How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the abbreviated path, it’s likely an accurate assumption that many don’t know how to use it.

Today, Mike Drues, the president of Vascular Sciences, and Jon Speer are going to delve into the abbreviated 510(k) path and how it can benefit you.

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Some highlights of this episode include:

• The three principal types of 510(k)s and how they differ from one another.
• The crux of the abbreviated 510(k) and how the documentation of substantial equivalence differs from how it’s done for the other types.
• The most current statistics on how much the abbreviated 510(k) is used and Mike’s thoughts on why the number has dropped.
• The review times for the abbreviated vs. the traditional 510(k).
• Information on the format and content of the abbreviated 510(k).
• Why it’s important to show why the consensus standards are applicable even though the regulation doesn’t require it.
• Why many 510(k) submissions are rejected.
• What’s happening on a regulatory perspective in other parts of the world as well as Mike’s thoughts on alternatives to the 510(k).
• The importance of thinking outside the box when it comes to regulatory matters.
• Mike’s best advice for those preparing to submit their documentation: Be aware of all of your options and the advantages and disadvantages of each.

Links:

Mike Drues on LinkedIn

Vascular Sciences

Use of Voluntary Consensus Standards guidance

Content of a 510(k) guidance

Acceptance Checklist

Memorable quotes by Mike Drues:

“I pride myself on thinking outside the regulatory box.”

“A very small number of the 510(k)s are brought to market as an abbreviated 510(k)... Just because something is seldom used doesn’t mean that it doesn’t have significant advantages.”

“Abbreviated might not mean what you think it means. It does not mean less time or less work.” 

transcription:

Recorded Intro: 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:        An abbreviated 510(k).

                        Do you know what this is? Do you know how to use this and leverage this potential pathway for getting your product to market?

                        Well, if you're like most, the answer is probably not. Did you know that only two percent of 510(k)'s have gone via the abbreviated 510(k) path? Not very many people are using this approach. Maybe it's a viable opportunity for you.

                        So, today's episode of the Global Medical Device podcast, Mike Drues, from Vascar Science and I dive into different types of 510(k)'s and specifically go a little bit deeper into understanding the abbreviated 501(k) path.

                        Hello, and welcome to the Global Medical Device podcast. This is your host, the founder and VP of the Quality and Regulatory [inaudible 00:01:21], Jon Speer. And today we're going to dive into a topic that, you know, frankly I bet few of you even really know the nuances of this topic, and that's why we're doing it today.

                        The topic is centered around the FDA's abbreviated 5010(k). You may not have even known that such a thing existed. And with me to dive into the details of this topic is my good friend Mike Drues a Vascular Scientist. Mike, welcome.

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

Jon Speer:        Alright, so Mike, you and I recently had a discussion on this [inaudible 00:02:04], this new syndicate that is in the recent press from FDA, the fast track to 510(k) and during the course of that discussion we postulated that based on what we were reading and observing and speculation that "boy, this really sounds like an abbreviated 510(k)". So, we talked about and thought "hey, might be a good topic to educate the medical device industry a little bit more on the abbreviated 510(k)".

Mike Drues:      Well, you're exactly right, John. I think this conversation dovetails quite nicely on what was announced this past December, what's being marketed as sort of the new 510(k) alternative, and in our last podcast you and I both discussed that maybe this is really not as new as some people would like to think. It's just sort of highlighting what we've had for a very long time, and that is the abbreviated 510(k).

Jon Speer:        Yeah, and I guess that might be a good place to start. Let's dive into what are the different types of 510(k), and how do they differ. So, can you take a moment and give a little bit of an overview of the different 510(k) types?

Mike Drues:      Absolutely, Jon. So obviously everybody in the audience is very familiar with the 510(k). Here in the United States it's clearly the workhorse of the medical device industry. In fact, the vast majority of medical devices that come onto the market, greater than 90% of them, are brought to market under this 510(k) program.

                        What a lot of people don't know, is that there's different types of 510(k)'s. So, the three principle types, just to quickly review.

                        First we have the traditional. Second is the special, And then the third, which is the topic of today's conversation, is the abbreviated. Now just to set the stage so we can do a little compare and contrast, let's do a, sort of a quick review in compare and contrast of these three types.

                        So, starting with the traditional. This is the most common. This is the one that most people are probably familiar with. The essence of the traditional 510(k) is that we have to show Substantial Equivalence, Substantial Equivalence is important in all 510(k) types. What we show is Substantial Equivalence to an existing medical device, a so called predicate device. A device that's already on the market hear in the United States. It could be one of our previous devices, or it could be a competitor's device. So, a traditional 501(k) involves showing substantial equivalence to an existing device.

                        A special 510(k) ... the difference there is it can be used in a few different circumstances but the most common circumstance, and I know, Jon, you and I both have a lot of experience doing this, is when we have a device already on the market, and we make some sort of a change or modification to it. So, rather than submitting a full blown traditional 510(k) to let FDA know of our change, and by the way that change could be either in labeling, or design, or manufacturing technique. Instead of doing a traditional 510(k) to let FDA know about that change, we do what's called a special 510(k), and again, that's the topic, really, of a different discussion. But the emphasis there is to show that that change in our design, or what have you, is still substantially equivalent to our existing device, already on the market.

                        So, a moment ago I said with the traditional your predicate can be on of your existing devices or a competitors, for a special 510(k), almost by definition the predicate needs to be your existing device. I'm not sure you could make a change to a competitor's device and submit it to the FDA as a special 510(k). It's and interesting question, Jon, but I'm not sure if we could do that.

                        And so, any questions or comments on the first two types, Jon, before we get into the abbreviated?

Jon Speer:        Yeah, just a comment, so folks ... Mike is I would say a specialist, a Ninja, so to speak, when it comes to regulatory strategy and a lot of companies will leverage traditional 510(k)'s as maybe a first entry, so to speak, into the market, and then leverage the special 510(k) as they make enhancements or improvements to their products. A lot of pros to that. Sometimes there are cons to that, but certainly as you start to figure out your strategy, Mike Drues from Vascular Scientist is a guy that you should reach out to and chat with about that.

Mike Drues:      Well that's very kind of you to say, Jon. Thank you very much. And I'm curious because you've got obviously a lot experience in this industry. This is something that I just thought of, literally in the last few seconds. Do you thing it's possible for a company to submit a special 510(k) based on a change or modification to a device that they do not own, but it's a competitor's device. So a competitor has a device on the market. You're company wants to make a change to that, and therefore you submit a special 510(k) as opposed to a traditional, do you think that would even be possible?

Jon Speer:        Well, you know, you want to talk about possible fast tracks, potentially that's a pretty innovative way to think about it. I mean I don't have any first-hand experience doing so, and I'm not aware of anybody doing so, but I can assure you that after we chat here today that I'm gonna dive into that a little bit. I wonder if there's even a possibility to explore that as possible avenue.

Mike Drues:      I think that's an intriguing question, Jon, and you know, one of the things, not to be arrogant by any means, but one of the things I do pride myself on is thinking outside the regulatory box. And doing things that nobody else has done before; doing them for the first time. So that's something that we can think about and perhaps we'll talk about it in a different discussion in the future.

                        So let's move on to the subject of today's topic, and that's the abbreviate 510(k). So like the other two types of 510(k)'s that I already talked about, we still need to show substantial equivalence, but the crux of the abbreviated 510(k) is we don't show substantial equivalence to another device, either one of our existing devices, or a competitor's device.

                        Instead, we show substantial equivalence to a recognized standard, or perhaps a guidance document, or a special control. This is often times what I refer to a "paper comparison", because you're not doing head-to-head testing. Your not testing your competitor's device, and your device using the same methodology, and then comparing the data, comparing the results.

                        It's just simply a "paper comparison", and when you do this you essentially demonstrate this Substantial Equivalence to a recognized standard using what's called a Declaration of Conformity, which is nothing more than a fancy-schmancy legal way of saying that our device conforms to or meets this recognized standard, this guidance, this special control, what have you.

                        I don't want to get too much into the details, but FDA did put out a guidance on the use of consensus standards about a decade ago, back in 2007. Happy to provide a link to that guidance for your audience as part of this podcast. And, one other thing to note about the abbreviate 510(k) when it comes to demonstrating Substantial Equivalence to the recognized standard, you the manufacturer, do not have to do it yourself.

                        You can hire a third party. This is not to be confused with third party review. That's something completely different, but you hire a third party to do that Substantial Equivalence comparison, that paper comparison for you, and issue a Declaration of Conformity on your behalf.

                        But to be fair, that's not unique to the abbreviated 510(k). Any company, if they wanted to, the could sub out part or all of their Substantial Equivalence testing to any third party that they want, to do it in a traditional or even in a special 501(k). But in the abbreviated 510(k), FDA clearly spells that out as an option.

Jon Speer:        Yeah, that's interesting, and I guess, right away what I'm starting to think about is "Okay, yeah, it seems like the abbreviated, I don't need to compare to a predicate, per se, I can leverage a census standard, a Declaration of Conformity so to speak".

                        I'm right away curious as to learn more about these consensus standards and this guidance that you mentioned. So folks we will share a link to that standard. It's certainly that you'd want to check out, because there are some standards that may apply to your product, and may make the path a little bit less nebulous, so to speak, as far as 510(k)'s are concerned.

                        This abbreviated path might be something that is of interest in your organization. But interestingly, and we've been talking about this before the podcast, there are some interesting statistics about how often each of these 510(k) methods are used, And I guess I was a little surprised that, boy, that abbreviated doesn't get much love, does it?

Mike Drues:      That's correct, Jon. In doing a little preparation for today's discussion, I did take a look at the most currently available statistics from the MDUFA Performance Report. This is as of November 2017, what's the most currently available. So for the first 10 months of fiscal year 2017, of the almost 3,400 510(k)'s that were cleared, about 82% of them were cleared via the traditional 510(k). About 13% were cleared via the special 510(k). And that number has dropped because the number that I usually quote to people is about 22% of the special, so now we have fewer companies doing specials.

                        Which, by the way, and this could be the topic of another discussion, Jon, the explanation for why the number of special 510(k)'s has dropped, in my opinion, is a bit deceptive. Some people might conclude that that means that medical device companies are making fewer changes to existing medical devices.

                        I don't think that's true. I think in reality what's happening is we have even more changes that are being managed via the letter-to-file process, and not notifying the FDA via a special 510(k). But I want to be clear, that's just my hypothesis. I have no data to back that up because unfortunately it's absolutely impossible to measure the number of letter-to-file's that are done because nobody reports them.

                        Anyway, I just thought that was kinda interesting. The abbreviate 510(k), which is what we're talking about today, is only used about 2% of the time. So, a very, very, small number of the overall 510(k)'s are brought to the market as an abbreviate 510(k), but that should not mean much to this audience, Jon, because just because something is not very commonly used doesn't mean that it doesn't have significant advantages.

Jon Speer:        Yeah, and I guess I'm a little curious, and again, probably a statistic that would be really hard to gather data to try to analyze, but I wonder ... the FDA came out with its revised guidance document, when to submit a 510(k). I think they formalized those last year if I recall, but I wonder if those had any bearing on that shift in the special 510(k). I don't know, it's an interesting question. One that may not have an obvious answer, but ... you know, I think, when I hear the term "abbreviated" ... automatically I'm looking for an edge as a med device company.

                        I am looking for that fast-track, and sometimes you hear the horror story of 510(k)s and you've shared statistics before, something like Dave, and give shared statistics before. Something like three out of four 510(k)s get rejected and all that sort thing, you know, as far as the overall industry is concerned.

                        But I hear the term Abbreviated, and I think, oh wow, that sounds like an opportunity for a fast track. It sounds like an opportunity for me to do a little bit less work and maybe make things a little bit smoother. Yeah, it's ... is that, do you think that's accurate?

Mike Drues:      Well, that's a great question, John. I think that it is accurate in the sense that that is the connotation that many people, including many in this industry have. And that is the Abbreviated 510(k) means that it is abbreviated, that it is shorter in terms of review time, that it is less work in terms of the amount of heavy lifting that you have to do and so on.

                        Unfortunately it is simply not true. When you look at the average review times for Abbreviated 510(k)s, they are comparable to, or even greater than the review time for a Traditional 510(k).

                        So, and again, I don't want to bog down the audience in a bunch of numbers, but in terms of review times, I would take whatever the average review time is for a Traditional 510(k) in your particular product code, and I would use that number or perhaps double that number for the expected or anticipated review time for an Abbreviated 510(k).

                        The only type of 510(k) that has a shorter review time is the Special 510(k). Again, to simplify the statistics, the Special 510(k) average review time is roughly about 50% of what it is for a Traditional 510(k) within that same product code. So please notice I'm parsing my words carefully here.

Jon Speer:        Yeah, yeah.

Mike Drues:      I'm not looking at average review times for 510(k)s across the board, 'cause that's way too broad of a picture. What I'm talking about here are average review times within a particular product code. That's a much narrower slice of the universe. It's a much more apples to apples kind of a comparison.

                        And perhaps in the future, John, we can take a deeper dive into the Special 510(k) like we're doing today with the Abbreviated and talk about those issues in a little bit more detail. But for right now, when it comes to the Abbreviated 510(k), I think what the audience needs to remember is that the Abbreviated does not necessarily mean what you might think it means. It does not mean less time or less work. Really what it means is the submission itself is abbreviated, and we'll talk more about that in a moment.

Jon Speer:        Yeah. And that's probably a good transition to really better understand what goes into an Abbreviated 510(k). Obviously that word has some meaning, and just clarify that it doesn't mean less work. So what is abbreviated about an Abbreviated 510(k)? What goes into an Abbreviated 510(k)?

Mike Drues:      That's a good question, John. So overall, the format of the Abbreviated 510(k) is very similar, the content, the information is very similar to other types of 510(k)s. One might even say that the format of the Abbreviated 510(k) is substantially equivalent to the Traditional 510(k). I guess, John, you have to be a real regulatory geek to appreciate the humor in that.

Jon Speer:        I totally get, I see what you did there. That's subtle, but I like what you did there.

Mike Drues:      Thank you. But anyway, what everybody is probably familiar with, the cover sheet, the cover letter, the table of contents, the truthful and accuracy statement, high level labeling and so on, all of that is basically the same. And again, FDA has put out guidance on the content of the 510(k) and we can certainly provide that to the audience if it would be helpful.

                        The most important thing that's unique to the Abbreviated 510(k) is this whole substantial equivalence comparison to a consensus standard, or a guidance, or a special control. Just like in a Special 510(k) where the most important part, in my opinion the only important part, is the comparison to your existing device and how your change in design will not impact safety advocacy performance, dot dot dot. The most important part, and in my opinion, the only important part of an Abbreviated 510(k) is that paper comparison of your substantial equivalence to an existing standard.

                        By the way, John, not to be nitpicky, but I think you did mention earlier, and some people do think this, that in the Abbreviated 510(k) substantial equivalence is set to a predicate, is not applicable. I wouldn't quite say it that way. All forms of 510(k)s, including the Abbreviated, you have to show substantial equivalence. But as I said earlier, in the Abbreviated 510(k), you don't show substantial equivalence to a specific device. Instead you show it to a consensus standard. So that-

Jon Speer:        And in fact-

Mike Drues:      Go ahead.

Jon Speer:        If I could interject for a moment. I think as a practitioner who has put together numerous 510(k)s, you know sometimes getting substantial meaningful information about a predicate device honestly can be a real challenge, frankly. And there were times that I felt like, you know, I'm trying to make the substantial equivalence argument, I'm pulling the predicate device back to case summary, I'm looking at their marketing literature, and all those sorts of things, and I may get lucky enough to get my hands on a predicate device and maybe do some head-to-head.

                        But sometimes making that substantial equivalence argument, if you will, against an actual predicate device can be challenging. So I can where this Abbreviated approach, as an engineer, that's appealing to me.

Mike Drues:      Well, you're right, John. That certainly can be a challenge. And this is in fact why, as we'll talk about in a moment, here in the United States the FDA is encouraging people to consider this new 510(k) alternative, where we don't have to make a comparison to an existing device.

                        But here's the way I look at it, John, to be totally candid, to be totally frank, that's our problem. That's not FDA's problem. Here in the United States, the regulation is quite clear. It says that we have to compare our device to an existing device.

                         And how we do that, that's up to us. Whether we do it by obtaining our competitor's device and doing a head-to-head comparison, or doing it in some other way, that's totally up to us. But what I have seen happen, believe it or not, John, and perhaps you have as well ... I have seen companies literally walk into the FDA. They basically state to them, look, our device is substantial equivalent to the other guy's device, but because we don't have access to the other guy's device, or maybe the other guy's device is no longer on the market, we can't do the actual testing to show that it is substantial equivalent. But just kind of take our word for it. You know, we're telling you that it is. FDA could tell you go pound sand, you know, and rightfully so.

                        So again, I don't mean to be harsh, but there are ways, there are lots of ways in fact, that we can show substantial equivalence. And to be honest with you, John, I don't want the regulation to tell me how to show substantial equivalence. I'm a professional. I know what I'm doing. That's a problem that I need to take ownership of, and I need to figure out how to do it.

                        So I hear what you're saying. You know, to quote a famous politician, "I feel your pain." And by the way, this is one of the areas where the European Union, with the new NDRs that are going into effect, this is where they're taking an opposite direction to what we're doing here in the United States. They don't like the idea of people using these paper comparisons anymore, and they're encouraging people to actually do a comparison to an existing device.

                        And as a result, the people in the EU are getting very apprehensive about that, for all of the reasons that you just said. You know, what if we can't get access to their data? What if we can't get access to their device? Well, again, in my opinion that's our problem, not theirs.

Jon Speer:        Yeah. It's a [inaudible 00:23:46].

                        So talking about the Abbreviated 510(k), I mean is there anything else that goes into it that you think is meaningful or helpful for the audience?

Mike Drues:      Well, so just to conclude, in terms of the content. As I said a moment ago, what's the most important part are our conformance to the recognized standard or the guidance or special controls or what have you. But I take it a step further. I don't want to just simply show conformance. I want to also show why those particular standards are applicable to us.

                        The regulation does not require us to do that. But I as a professional biomedical engineer would always do that in an Abbreviated 510(k). Here is the consensus standard that we're going to match. And, oh, by the way before I do that, let me tell you why that's the appropriate consensus standard to use.

                        And further, take it even a step further, I don't just talk about simply the standards that I'm using. If there are other standards out there that other people might consider applicable that I'm not going to use for whatever reason, I'm also going to talk about why I'm not using those standards.

                        In other words, this goes back to the statistics that you shared earlier, John, and that is so many 510(k)s are rejected. One of the reasons why is because they document not just what they did, but they do not document why they did it, and they do not document what they didn't do and why they didn't do it.

Jon Speer:        Yeah.

Mike Drues:      Bottom line, John, my advice is very simple. I want to take away all the possible reasons that I can for FDA disagreeing with me or for saying no. I want to be very proactive, not reactive.

                        And then the last thing to remember is in terms of the who's doing the testing, if you're doing the testing, or as I said earlier, if you have a third party doing the testing, that obviously needs to be specified in there as well.

Jon Speer:        Yeah. And just to comment about the previous statement that you made as far as what standards apply, which ones don't, all that sort of thing, I've seen this in action before and I'm not saying this is a good practice, but I think so often regulatory professionals who are tasked with getting regulatory clearance on their products, they're not thinking for themselves.

                        So, for example, they will go ... they'll identify the product code that applies to the product regulation, and they're looking to be spoon fed. They're looking for the list of recognized standards for that particular product code, and they're following those standards blindly at times, or those [inaudible 00:26:44] blindly at times.

                        And, you know, you and I have talked many times about don't just follow blindly down this path. I mean understand what about the standard does fit your product. It's highly likely that there are parts of the statement that just don't apply to your product. Explain why. You know? And to [Mike's 00:27:09] point also explain why it does apply to your product. So just be thorough in that explanation.

Mike Drues:     I could not agree with you more, John. You know, you and I are certainly in lockstep here. So basically, you know, as John just said, don't just explain what you do, but also explain what you're not doing and why you're not doing it. I think that's very good advice.

Jon Speer:        Yeah. And you touched on it a bit, about what's happening in the EU and we mentioned in the beginning about this alternative to the 510(k) and all that sort of thing. So, you know, it's clear. I think everybody's looking for that edge. They're looking for that fast track, so to speak, or that fast path.

                        You know, maybe touch a little bit more on your [inaudible 00:27:59] view of the world and what's happening from a regulatory perspective. I mean, you talked a little bit about the EU perspective, but obviously you've done some work close within and for Health Canada, folks that are trying to get into that market.

                        You know, it feels very fluid today as what's happening from a regulatory perspective. There seems to be, at least from what I'm hearing in the industry, a lot of uncertainty about what's happening in FDA and EU and Health Canada. And it seems like it's creating a lot more obstacles and hurdles. I don't know if you have any thoughts or comments on that.

Mike Drues:     Well, I think, John, that last part, you know me fairly well now, it's a rhetorical question, because I always have thoughts and comments to share.

                        So in terms of here in the United States, this is the topic that you and I talked about in our last podcast, and so I would encourage your audience to listen to that if they're interested. That's why we're doing the follow up here to the Abbreviated. When Dr. Gottlieb, the FDA Commissioner, just this past December announced this quote, unquote, new 510(k) alternative, which is part of the new least burdensome guidance that came out in December.

                        I'm not saying that Dr. Gottlieb was wrong. I do have a lot of respect for him. He and I share similar views on a lot of things. But I do think it's a bit deceptive. I do think it's a bit of political hype. This is not an alternative to the 510(k). In other words, it's not something that you do instead of, or in lieu of, the 510(k).

                        What Dr. Gottlieb, in my opinion, was emphasizing was this Abbreviated 510(k) pathway, which as John and I have talked about basically minimizes, if not eliminate, the necessity for doing a head-to-head predicate comparison, and instead do a paper comparison. In this particular case, do a standard, or guidance, or what have you. On the other side of the pond ... and I know a lot of our audience listens from the EU ... to me, this is one of the examples of where the US ... and the EU, more specifically ... the new MDRS that are coming into effect are actually diverging, not converging. Because here in the United States, as I just said, the FDA is now encouraging companies to use this new 510(k) alternative.

                        In other words, to show substantial equivalence to a consensus standard. Whereas in the EU, [inaudible 00:30:43] as you and perhaps some of your audience know, the new MDRS, now, are strongly discouraging companies from using the paper comparisons of ... well, they don't call it substantial equivalence, but it's essentially the same thing ... and really encouraging, or some people might even call expecting, companies to do an actual, head-to-head comparison to an existing predicate device.

                        And I don't know about you, John, but I'm getting calls and emails from a lot of my customers in the EU who are generating a lot of apprehension and angst about this because they're asking me, how do they get their competitor's data, how did they get their competitor's device? I'd love to hear your thoughts on some of those concerns, John, and how we address them. But as I said earlier, I understand the concerns, but those are our problems. Those are not the regulator's problems.

Jon Speer:        Yeah, bottom line ... And it's probably at a point where we can give some lessons to be learned, and some things for the listeners to apply to the world. The first thing is you gotta do your homework, folks. What seemed like a clear path six months, maybe a year ago, you need to ... This isn't something that you do one time, as far as determining regulatory pathways, and then go through your product development efforts, and then a couple of years later come out of the ground to look around and think that it's going to be the same.

                        This is homework. This is planning. This is something that you need to revisit throughout your product development process, but also throughout your product lifecycle. Because even though you have products in the market, the world is changing, and in some places, it seems like it's getting more challenging. Others are trying to be, at least on the surface, seem to be a little bit more creative in trying to make it a faster way, or a smoother way. But anyway, bottom line, you gotta do your homework. One of the predictions that I made for 2018 is that it's going to be harder for medical device companies to get to market, and stay in market, in the EU because of the MDR, IVDR changes that are going into effect.

Mike Drues:     Well, I would agree, John. Just taking it a half a step further, look at whether you're doing business in the United States or the European Union. To me, it really doesn't matter. The content, the information, the engineering, and the biology is exactly the same. When it comes to making your comparison, whether you want to use the phrase substantial equivalence here in the United States, or not. And this they do in the EU.

                        It really doesn't matter to me. That's a matter of semantics. You have to show that your device is basically the same as the competitor's device, or you have to show that it conforms to those standards. If you're going to do the paper comparison, that's fine, but you ... And there are a litany of ways. Perhaps, John, if you want, we can do another discussion in the future on much more specific ways that we can do this comparison of substantial equivalence, especially when we do not have access to one of our competitor's products.

                        I've been involved in countless medical devices over the years where we brought it to the market, here, in the United States under the 510(k), where we did not have physical access to the device. Just a real quick example, just one I was involved with a few months ago. It was an in vitro diagnostic. We were making a substantial equivalence argument to a device that was no longer on the market. In fact, it had not been on the market for more than a decade. So it was physically impossible to get a hold of the competitor's advice ... sorry, the competitor's device, because there were just none of them around.

                        Further, there was very little information publicly available in the literature about the technical details of the device. So we had to use our imagination. We had to come up with ways, but bottom line, we did it. And we were successful in showing that it was substantially equivalent, and we were successful, ultimately, in getting the 510(k). Is it going to be more difficult to do that, as you suggest, John? Perhaps. But just because something is a little harder to do, it doesn't necessarily mean that that's the way that it shouldn't be done.

Jon Speer:        Well, yeah-

Mike Drues:     Just something to think about.

Jon Speer:        No, and I see it all the time where, sometimes, we were looking for the easiest path. It's a short-sighted thing. We look for the easiest path on the front-end, but we don't consider the long-term ramifications. You do have to think. You do have to be a little bit creative. I like what you said about using your imagination. I think, sometimes, regulatory professionals ... Using your imagination is not something a regulatory professional should do. Clearly, you gotta think for yourself.

Mike Drues:     Perhaps ...you can correct me if I'm wrong, John ... but I'm fairly familiar with what the regulation and the guidance says. I don't recall anywhere, in any regulation or guidance that I've ever read, where it says that people should think for themselves. That people should be imaginative, or creative, or that people should think outside the box. Perhaps we do need to add that to the regulation, somewhere. Not sure.

Jon Speer:        Well, by the same token, it also doesn't say you can't.

Mike Drues:     You're exactly correct. It does not say that you can't.

Jon Speer:        Alright. So, one thing that ... As you talked and shared about the abbreviated 510(k) one. One thing that really jumps out to me as a potential lesson to be learned, or an action that I can take, is I should leverage this pre-submission path to engage with FDA. I'm guessing ... I know you're a big fan of the pre-sub ... I'm guessing that you would agree with that.

Mike Drues:     I would absolutely agree with that, John. So, to wrap this up, the best advice I can give to you and your audience, in terms of lessons to be learned, or advice moving forward. And this, by the way, is not just simply applicable to the abbreviated 510(k), but this is a common theme. Or it should be a common theme across the regulatory universe. First and foremost, be aware of all of the options that you have to bring your device onto the market. In this particular case, we're talking about the 510(k), the traditional, the special, and the abbreviated.

                        Be aware of all of the different options, the advantages and the disadvantages of each, so that you can, at the end of the day, choose the most appropriate option that you have, given your circumstances, given your technology, given your business objective, given the resources that your company has, and so on. Once you're aware of those options and you have chosen the most appropriate one, then you're exactly right, John, take it to the FDA in advance. Whether you do it in the form of a pre-submission meeting or something else, I really don't care, but take it to them, and share it with them, and sell it to them in advance, long before your submission.

                        If you submit ... and this is what still, to this day, many companies do ... if your first point of contact on your medical device is your 510(k) submission, if your first point of contact with the FDA is your actual submission, you might as well just put up a red flag over your submission saying, kick this right back in my face. Don't even waste your time reading it. So, take this to the FDA and sell it to them. And, most importantly, as you and I have talked about today, as well as before, be prepared to defend. Not just what you're doing, but what you're not doing, and why. I use this metaphor frequently, John, FDA is the most important job when they're doing their job, and they don't always do their job. But when they do, their most important job is to criticize everything.

                        So, for example, we walk into the FDA and we say the sky is blue. FDA's job is to say, okay, prove it. It's our job to prove it, and this goes back to what we talked about, before, with our comparison to a standard, or to an existing device. It's not good form, in my opinion, to go into the FDA and say, well, our device is substantially equivalent to the other guy's device, but we can't prove it because we can't get our hands on it.

                        I'm sorry, that just doesn't cut it with me. And last, specifically with regard to the abbreviated 510(k), as we talked about earlier ... Also, remember that abbreviated doesn't necessarily mean what a lot of people think it means. It doesn't mean less time, necessarily. It does not mean less work, necessarily. As matter of fact, one thing I didn't mention earlier, John. When you look at the RTA guidance to refuse to accept guidance, they have checklists for all three 510(k) types.

                        It turns out that the abbreviated 510(k) checklist is actually longer than the traditional 510(k) checklist. There is some irony to be said for that. Like I said, you know, abbreviated does not necessarily mean abbreviated.

Jon Speer:        Yeah, that's a good point.

Mike Drues:     So those are some final tips for your audience, from my perspective. What am I missing, John?

Jon Speer:        I think you did a good job of covering all the major points. And, folks, throughout today's podcast, Mike mentioned that there is an FDA guidance on consensus standards that is about a decade, or so, in existence. We'll provide a link to that. We talked a little bit about what goes into a 510(k). There's plenty of information from FDA on that, like Greenlight Guru. We also have a contact piece. I'll share the link to that, as well as The Ultimate Guide to Preparing Your FDA 510(k) Submission. Lastly, the refuse to accept checklist, and that guidance, is actually a very good document to be aware of as you're preparing any type of 510(k), frankly, because it gives you some perspective of what a reviewer is going to be expecting as part of your submission. So, I highly encourage people to become familiar with that guidance, and we provide a link to that, as well.

                        As always, I want to thank my guest, Mike Drues, president of vascular sciences. Of course, as you are delving into your regulatory strategy, if you have any questions or comments, be sure to reach out to Mike, a great resource to tap into. A lot of knowledge. He works for the FDA, and Health Canada, and other regulatory bodies, as well as numerous medical device companies all over the world.

                        And lastly, I want to remind you all that Greenlight Guru is also here to help. Our eQMS software platform consists of several products that are intended to help you during the product development process. Our dual platform has workflows for design controls and risk management, which are crucial components to any sort of 510(k), or any sort of regulatory submission, as well as our growth platform for when you go to market, to help you better manage things like complaints, customer feedback, and CAPA.

                        If you're interested in learning more about Greenlight Guru, be sure to go to www.greenlight.guru and click on the blue button to learn more information. And, as always, this is your host, the founder and VP of quality and regulatory at Greenlight Guru job sphere. You have been listening to the global medical device podcast.

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