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Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it really new? Or has its existing program just been repackaged?

 On today’s episode, I talk to Mike Drues of Vascular Sciences to determine the correct answer and what it means for you, your company, and medical device.

 

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Some of the highlights of the show include:

  • FDA has 161 guidances now related to 510(k)s. Instead of more guidance, the solution should be to get people to think about and use 510(k) correctly.

  • What’s new, if anything? There’s less focus on a change to high-level labeling, intended use, and technology; but more focus on testing to evaluate the change.

  • New guidance also emphasizes risk management and quality/design controls.

  • Pilot program guidance seems vague and ambiguous - use that to your advantage. Understand its intent: Simplify the process to improve efficiency.

  • Does a Special 510(k) apply to your device? What is the criteria?

  • If making a change to a device, is testing and notification always necessary? No, but you need to demonstrate and analyze the change.

  • Change management is an issue and done poorly by most in the industry. Most companies want to take the path of least resistance and avoid the FDA.

  • Under the new program, you submit a Special 510(k), and FDA reviews it. But a mechanism is needed where people can go to the FDA beforehand to discuss it.

 

Links:

FDA Announces Special 510(k) Program Pilot

510(k) Program Pilots

The Special 510(k) Program

Mike Drues

Medical Devices - FDA

PMA Approvals

Best Practices for Medical Device Change Management

Webinar - Special 510(k) Program Pilot

Greenlight Guru

 

Quotes:

“The 510(k) has been around for a very long time, and yet so many people are still trying to figure this out.” - Mike Drues

“Are more guidances the solution to the problem?” - Mike Drues

“The 510(k) is the workhorse of the medical device industry. A lot of companies use it, but in my opinion, most people don’t use it very well.” - 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: Alright. So supposedly, there is now a new Special 510(k) program from the FDA. Is it new? Is it repackaging of the existing Special 510(k) process? Well, one way to find out, tune in to this episode of The Global Medical Device podcast, where Mike Drues from Vascular Sciences, and I, talk about this new Special 510(k) program.

Jon Speer: Hello, and welcome to the Global Medical Device podcast. This is your host, and founder, and VP of Quality and Regulatory at Greenlight guru, Jon Speer. And today I've got my good friend and frequent guest on the Global Medical Device podcast, Mike Drues from Vascular Sciences. Mike, good morning.

Mike Drues: Good morning, Jon. Thanks for the opportunity to talk to you and your audience today.

Jon Speer: You're welcome. So in the past few days, there's been quite a few industry articles, a couple of things released from the FDA, there's apparently a new [chuckle] Special 510(k) program, and a pilot that is out there, and I thought today we could dive into that a little bit. I know I've had a chance to read through this draft guidance, and I'm quite sure you have as well. So, okay with you if we explore what this is? Is it new? What does it mean?

Mike Drues: Absolutely, Jon. Looking forward to it.

Jon Speer: Alright, so maybe a good place to start before we dive too deep, is just maybe a brief recap or an overview or review, if you will, of the different types of 510(k). Special 510(k), well, what is that? And why is it different than a normal 510(k)? So maybe if you could give some context on the different types of 510(k)s.

Mike Drues: I think that is a great place to start, Jon. And by the way, before I do that, just a quick comment. You introduce what we're talking about today as the new Special 510(k) as FDA is marketing it. But like many things, it really depends on what your definition of new is, because, as we'll talk about, I don't see a lot of new in here. But in any event, let's talk about the... For the benefit of your audience, there are three types of 510(k)s that are currently recognized under the regulation. The Traditional, the Special, and the Abbreviated. About 75% of 510(k)s submitted to the agency today are the Traditional, that's probably what most of the audience is familiar with. The Special 510(k), which is the subject of today's conversation, represents about 21% of the 510(k)s. And the most common scenario where a Special 510(k) is used is where you're making a change to an existing medical device, a device that's already on the market. That change can be either in terms of labeling or in terms of design.

Mike Drues: And then the final type of 510(k), not used very often, but it's actually one of my favorite, is the Abbreviated 510(k). Only about 4% of 510(k)s go that route. Although that number is changing a little bit with the new, what FDA is spinning as the alternative 510(k), which you and I have talked about before in a previous podcast, Jon, I think it's really nothing more than the Abbreviated 510(k). So in a nut shell, the Abbreviated 510(k) relies on a consensus standard or some existing guidance to make that change. I just thought it was interesting that the 510(k)s have been around since 1976, and I did a quick search in the guidance document database to date, there are 161 guidances that FDA has put out.

Jon Speer: [chuckle] Woah.

Mike Drues: Some having something to do with the 510(k). And actually, just a few days ago, FDA announced the new guidances that they're planning on either drafting or finalizing next year, in 2019. 10 more 510(k) guidances are planned to come out next year. So I just find it interesting that the 510(k) has been around for a very long time, and yet, so many people are still trying to figure this out.

 

Jon Speer: Right. I mean, that's... I had no idea there were so many guidances on the 510(k) topic, and plenty... Sounds like plenty more to come in the coming year. That's kind of crazy.

Mike Drues: The question is, and I'll leave this as a rhetorical question for you and your audience, Jon, are more guidances the solution to the problem? [chuckle] I'm not sure about that.

Jon Speer: Well, that's something that you and I have talked about, the more regulations in a sense, guidances, it's a form of more regulation, I suppose, but that's certainly an interesting topic. But, one, it does beg the question a little bit as to why is this... Why are there gonna be 10 more guidances on 510(k) in 2019? Which kinda leads me to the next question that's on my mind is... Alright, so there's all this press about this "new program", this New Special 510(k) program, but, Mike, come on, is there really anything that's new with this, or is this just kind of a spin?

Mike Drues: Well, that's a good question, Jon. And listen, my intent here is not to be cynical, but rather to be realistic. I do think there is not a lot new here. Maybe there's nothing new here, but we'll get to that in a second. You asked the question a moment ago, Jon, do we need all of these guidances, or why do we have all of these guidances? I think the answer, quite frankly, is very simple. Obviously, the 510(k) is the workhorse of the medical device industry, and yet... So, in other words, a lot of people, a lot of companies, use it, but in my opinion, most people do not use it very well. As a matter of fact, most people use it quite terribly. When you look at the statistics, and we've talked about this before, the number of 510(k)s that are rejected is just ridiculous. So, some people think the solution is to create more guidance. I'm not sure, I think the solution is to get people to think.

Mike Drues: And specifically, with regard to this particular guidance, the Special 510(k) guidance that just came out in draft form, just wanted to let your audience know that according to FDA's plan for 2019, this guidance is supposed to be finalized in next year, in 2019. But I just wanna remind everybody in the audience that there is no such thing as a final guidance. I've said to FDA so many times over the years, we should not use the term "draft" or "final" with respect to guidance, because those terms are totally meaningless. I guarantee there will be another guidance along these lines sometimes after the quote unquote, "final guidance". So, please don't fall into that trap, I see a lot of companies do that. So anyway, back to your last question of what...

Jon Speer: Yeah, what's new? Is there something new here?

Mike Drues: Yeah, so let's basically talk about what this guidance does. So the one thing that is sort of new is that there is less focus on the change that you're making to the high level labeling, the intended use, or the fundamental scientific technology, and there's much more focus on the type of testing that you need to do in order to evaluate the change. And that, I think, is a good thing. So, is that new? Well, like I said earlier, it kinda depends on what your definition of new is. Perhaps it's new to the FDA, perhaps it's new to many people in this industry, but it's absolutely not new to me. It has been my approach from the very beginning to focus on, "How do you determine? How do you measure?" Whether it's bench top testing, whether it's subject matter experts, whether it's literature information, there's a litany of different ways, but how do you establish that that change that you're making to your device does not change the safety, efficacy performance, and so on, of the existing device? So in that regard, there's really nothing new here.

Jon Speer: Right. Mike, I was just gonna add, that one of the things that are new from a language standpoint in a guidance document, at least from my perspective, specifically around 510(k)s, again not new, shouldn't be new to you, or me, or any other of us in the industry, but it seemed like there was a lot more emphasis and specific language around things like design controls, and risk management, that frankly, I don't know that I've seen a great deal in 510(k) guidances before. So, did you find that interesting? What are your... Do you have any thoughts about that?

Mike Drues: Yeah, I did find that kind of interesting, Jon. You're right, it's never been spelled out, at least in those words, in any of the other 510(k) guidances, at least that I can recall off the top of my head. I would have to fact check that, but I think you're probably right. But again, to me, that's not new because...

Jon Speer: No, its not new.

Mike Drues: Risk management, that's... As an engineer, that's a no brainer. When it comes to quality and design controls, that's an interesting one, because many of the lower risk devices are not subject to quality... Having a QMS or design controls, as you and I have talked about before, that's not an excuse not to do those things. But from a regulatory perspective, you're not always required to. But yeah, that is an addition to this particular guidance that I do think is worth noting.

Jon Speer: Alright, so I know the other thing that I saw about this is... And of course there's a pilot program, and I was trying to look at... Okay, well sometimes when FDA announces a pilot program, there're certain inclusion criteria, if you will. But the details of the pilot program for me... To me anyway, of the Special 510(k) pilot program, were somewhat vague and a little bit ambiguous. I don't know if you have any insights that can make that a little bit clear, but... Any thoughts about this Special 510(k) pilot program?

Mike Drues: Well, I do Jon, but first I have to ask you the question, is vague or ambiguous regulation a surprise to you?

Jon Speer: [chuckle] No. No, it's not, and I've learned that from my good friend, Mike Drues, that use that to your advantage. So...

Mike Drues: That's exactly right. [laughter] That's exactly right.

Jon Speer: But it was that... Usually when there's a pilot program that FDA announces, there's... It's pretty clear, "Oh, as long as I do X, Y, and Z, then I can be a part of this pilot program." And I suppose there was some of that there, but it was a little bit vague for me. So I don't know if you have any tips about whether or not...

Mike Drues: Here's my understanding, not just what it says on the guidance or FDA's website, but more importantly, my understanding of the intent of this program, and the intent of this guidance, because it's not enough, in my opinion, just simply to read the words, we have to understand the intent. So first of all, this Special 510(k) pilot program that you're referring to, it's actually only one of a few of these pilot programs, and we can provide for the audience links to the various websites to get more information. But basically, it's a... I'm not sure I would, to be honest with you, Jon, consider it to be a pilot program, because FDA's criteria here now is that all Special 510(k)s that are submitted after October 1st will now automatically be part of this pilot program. So on one hand, they say that it's an optional program, on the other hand, all of the Special 510(k)s are going into it.

Mike Drues: So basically, it tries to simplify the process to improve the efficiency of the Special 510(k) process. Remember, the most common reason why a company will submit a Special 510(k), and this has not changed at all since the Special 510(k) was created about 10 years ago, is to make some sort of a change to an existing medical device, either a change in the design, a change in the labeling, and so on. So this basically, in a nutshell, what it tries to do is, it tries to improve the efficiency of that process. We can talk in a moment about whether we think it's going to do that or not. And one of the new things in the guidance that we've been referring to is FDA has included a new flowchart for companies to help evaluate whether a change should be submitted, either a Traditional 510(k) or a Special 510(k). I have mixed feelings about flowcharts in general, Jon, I don't like flowcharts very much because I can use them, I can manipulate them to get any result that I want that...

Jon Speer: You mean the decision tree type of flowchart?

Mike Drues: The decision tree, yes, exactly right.

Jon Speer: Yeah, okay.

Mike Drues: And number two, I see a lot of people, they follow a flowchart, they come to, to use your word, one decision, but it's not the decision that FDA has come to using the same flowchart. So I don't think it's necessarily the best approach, but FDA suggests that maybe manufacturers might even include that in their QMS as part of their change control process. I don't necessarily have a problem with that, but I do have a huge problem with the copy and paste mentality that so many people have today.

Jon Speer: For sure.

Mike Drues: And so, if you're going to do that, I think you need to personalize that flowchart, you need to add more specific criteria in there based on your particular devices, based on your particular technologies, so you can use that flowchart the way it's really intended to be used.

Jon Speer: Yeah, and folks, the guidance document, to Mike's other point, yes, we'll provide links to all of these articles and the quote, "Special 510(k) program pilot", and as well as the draft guidance. But in that guidance document, there are... This is a fairly simple decision tree flowchart, it's way simpler than the previous decision tree flowcharts like from FDA, like deciding when to submit a 510(k) for a change to a device. That flowchart is... Well, it's crazy, it goes on to one page and off to another page, and that one gets a little bit tricky, but this one's pretty simple, in my opinion. There are just a few key questions that... Yeah.

Mike Drues: It is simple, Jon. I'm sorry to interrupt, I just wanna make a quick comment. It is simple, you're right, but think about it this way, as our technologies become more complex, as our devices become more complex, should our flowcharts and our thinking become simpler? I'll leave that as a rhetorical question, but something think about.

Jon Speer: To blow my mind. Yeah, so...

Jon Speer: But the first question, I think, is important about "Does this Special 510(k) program, does it apply to you?", the first question to consider, "Is this your device?" That's probably a pretty important question to determine whether or not this might even... Whether or not this might even apply to you, don't you think?

Mike Drues: Well, yeah. What we're getting into now, Jon, is the criteria for the Special 510(k). How do you know if you can do a Special 510(k) or not? And the first question that FDA suggests is, "Does the device belong to you, or are you authorized to make changes to that device?" To be honest with you, Jon, I thought, "Gee, what the heck kind of a question is this? Why do we need such a trivial question?" But I suppose it might be that FDA has seen people come in with devices that belong to another company, and they say, "We wanna take this other guy's device, make a change to it, and put our device on the market, and do that as a Special 510(k), as opposed to a Traditional 510(k)." In my opinion, anybody that tried to do that would be an idiot. They shouldn't be in this business, and we shouldn't need regulation, but you're right, that is the first criteria, "Is the device that you're changing yours, or are you authorized to talk to FDA about it?"

Jon Speer: Yeah, sometimes I've learned in life that rules are there because, well, somebody tried to do it the opposite of what the rules suggest. [laughter]

Mike Drues: You're right, you're right. Personally, I have not seen it done myself, but if that's a rule, then you're probably right, people have probably tried to do that

Jon Speer: Some of the other questions that are in this guidance, as far as consideration criteria, as to whether or not Special 510(k) applies it, it's pretty basic stuff. Do I need testing to evaluate the change? Is there ever a case, and it doesn't necessarily have to be testing per se, but let me... Well, let's just keep it as this, is there ever a case where I wouldn't need testing if I'm making a change to something, a device of some sort?

Mike Drues: The short answer is, "Yes, there are." And in fact, there could be a number of situations where you don't necessarily need to do testing, at least not in a physical sense, where you create new data. Fundamentally, the Special 510(k) has not changed with regard to this guidance compared before... Compared to before. What you have to be able to do, and this is the intent of this entire regulation, is you have to be able to say to the FDA, "Here's the change that we've made to the existing device, whether it's labeling, or technology, or what have you.

Jon Speer: Yeah.

Mike Drues: Here's why we've made the change. And most importantly, here is how we demonstrate that that change does not affect the safety efficacy performance of the device." Now, it's that last point that you're asking, "How do we demonstrate that?" So one way that we can demonstrate it is by doing physical testing, that might be bench top testing, that might even be animal, or possibly even clinical testing, but there's a lot of other ways that we could demonstrate it. We could demonstrate it by information from the literature, we could demonstrate it, perhaps, through use of real world evidence, we could demonstrate it by having a bunch of subject matter experts, cardiologists who use a particular catheter come in and say, "Hey, I've used it this way, and it doesn't make any difference." There are a litany of different ways, the most important thing is we have to demonstrate it, but how we demonstrate that that change is not important, is totally up to us.

Jon Speer: Yeah, it's a good point. The thing that I think could be mis... There's the possible misapplication of this particular question, "Is testing needed?", it almost implies that if the answer is, "No", that maybe I don't have to do anything else, but that's not the intent behind this. You still need to analyze. Yeah, yeah.

Mike Drues: That's exactly right. Yes, let me clarify. So even if you don't have to do a new testing, you're exactly right, that doesn't mean that you don't have to do anything. It's up to us, meaning the company, the manufacturer, to demonstrate that whatever change that we're making doesn't matter. How we demonstrate it, again, that's totally up to us, but we do have to demonstrate it. And another question that I think a lot of people are asking about this, Jon, is, "With this new guidance, is the actual content of this Special 510(k) now somehow different?" And the answer is, "Absolutely not. This content of this Special 510(k) today is exactly the same as it was before this quote unquote, "new guidance" came out." As we talked about earlier, the focus of this guidance is on, "How do we demonstrate that change is not significant?" So, for the rhetorical question, "Is there really anything new here?", there was a French philosopher that said, "The more things change, the more they remain the same."

Jon Speer: For sure. [chuckle]

Mike Drues: That's the way I see it.

Jon Speer: Well, I did notice though, that it seems as though FDA is being more deliberate in their adoption of a design control and risk traceability matrices to be able to show how everything is connected, and did you assess the changes and the risk and the verification and validation that are incorporated with it? So it's like FDA is somewhat adopting more of a traceability matrix type of approach as far as presenting information as part of this. Do you agree to that?

Mike Drues: Yes, absolutely a 100% I agree. And I can understand how for somebody like you who is very astute in quality and design controls and risk management, how that would impress you, so to speak. But to me, that's common sense, that's basic engineering. Again.

Jon Speer: Wow, yeah.

Mike Drues: Again, not to be arrogant here, but I think any engineer who talks about making a change in a product without as part of that analysis, considering how it's going to impact risk of that product, with all due respect, is an idiot, and they probably shouldn't be in this business. [chuckle]

Jon Speer: Well, it impresses me because historically there hasn't been that sort of explicit, I'll say, terminology, or explicit guidance about doing so. But I'm a 100% in agreement with you that a traceability matrix for brand new device, or especially for a change, is important because if I'm making a change to something, I have to understand what is it impacted by that change? And it really is a guide to help me determine where are my gaps, where are my deficiencies, where are the things that I need to update and address. So folks, traceability matrix is by far in a way, it's a best practice, it's been a best practice for medical device product development, design controls, risk, and design changes, for decades now. And it's surprising to me, Mike, how many people still don't embrace traceability matrix, a simple traceability matrix, and...

Mike Drues: Well, I think you're right, and I think it comes back to what you talked about a moment ago, Jon, "Why do we have this now in the guidance?" I think you probably, and I wish I was wrong... Uh, you were wrong, but I don't think you are, I think probably there were a lot of instances where people made changes and did not do these things. And I would like to think that they teach these things in engineering school. I know back in the day they used to, but I'm not sure, maybe they don't today, people. [chuckle]

Jon Speer: Well, I don't know... I've talked to a lot of biomedical engineering professors in recent months, and I do think there is a pretty big gap in what is being taught, specifically in the areas of like QARA and Biomet programs, with what the expected industry practices are. And we're trying to do something about that at Greenlight Guru. And folks, if you have any questions whatsoever about traceability, what is it, how to do it, this is one of the things that we've designed specifically for you as a medical device professional within the Greenlight Guru eQMS software platform, and that's a workflow to manage design controls and risk management very, very simply, and it's all interconnected. So if you're curious about that at all, I would encourage you to go to www.greenlight.guru to learn more about how this software solution might be an aid to you to help you better communicate and organize information about design and development activities.

Jon Speer: And I wanna remind folks too that I'm talking with Mike Drues. Mike is with Vascular Sciences, and he and I are talking a little bit about this new quote... I'll use quotes, "New Special 510(k) program" from FDA. So Mike, I wanna think about a little bit about... If I make... The criteria... If I'm making a change to... So the product has to be my product, and we can define what "my product" means, to even be considered as part of this Special 510(k). But if I'm making a change to that, when do I need to submit a Special 510(k) for a change that I'm making versus just doing a Letter to File?

Mike Drues: Well, Jon, that is the proverbial, not million dollar question, but billion dollar question, that quite frankly, this guidance doesn't address. To be fair, the focus of this guidance is the Special 510(k), so the underlining assumption is that you are going to notify FDA via some sort of a 510(k), whether it's Special or possibly the Traditional. If the change was not significant enough that you don't need to notify FDA at all, then you probably would not be referring to this guidance. So, it's not a criticism of FDA, but when you look at that, and now what we're getting into, Jon, is the topic of change management, where when you look at guidances across the board, in my opinion, none of them go anywhere even close enough to answering the question that you just asked. And this is a topic of a completely different discussion. I know you and I have talked about this before, and I actually was fortunate to do a webinar for greenlight.guru, specifically on change management. Maybe we can include a link to that for the benefit of the audience.

Mike Drues: But let me just remind the audience of one thing, the more 483s, more warning letters, are issued by FDA to companies in the area of change management than for any other reason. It's an area that, I think, this industry does a pretty terrible job at. So that's a topic of a whole different discussion. Using the Special 510(k), and the flowchart, and the criteria, and this pilot program, and everything else. The underlining assumption of all of that, of course, is that the change is significant enough that we need to notify the FDA, and that we should not use a Letter to File. So I would back the truck up a few feet before getting into this conversation of whether a Special 510(k) is appropriate, or do you need to do a Traditional 510(k). The question that you need to ask even before all of that is, "Do you need to notify the FDA of this change to begin with?" Because if the answer to that question is, "No", and you do a Letter to File, then this whole Special versus Traditional or whatever, is a moot point.

Jon Speer: Yeah.

Mike Drues: So that's... As quickly as I can, that's my quick two bits on the change management piece.

Jon Speer: Yeah, well on that topic, you mentioned something I think is pretty important, that change management is a big issue in industry, and to your point, we as an industry are at best probably doing a poor job of change management. Do you think it's that... And so I'll ask you to speculate a little bit, do you think it's because companies are just, they're not making good decisions? Do you think it's that they're not documenting their decisions? Do you have any thoughts on why?

Mike Drues: Yes, I actually do, Jon. I have thoughts on most things.

Mike Drues: I actually do. And here as an engineer, what I call the root cause of this. It's not to say that people don't think about these things, or they aren't aware. No, no, no, I think it's quite frankly, most people in most companies, and I suppose this is human nature, they wanna take the path of least resistance. So most companies, they want to avoid the FDA if they possibly can, they want to do a Letter to File if they possibly can, because they don't have to notify, obviously, FDA. And most problematic to me, Jon, as an engineer, a lot of people, of course I'm stereotyping, there are exceptions, but a lot of people look at the Letter to File as a lower regulatory burden, if you will, than issuing or submitting a Special 510(k).

Jon Speer: Yeah, that's true.

Mike Drues: And in my professional opinion, the regulatory burden, whether you do a Letter to File, or a Special 510(k), is exactly the same. In other words, you have to do the same analysis, the same testing, the same documentation, the only thing that's different is what you do with that information. In one situation, you might just take that information and put it into a folder in your three drawer file cabinet. And again, I know I'm dating myself but...

Jon Speer: Yeah, you are. [laughter]

Mike Drues: But this is exactly why we still call it a Letter to File. In another situation, we might take exactly that same information and put it in a Special 510(k) and submit it to FDA, now it's part of this pilot program.

Jon Speer: Alright.

Mike Drues: I think that information is the same.

Jon Speer: Yeah, so said another way, I think, if I'm reading between the lines a little bit, maybe the practice, the bad practice that companies have implemented is that they look at Letter to File as doing less work, and that often times they may choose that path, and they don't have the corroborating evidence to rationalize or to support the decision that they made about doing a Letter to File versus a Special 510(k), or some other sort of submission or communication to the FDA. So folks, hear what Mike's saying, you still have to do the work, you still have to do the analysis, and for appropriate testing and so on and so forth, the Letter to File is not a quick pass. You still have to do the work.

Mike Drues: Absolutely, and as tempting as it would be, because I know you and I both do a lot of work in this area, I would suggest that we either continue this conversation with another podcast, or as I said, we can refer people to the webinar that I do on this topic. This is a topic that not only is it important because, as I said, generates a lot of warning letters, but perhaps even more important, it's a huge source of product liability when people are injured, and the company gets sued. So, it's a very important area.

Jon Speer: For sure. And folks, Mike has mentioned this webinar that he did with Greenlight Guru. So it is available on demand on the Greenlight Guru website, and we'll get a link to that too so you can easily access that very easily.

Mike Drues: I think the last thing to talk about, Jon, before we wrap this up, to get a little more pragmatic is, assuming that we do make a change to an existing medical device, assuming that we are authorized to make that change, that it's our device, assuming that the change is significant enough that we need to notify FDA, and finally, assuming that this Special 510(k), and this Special 510(k) pilot program is the way to go, what happens next? So basically, the company submits this Special 510(k), and as I said a moment ago, the content of this Special 510(k) is exactly the same as it was prior to this guidance. And one thing I should mention, Jon, to try to make this more palatable to companies to do this, because I don't wanna use regulation or FDA as an excuse to hold us back. Regrettably, Jon, there are medical device companies out there, including some of the largest medical device companies on Earth, who has made as a matter of company policy, have said to their R&D engineers, "Do not make changes or improvements in your medical devices that we cannot handle via a Letter to File." In other words, if you make too much of a change, we're gonna have to go notify FDA, and we don't wanna do that.

Mike Drues: As an engineer, Jon, that makes my blood pressure just jump through the roof, because there's no better way to stifle innovation and create disincentives for improvement than to do something like that. So a Special 510(k), here's the reason why I'm mentioning this, a Special 510(k) is... Forget about the content, forget about what FDA expects to see it, the Special 510(k) is actually much simpler than the Traditional 510(k), because the only information that's important in this Special 510(k) is the information directly related to the change. In other words, you don't have to show that the device is substantially equivalent or any of that other stuff, you just have to talk about the change, and why did you make that change? And most importantly, how do you demonstrate that the change is not significant? So the amount of heavy lifting for a Special 510(k) against the Traditional 510(k) that you did before it was good/

Mike Drues: The amount of heavy lifting for the Special 510(k) is pretty minimal. So, basically coming back to the pragmatic, so we submit the Special 510(k), FDA looks at it, and they basically say, "Yes, we agree with it that it can be a Special 510(k)," or, "No, we don't." And in that case, they would maybe recommend a Traditional 510(k). And by the way, even if FDA recommends a Traditional 510(k), if the company still feels that it is a justifiable to do a Special 510(k), you can push back. You can say, "With all due respect here, we disagree, and here are the reasons why."

Mike Drues: And according to the guidance, FDA's intention is to respond within 30 days, to make that decision within 30 days. But please notice, I, as well as FDA, are parsing their words very carefully, their intention is to respond within 30 days, that doesn't mean that they actually will. [chuckle] And I see a lot of people fall into that trap as well. But here's the problem that I have, if the intention of this whole new guidance, and this pilot program is to increase the efficiency of this process, I don't see how that's going to do that. I see what's really missing here is a mechanism where the company can go to the FDA in advance of any formal submission, Special 510(k), for example, to get even if it's an informal thing, a meeting of the minds, "Hey, do we have, based on the change that we're proposing here, do we have a reasonable chance that this would be appropriate for a Special 510(k)?" Because if a company submits a Special 510(k) and it's rejected by the FDA, and now we have to do a Traditional 510(k), that's been a colossal waste of time.

Jon Speer: For sure.

Mike Drues: So, if the idea here is to increase the efficiency, what I would suggest is we need to create a mechanism, perhaps another form of a pre-sub. And you know me, Jon, I'm a huge fan of the pre-submission process.

Jon Speer: Yeah, me too.

Mike Drues: Well, we can take this to the FDA informally and say, "Hey, here's the change that we're proposing, here's the testing that we've done to show that it doesn't impact safety efficacy performance, yada, yada, yada. Do we have a reasonable chance of having a meeting of the minds? Is it worth our time to submit a Special 510(k)?" And I would love to see maybe even a page limit. I've done a lot of work recently with the FDA Innovation Initiative, specifically for opioid addiction. And one of the interesting things about that is it had a seven page limit. So maybe we can submit to the FDA a executive summary of a few pages. If you can't argue that the change is not significant at least at a high level on seven pages, then that's another problem.

Jon Speer: Yeah, you might have your answer. You might have your answer. [chuckle]

Mike Drues: Right. So if we're really interested... I hear a lot of people talk about collaboration and so on, if we're really interested in working together, both companies as well as FDA, these are the kinds of things, these are kind of discussions, I think, we need to be having. Because at the end of the day, if you submit your Special 510(k), and FDA comes back and says, "No, this is not appropriate for a Special 510(k), then you've just wasted a ton of time, and who knows how much money.

Jon Speer: Yeah. Well, folks, hopefully this is giving you a lot more insights into the Special 510(k) in general. To Mike's earlier point, probably not anything substantially new with this new guidance or with this new pilot program, maybe a slight repackaging of things that you should have already been doing to begin with. And maybe just bringing... Maybe the intent behind this is to bring this pathway to your attention, because as Mike pointed out earlier, if you look at all the different types of 510(k)s, the Traditional is still... About 75% of 510(k)s are in that Traditional space, whereas the Special 510(k) is about 20%, 21%, something around there. So maybe this is just bringing more attention.

Jon Speer: Maybe FDA is seeing Traditional 510(k)s being submitted that could have been candidates for Special 510(k)s. Some of it is, who knows. But do pay attention to this, because especially if you have a history of devices that have already been cleared, this might be a good program or a good pathway for you to consider. But use all of the tools that are available to you, whether that be analysis of your change, and going the Letter to File route, or even a pre-submission that might be a good way to go as well. So that way, that you as a company are being as efficient as you can, rather than assuming this is gonna be a Special 510(k), only to find out that FDA doesn't agree with you. So realize that there's some strategy that you can use to your benefit.

Jon Speer: So, Mike, before we wrap things up, any last thought or two that you have with the audience?

Mike Drues: Yeah, so just a couple of the takeaway messages for the audience, Jon, and I do very much appreciate the opportunity to have this conversation. I hope that the folks in the audience have found it to be beneficial. Just a few things to take away. First of all, one of FDA's motivations for introducing this guidance and this pilot program is to increase efficiency, efficiency within the agency, as well as efficiency working between the agency and companies. I just talked a moment ago about how I think we can improve further efficiency between the company and the agency, but within the agency itself, FDA is hoping that it will tip the balance, so to speak. As you just mentioned, the vast majority of 510(k)s are the Traditional, and only about 20% are Special. It requires less resources to review a Special 510(k), obviously, it's simpler than a Traditional 510(k), and FDA is hoping that it will tip the balance in that direction.

Mike Drues: In reality, I'm not sure that's going to happen, because, yes, it could potentially draw some of the Traditional 510(k)s into the Special category, but it also might draw some of the Letter to Files into the FDA as a Special 510(k). FDA, quite frankly, has no idea whatsoever how many Letter to Files actually happen in the real world. Nobody does, because they're not submitted anywhere. But because I work with a lot of different companies, Jon, and I know you do as well, there are a heck of a lot of changes that are made in the medical device industry that the FDA is not told about. So that's one take away.

Mike Drues: Another one is, will this improve the efficiency of the process? Well, it won't if you submit a Special 510(k) and it's rejected. So we need to have a mechanism, and we can do it either within, probably with an existing pre-sub, but I would like to see a mechanism carved out specifically for this. Also, one last thing to just remind people of, we didn't really talk about it here, but in the area of change management, it's something I call change creep. Most of your audience is probably familiar with predicate creep, change creep is the same way. So, if we do a series of changes as Letters to File, at some point, even though those changes individually might not be significant, when you add them together, that could be a significant change. So there is something in the regulatory vernacular called a Catch-Up 510(k). It's not regulated... Sorry, it's not recognized in the regulation, but I see this quote unquote, "New Special 510(k)" being an opportunity to be... To take advantage of notifying FDA of previous changes that we've made to the device that maybe we didn't notify the agency.

Jon Speer: Yeah.

Mike Drues: So that's another way that we could use this particular submission type. And then finally, for anybody that is interested in, we can put a link on the website. CDRH does have a webinar coming up in November, where they're gonna talk about the Special 510(k). I suspect, and again, this is not a criticism, but I suspect that the webinar is really gonna be not much more than somebody reading the content of the guidance. That's essentially what most FDA webinars are.

Jon Speer: Yeah.

Mike Drues: But again, to be fair, FDA's job is to tell you the rules of poker, it's not their job to tell you how to win the game.

Jon Speer: Right.

Mike Drues: So what you and I are doing here, we're talking about not just the rules, but more importantly, how do we win the game?

Jon Speer: Yeah, Mike, you used poker references a few times in conversations that I've had with you. So maybe one of these days, you and I can sit down at a table, and play some Texas hold 'em or something. [laughter]

Mike Drues: I would love that, Jon.

Jon Speer: Alright, well, once again, thank you so much for taking some time to talk with our audience about the Special 510(k) program. Again, folks, I've been talking with Mike Drues. Mike is with Vascular Sciences, he's a regulatory guru, a regulatory genius, this is his chosen profession, and folks, he's damn good at it. So if you have any questions about how, and what, and when, and strategy when it comes to regulatory, you should contact Mike Drues with Vascular Sciences. And again, if you're looking to build your QMS or improve your efficiency internally, with things like managing design controls, designing history files, design changes, risk management, all the things that go along with that, I would encourage you to head on over to www.greenlight.guru, to learn more about the Greenlight Guru eQMS software platform designed specifically for and by medical device professionals. So, this has been your host, the founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast. 


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