(k) as you well know, relies on the concept of substantial equivalents. In other words, basically, at the end of the day, we have to show that our device is basically the same as, ie, substantial equivalent to another device, what we call a predicate device, that's already on the market here in the United States. And by the way, when we say basically the same as, what we mean is both in terms of labeling as well as technology. We have to show that the device is basically the same as the other device in terms of labeling and also technology. We have to do both of those things. There is no requirement to show that a 510(k) device needs to be safe and effective, that requirement does not exist anywhere in the 510(k) regulation. In other words, you have to show that your device is basically the same as another that is already on the market. Since the other devices are already on the market, it is assumed to be safe and effective, therefore if your device do the same, it's assumed to be safe and effective. So in other words, the regulatory logic, is if A equals B and B equals C then A equals C. Unfortunately, that doesn't always work, but that's the logic that it's based on.
Mike Drues: On the De Novo side, there is no substantial equivalents. De novos are designed truly for new and novel, low and moderate risk devices. So you don't have the baggage, if you will, that you do on the 510(k) side to show that your device is basically the same as another. So with the De Novo, you're starting out with truly a blank slate when it comes to the technology and especially in terms of the labeling. In other words, let me explain it this way. So you can spin the 510(k) in many different ways but at the end of the day, you have to show as they said that your device is basically the same as another. Sometimes that's easy, sometimes that's an advantage. Sometimes it's not. In the De Novo, you don't have that limitation. You start out with a blank slate, a blank canvas, if you will, in terms of labeling. And you can paint onto that canvas literally anything that you want. Of course, you've gotta be able to prove it, you've gotta be able to substantiate it, but you can paint onto that canvas anything that you want.
Mike Drues: And that when you do this correctly, does offer some very significant competitive advantages. Because one of the disadvantages of a successful De Novo, is that a successful De Novo will lead to a predicate device, a device that somebody else can use to bring their device into the market as a 510(k) using your De Novo as a predicate. But if you create that high level labeling in a way that would make it more difficult for your competitors to do, to match, and I've got several examples, if you want, that makes it more difficult for them. So it's not as strong as a patent in the intellectual property sense of the word, but it is about as strong of a barrier to entry to your competition in the regulatory world that we can make it. So that's a quick compare and contrast. Of course, there are many other differences as well.
Jon Speer: Sure. I wanna take on a couple of things there that you talked about from a 510(k) standpoint that it's really not about demonstrating safety and efficacy, but how do you... Whenever the 510(k) requires things like biocompatibility sterilization, electrical safety, things of that nature. Wouldn't you say that those are some level of demonstrating product safety?
Mike Drues: Yeah, I guess so. You're right, good point. I should be a little careful about over-generalizing. Obviously those are all important things that you just ticked off, but to me, from a biomedical engineering perspective, those are no-brainers. Those are things that we should be doing.
Jon Speer: Right, those are givens, right?
Mike Drues: Yeah, those are things that we should be doing regardless. Let me explain it this way, Jon. So in one way, and by the way, I've got not to toot my own horn here, but I've got as much if not more De Novo experience than anybody. It's not a commonly used path. As you know, here's some numbers for you. The total number of De Novos that have come through the FDA since it was created about a dozen years ago is 186. That's the total number of the De Novos as of yesterday compared to 510(k)s, there's been somewhere in the neighborhood of 40,000 510(k)s that have come through since 1976. And just this calendar year, 17 De Novos in about the first six months of 2017. 17 De Novos have come through.
Jon Speer: Wow!
Mike Drues: So not that many.
Jon Speer: So you're the De Novo man, is what you're saying?
Mike Drues: Well, that's a nice title. I love the De Novo. It's one of my many favorite pathways to market for medical devices here in the United States, but I love all of the pathways. It's kinda like asking a parent who's their favorite child.
Mike Drues: But coming back to the safety and efficacy piece. So in a couple of ways, the De Novo is a little more difficult in safety and efficacy than the 510(k), and safety and efficacy is one. Here's what I mean by that. As I mentioned a moment ago, there is no requirement in the 510(k) that says that you must show your device is safe and effective. The reason is, the other device is already on the market. It's assumed to be safe and effective, therefore if yours is the same, then that assumption applies to you. But in the De Novo, there is no such assumption. In other words, you have to show that your device is safe and effective because there is no predicate. Now you can use, and this gets into much more sophisticated regulatory strategy, you can use, and I frequently, and De Novos use other devices as predicates, but not in the substantial equivalent sense of the word predicate. I use predicates for example, as part of my risk mitigation strategy.
Jon Speer: I see.
Mike Drues: I use predicates for example, as part of my safety and efficacy. In other words, why reinvent the wheel if there are other devices that have similar function, similar labeling, similar technology, what have you. I'll sort of beg, borrow and steal, so to speak, to use that information to mitigate the amount of new work, of new testing that I have to do. But bottom line, you are starting out with a blank slate. Maybe I shouldn't use this comparison 'cause it'll probably scare some of your audience. But the De Novo in that sense, it's like the PMA, there is no underlining assumption of safety and efficacy and this surprises people. I've got several devices that are going through FDA right now as De Novos, and that's one of the difficult things that companies have to understand. They have a hard time swallowing that pill, because they're so used to the 510(k) mentality where basically all you have to show is that your device is the same as the other person's.
Jon Speer: Yeah. Well and as you talked a little bit about that and in this bit of similarity at least on the surface between a De Novo and a PMA. I think it was you and I, we were talking once about the De Novo path. And don't let me put words in your mouth of course, but I remember leaving that conversation thinking, "A De Novo is like a patent of sorts, because you get to define the barriers to entry and you get to... It's a bit of a novelty, because the whole premise behind a De Novo is that there's not a predicate. So from a competitive standpoint, from a business strategy standpoint, there's some strengths to that because it gives you that opportunity. Obviously, there are a few more hurdles that you may have to get through on that, but can you talk a little bit about De Novo, maybe even a little on a PMA. I know a lot of people are, like you said, I think afraid of that path, because the perception is PMA, it means difficult, time-consuming, expensive, and yeah, just on the surface, a 510(k) submission is to the FDA costs somewhere around the order and my numbers are estimates, they're not exact. But somewhere in the order of 5000 whereas a PMA, if I recall, is something like 250,000 just for the submission part. But talk a little bit about some of that exclusivity that one might get with a De Novo and may be a little bit on PMA side.
Mike Drues: Well that's a great question, Jon. And by the way, since you mentioned user fees, for the moment, one small advantage, granted is a very small advantage of the De Novo, is that there is no user fee for the De Novo. Although Congress is changing that and there's going to probably be a user fee being implemented for the De Novo later this year, but for the moment, there is no user fee. And by the way, another small advantage, we may talk a little bit about the pre-submission meetings a little later in our conversation, today, another small advantage of a De Novo is that if you're going specifically for a De Novo pre-sub there are about a half a dozen different types of pre-subs, the De Novo is one of them, that has a slightly higher priority in terms of scheduling meetings than many of the others. So those are a couple of small advantages.
Mike Drues: But what you were referring to a moment ago, Jon, is something I call competitive regulatory strategies. This is a topic that I've talked a lot about and I put out some columns and some podcasts and I'd be happy to go into that in more detail. But let me just back up for a second. The best, the easiest way I can explain to the audience the De Novo, is think of a band-aid. Today band-aids are ubiquitous, but back in the day, there were no band-aids. So if we were the very first company to bring a band-aid on to the market here in the United States, Jon, what would be its default classification? What's the default...
Jon Speer: Class III.
Mike Drues: Classification of any new medical device? That's exactly right, you passed with an A.
Jon Speer: Class III.
Mike Drues: A for the day.
Jon Speer: Yes.
Mike Drues: Class III, so basically we would be treating that band-aid, we would be putting it into the same classification or risk bucket as other products like totally implantable artificial heart. Now, it shouldn't take an MD or a PhD or an RAC after somebody's name to appreciate that, "Gee, maybe it doesn't make a lot of sense to treat a band-aid like an artificial heart, to treat it to the same level of scrutiny in terms of bench top animal clinical testing and so on just because it's new." So De Novo comes down to one and only one thing, risk mitigation. We have to go into FDA and argue that yes, our band-aid is new. There's nothing like it out there. There are no predicates, but it doesn't make sense to treat it as an artificial heart, and here's why. Instead it should be a class two and here's why, or a class one, and here's why. Everything else with the De Novo is just a matter of paperwork, is just icing on the cake. That's the crux of the De Novo.
Jon Speer: Okay.
Mike Drues: So back now in terms of competitive regulatory strategy, I'll give you a quick example. A few years ago, a company came to me. They had a sterilization product that was kind of like an autoclave. Not an autoclave, but kind of like it. And they said to me, "Mike, how do we bring this on to the market?" Because they were tempted to bring it on to the market as many do as a 510(k), and there would be nothing wrong with that. In fact that's what the majority of people would do, but remember, Jon, as I've said before, average regulatory professionals know the rules. The best ones know the exceptions.
Mike Drues: I said to them, "You can bring it on to the market as a 510(k) but before you do that, think about this. You're gonna be essentially creating a me too, and therefore, why would anybody use your product as opposed to the 50 or 100 other products out there that do basically the same thing." So I said to them, "Tell me about your technology", and they did. It turns out, long story short, that they were able to achieve the same level of sterilization as their competitors but at a significantly lower temperature point. And so I said to them, "Okay, why don't we do this instead of a 510(k) as a De Novo, and we include that low level temperature claim in our high level labeling," which is exactly what we did.
Mike Drues: And remember, earlier as I said, one of the disadvantages of the De Novo is that a successful De Novo creates a predicate that somebody else can use to do a 510(k). But now we've made it more difficult for them to do that, because by including that low level temperature claim in our high level labeling, now they can't make a substantial equivalent alternate to our technology until they meet our technology. And oh by the way, if we own the intellectual property on that technology, that ain't gonna happen any time soon. So that's a very sophisticated way of using regulatory strategy to your business advantage, and at least in my experience, Jon, and you can perhaps agree or disagree, but most regulatory folks don't even think in those terms.
Jon Speer: No.
Mike Drues: They just view the regulatory process as a series of hoops that you have to jump through, and I just don't do it that way at all.
Jon Speer: Yes, you're right. I think, well, timeline is the driver sometimes and it's like figure out... And don't mishear me, and I'm sure you would agree. There's probably a whole different topic for a whole different conversation, but there is some advantage to figuring out the lowest barrier to entry from a product strategy standpoint to get a product to market, start generating revenue, but that may not be your end all be all product with all the bells and whistles. So there's a bit of art to this, but there's a lot of strategies to this, and this is why a guy like Mike Drues shines in this space because he figures out all those ways to navigate those waters, so to speak.
Mike Drues: Well, thank you, Jon. I appreciate the kind words. And speaking of strategy, and I perhaps may have used this metaphor in one of our discussions before, but I characterize the entire relationship between the company and the FDA as a poker game, in every sense of the word. And just because somebody understands the rules of poker, doesn't necessarily mean that they're gonna be a good poker player, and it certainly doesn't mean that they're gonna win the game. I wanna do everything that I can, legal of course. I don't wanna be wearing any orange jumpsuits in order to win the game. So strategy here is absolutely key.
Mike Drues: And let me mention one last thing about the 510(k) and the De Novo and maybe this will transition us into the pre-sub topic which we'll spend a moment talking about. A lot of people tell me that they have 510(k) experience and they are familiar with the 510(k), but it's also become obvious to me, after my 25 years of playing this game that many people use the 510(k), most do not use it well. And here is what I mean by that. Let me share with you some statistics for your audience. 75% of 510(k)s that are submitted to FDA today, 75% of them are rejected first time out of the box. And of those that are rejected, 85% of them are rejected specifically because of substantial equivalence or the lack thereof. And for those in the audience that are working in the PMA side of the world, it's even worse, 89% of PMAs are rejected by FDA...
Jon Speer: Holy cow!
Mike Drues: First time out of the box. They lead to what's called a major deficiency letter. I find those statistics to be appalling. They're embarrassing.
Jon Speer: It's pretty crazy.
Mike Drues: We've regrettably, and I perhaps shouldn't say this, but our industry has devolved, not evolved, but devolved to the point where we're treating the FDA as essentially our elementary school teacher; Here's my homework assignment, will you please mark it up and give it back to me? And I'm sorry Jon, but that's not the way this game is supposed to be played. And so when I see companies, especially some of the largest medical device companies on earth, announce that they've had a submission bounce back for whatever reason, I just... Perhaps I shouldn't say this, but I just kind of laugh, because virtually all of those rejections are totally avoidable by going to the FDA in advance by communicating with them in the form of a pre-submission meeting or some other way, in order to make sure that everybody is on the same page that we're pulling in the same direction. I hear a lot of my regulatory friends, they say their goal is to get their 510(k) clear or their De Novo or their PMA approved. That has never been my goal because quite frankly any monkey can do that. My goal is to get my 510(k) cleared or my PMA approved ideally first time out of the box, if I can. If I can't, with the minimum of ping pongs and Q&As going back and forth. Am I successful 100% of the time? No. But I can say that I am in the 11% to 25% and not in the 75% to 89%, and there's a lot of secret ingredients that go into my secret sauce, but the most important is communication with the agency.
Jon Speer: Okay, yeah.
Mike Drues: And one last thing, I set the bar very very high. I do it this way, if I get any question coming back on a submission, I view that as a failure, a 100% failure. Because I work really hard to get all of FDA's questions answered in advance, such that once the submission goes in, assuming that the data shows what we say it's gonna show, now it's just a matter of people putting their signatures and having it work through the system and you're done. But if you apply that standard across the board in our industry, well, almost everybody in the class would fail.
Jon Speer: Yeah.
Mike Drues: We can do better.
Jon Speer: Yeah. Those are great words. And like I said, it's probably... Considering there's a couple of other submissions that I threw out, that would be nice to get a little bit of insights on, let's transition a bit and talk about 513(g), and compare that and contrast that a bit with a pre-submission, when should you do a 513(g) versus a pre-sub? And you and I, have talked a little bit in the past, and then we have other podcast episodes and things where we've talked about that pre-submission a time or two. So folks, if you haven't listened to those episodes of the global medical device podcast, I would encourage you to look back in the archives on that pre-submission topic. But talk a little bit about 513(g) and if there's some salient points versus a pre-sub that would be great to learn some of the nuances.
Mike Drues: So that's a great question, Jon. So both the mechanisms that you're describing here, the pre-sub as well as 513(g), both of them are methods that we have are mechanisms to communicate to FDA, there are other methods beyond that as well, but those are two of them. The pre-submission meeting as we've discussed in as you mentioned, in podcast before, is basically an opportunity for you to go to the FDA in advance of your submission, how early in the process you should go the development process that's a topic of a different discussion, and you go in advance of your submission. And here's my approach: You explain to them, here's my device, here's the way it works, this is what it does, this is our regulatory strategy, this is what we're gonna say about it in terms of labeling, this is the testing that we've done, this is the testing that we are yet going to do. In other words, you lay your cards on the table, so to speak, and FDA will hopefully say, "Oh that's great, we look forward to seeing your final results and your submission in a couple of months." Or, "Hold on a second, we don't quite see it that way." And that's when the poker game, that's when the negotiation begins. So the pre-sub process is an opportunity for us to do exactly that. And by the way, the pre-sub in my book is nothing new. The guidance for the pre-sub came out, now almost III years ago.
Jon Speer: Right.
Mike Drues: But some of us were doing the equivalent of this, what I call the old fashion meet and greet, 20 plus years ago. And perhaps I shouldn't say this in a public recording like this, but I find it very unfortunate that FDA has seemed to go out of its way. This is not a criticism but just an observation, out of its way to make it more difficult, not easier, but more difficult for companies and the FDA to communicate with one another. But that's a topic of a different discussion.
Jon Speer: Yeah, but on a point though, Mike, I've worked with enough companies in my career, that there has been very few companies have actually taken advantage of that opportunity to actually have a real conversation with FDA. So maybe on the flip side of that, maybe what FDA has done is actually sparked or encouraged those companies who had this fear of FDA into having a conversation.
Mike Drues: Well, you're right, Jon. And thank you for pointing that out. I do, to a certain extent, stand corrected. The frequency of communication, in terms of pre-subs, is since that guidance was created, has increased. As a matter of fact, prior to our conversation, I checked some of the most current statistics from MDUFA. Last calendar year in 2016, there were about a little over 2300 pre-sub requests. In other words, a pre-sub meeting request. About two-thirds of them led to actual meetings, which meant about a third of them were not prepared, were not put together well enough to justify having a pre-sub meeting. So you're right, the frequency of communication, in terms of the pre-sub, has increased, obviously. What I meant, in terms of making it more difficult, is just mechanistically. In other words...
Jon Speer: I got you. Yeah, yeah.
Mike Drues: Quite frankly, why do I have to spend so much time and money preparing for a pre-sub? And let me tell you, preparing for a successful pre-sub, it is a lot of work, there's no question about it. Why can't I, just like in the olden days, call somebody up, literally, on the phone, and say, "Hey, let's talk about this for 10 or 15 minutes," and we come to a decision and we're done. Or come down there and say... Let's put it this way. As you know, Jon, I work as a consultant for the FDA, as well as Health Canada and a few other organizations. I can tell you that my best conversations that I have with my regulatory friends are not in the government building. You know where I'm going with this already.
Jon Speer: And they're not documented in pre-subs either, I'm sure.
Mike Drues: That's right, but they're held in the pubs surrounding the Beltway or Ottawa, what have you. Anyway, let's shift over now to the 513(g). So the 513(g), technically, is what we call a request for information. There's different forms of the 513(g), but I think the one that you're referring to here probably would be the request for classification.
Jon Speer: Yes.
Mike Drues: So for example, if you're working in an area where there is no predicate, like in the De Novo, as we talked about earlier, you could consider doing a 513(g) request, to make the argument that our device, it's a new device, therefore it has not been classified. We think it should be class two, and here's why. Or, it should be class one, and here's why. Unfortunately, there are user fees associated with the 513(g), they are not that high, but there are user fees. And I mentioned there's no user fees with the De Novo yet, although there probably will be. There's no user fees with the pre-sub yet, although there probably will be. I hate to say it, as everybody knows, politics aside, our government is looking for all the sources of money that they can get.
Mike Drues: So when would you use a 513(g) over a pre-sub? I'll be honest with you; in the vast majority of times, probably at least 80% to 90%, maybe more, I will be more inclined to do a pre-sub, as opposed to 513(g), for a whole bunch of reasons, not the least of which gives me the opportunity to present whatever I want, including a classification argue. Now, one of the first things that FDA will likely come back to you and say, "We can't give you a determination on classification in a pre-sub," because, after all, nothing in the pre-sub up that FDA says is binding, nothing in the pre-sub that the company says is binding. So that street runs in two directions. But what I often say in scenarios like that is, "Look, I understand that nothing is binding, and I understand that we're still early in the process, but let's take advantage of having a captive audience. We're all in the room, you've seen our information, you've heard our presentation, what is your gut feel, what is your thinking? Are we going in the same direction? Is there a reasonable chance that we can meet in the middle somewhere? Because if it's not, let's talk about it." I was in a pre-sub meeting last year, Jon, where we ended the presentation, and we wanted to have a discussion. Nobody said anything, I could hear the crickets.
Mike Drues: I got so frustrated. And again, perhaps I shouldn't say this in a recorded call. I got so frustrated. I said, "Look, we wanna have a discussion, but one of the underlining assumptions of the word 'discussion' is that there's more than one person talking."
Jon Speer: Yeah, it's two-way. Yeah.
Mike Drues: Suffice it to say, Jon, not everybody shares my same sense of humor. [chuckle] I will do whatever I can to push people gently, politely, and so on. But this is what I meant also, earlier, when I said that, unfortunately, a lot of companies are having more communication, I'm just not sure how productive that communication is, because the statistics that I just shared with you are so true.
Jon Speer: Yeah, they're so crazy. Well, folks, this is just really... We're just introducing these topics at a very, very high level. Each of these topics, 513(g), pre-subs, 510(k), De Novos, there could be week-long conferences that you can attend on the nitty-gritty details of all of these things, and of course, Mike is De Novo guy, [chuckle] but also has a lot of experience with all of these other types of regulatory submissions. The ones we've spoke about today and many that we did not. So I would encourage you if you have questions about whether or not to do a 513(g) versus a pre-sub. Or, what about a De Novo versus 510(k), or anything in that realm, I would encourage you to contact Mike Drues with Vascular Sciences. Mike, thank you for sharing some of these insights today.
Mike Drues: Thank you Jon, always a pleasure. And the very last thing I would just leave your audience with, and we've mentioned this in the past, but I think it warrants repeating is; absolutely we should all have a healthy respect for the FDA and the job that they do, but we should absolutely not fear them. And we should not fear going to talk to them in advance of our submission. Whether you do it using a pre-sub or a 513(g) or some other thing else, quite frankly, I could care less. The most important thing is that we have a communication, have a dialogue. Kind of like you and I are talking about right now.
Jon Speer: Absolutely.
Mike Drues: We have a discussion. Because if you don't, then you run the risk of just becoming another one of those statistics. And obviously, the excess time and money that it takes to get your device on the market, that adds up very quickly.
Jon Speer: Absolutely. And thank you for sharing that. And folks, greenlight.guru, we're here to help simplify some of those processes that you have to deal with. Yeah, as you're preparing for this regulatory submission, there are things like design controls and risks that you should be working on, because in a lot of these submissions, you need to be able to demonstrate things like substantial equivalence or safety or efficacy and those sorts of things. And that's, in a large respect, the basic premise of what design controls are all about. And risk is certainly an important element in the device development and the device manufacturing, these days as well. So we built our platforms to help with that, but it's got a whole lot more than that. If you're gonna need that quality system as you go to market and greenlight.guru is here to help you with that. So if you like to learn more about our software platform and how it can help, you can always reach out to us. Go to greenlight.guru and request more information and somebody from our team would be happy to have a conversation with you. So, thank you again to Mike Drues, Vascular Sciences. This is Jon Speer, the Founder and VP of Quality and Regulatory at Greenlight Guru, and your host of the Global Medical Device Podcast.
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