Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pertains to its Premarket Notification 510(k) process. 

Today’s guest is Mike Drues of Vascular Sciences and in this episode, Jon Speer and Mike discuss the meaning and purpose behind this new guidance. The draft version of the guidance was Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.

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Some of the highlights of the show include:

• The guidance is part of FDA’s series of transformative steps to modernize the 510(k) program and advance the review of safe and effective medical devices.
• Is it possible to have a newer, more advanced technology that’s safer and more effective, but also substantially equivalent?
• What’s special about the new version of the guidance? All 510(k) submissions should be safety and performance based.
• FDA’s new version of the guidance spins it as a sub-type of the existing Abbreviated 510(k), but limited to well-understood/established technologies.
• Gold standard for showing substantial equivalence is to test your device against a predicate device and compare results.
• The indication for use is important to define what is or is not a similar technology or product family.
• Use new 510(k) safety and performance guidance when predicate is impractical or impossible to get. Totality of evidence is used to show substantial equivalence.
• FDA tends to push 510(k) path due to familiarity over its De Novo Program that most don’t understand. Instead, a catch-up version of 510(k) should be created.

Links:

FDA Guidance - Safety and Performance Based Pathway

FDA Premarket Notification 510(k)

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Product Development Protocol (PDP)

FDA Pre-Submission Process

FDA De Novo Program

Mike Drues

Greenlight Guru

Episode quotes:

“No guidance is ever final...these are all works in progress.” Mike Drues

“This is part of what FDA announced last year as a series of transformative new steps to try to modernize the 510(k) program and to advance the review of safe and effective medical devices.” Mike Drues

“The 510(k) is under an almost constant state of attack today. FDA, to their credit, is trying to propose changes to strengthen the 510(k) program.” Mike Drues

“The indication for use will be pretty important to define what is or is not similar.” Jon Speer

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: Folks, did you see the new guidance from FDA? I know there's been a lot lately, but this one came out early February. It's called the Safety and Performance-based Pathway. It pertains to the 510(k) process. It is a little bit of an expansion, if you will, on the Abbreviated 510(k). There was a draft guidance that came out from FDA back in April of 2018. So this is sort of a continuation on this particular theme about alternative pathways, leveraging that 510(k) vehicle. It's pretty interesting. Is there anything new or not, maybe that's debatable, but to go through what's in this new guidance document and why it matters to you, I have familiar voice and guest on the Global Medical Device Podcast, Mike Drues. He's the president of Vascular Sciences. So enjoy this episode of the Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is your host, founder, and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and today... Well, folks let's just say it feels like every week these days there's a new press release here, a new update there, a new guidance. FDA is very active these days, and I think it's good. I guess we can talk a little bit about that today. But joining me is Mike Drues from Vascular Sciences. And Mike, we're gonna dive into this new Safety and Performance-based 510(k) today. What do you think?

Mike Drues: I think that's a great topic Jon. And thanks, as always, for the opportunity to have this conversation.

Jon Speer: Alright. So you and I talked about this a little bit on a recent episode, and I think now that the guidance document is out and we'll talk a little bit about that, I don't wanna steal too much of the thunder for today, but we have a little bit more context of what this means. But I guess first and foremost, for those who maybe haven't been seeing all these updates and new guidances and all that sort of thing, it might be a good place to start. What is this new Safety and Performance-based 510(k) about anyway?

Mike Drues: So it's a great question, Jon. So this particular guidance that we're referring to, and we can provide a link on the website, it's the final draft of the Safety and Performance-based Pathway. It was finalized on February first. And, basically, it's an expansion of the previous draft. As a matter of fact, the title of the previous draft was Expansion of the Abbreviated 510(k): Demonstrating Substantial Equivalence Through Performance Criteria. That was put out in 2018 and it was just finalized in the beginning of February in 2019. And you're right, Jon, we discussed this topic in a previous podcast back in January of 2018, when Scott Gottlieb, the soon to be former FDA Commissioner, announced what he was calling the Alternative 510(k). And, by the way, if anybody thinks that this particular guidance is final, even though it's marked final, please give me some of whatever it is that you're smoking because no guidance is ever final, regardless of whether it says draft or final. These are all works in progress.

Jon Speer: Oh well, that's pretty clear. Like you said, the previous version of this, although it was titled something else, the ink was still... I guess we don't... I just realized as I was starting to say that, the ink is still dry, we probably don't even use that saying anymore. But anyway, I don't know what the software equivalent of... Digital equivalent of that is, but the previous guidance wasn't even a year old. And so now here we've already seen an iteration of that.

Mike Drues: That's right. And I think to put this in a slightly broader context, Jon, this is part of what FDA announced last year as a series of transformative new steps to try to modernize the 510(k) program and to advance the review of safe and effective medical devices. This was announced by FDA in several press releases because, as you and I have talked about and I think much of our audience knows, the 510(k) is under an almost constant state of attack today. And so basically FDA, to their credit, is trying to get ahead of the story and trying to propose changes to strengthen the 510(k) program. Overall, it's difficult. We do try to provide a bit of a balance. On one hand, we wanna try to encourage newer and more advanced technologies, medical device technologies, to come on to the market, that are safer and more effective. But at the same time we have to show that they're substantially equivalent. So my question to you Jon is, is that even possible? Is it possible to have a newer, more advanced technology that's safer and more effective, but at the same time is substantially equivalent, or basically the same as, what we already have. Or is this just simply a game that we're playing? What do you think Jon?

Jon Speer: Well, I don't know. I don't know that I feel that it's that... I don't think it's a game, I think... I don't know. It's a tough... You ask me a challenging question late in the day, Mike, and I already told you before we started that I feel like my brain is a little bit fried. But at the same time it's like... Alright, I don't feel like it's a game because I still, as a medical device company, I still have to build my case. I have to demonstrate that this product is... That I've done the proper things from not only from a due diligence standpoint, but from a product development standpoint, from a testing standpoint.

Jon Speer: Some may even argue that the whole predicate, being able to compare to a predicate technology, as you pointed out, the 510(k) process has been scrutinized by many for a long time. I, in fact, just saw a new article, I think yesterday, where some local news channel was featuring this as their top story on their evening news, and that sort of thing. So it still comes under fire. It's been under probably since the day that it came out. So I actually am encouraged by this because it's still using the premise, or the idea behind the 510(k) process, as far as building the case to demonstrate that your product is safe, and that it meets the needs of the end user, and that you've done all of the proper testing and due diligence. So I think that that's a good practice, it's a good scientific method, regardless of whether or not the predicate is involved or not. So what do you think?

Mike Drues: Well, listen, the 510(k) is here to say, there's no question about it, it's been around for over 40 years, and it's not going to go anywhere. So let's drill into, in a little more detail, this specific new version of the 510(k), which is the subject of this particular guidance, and the title of which is called Safety and Performance-based 510(k). Starting out with the name, Safety and Performance-based. Well, I don't know about you, John, but shouldn't all submissions be Safety and Performance-based? So what's special about this particular version of the 510(k)? FDA is spinning it as a subtype of the existing abbreviated 510(k). One of the differences is that it's being limited to what FDA is calling "well-understood technologies." Well-understood technologies. Well, once again, I ask the question, should not all 510(k) s, if they're substantially equivalent, should they not be well-understood technologies? And if they are not well-understood technologies, then why would they be a 510(k)? And I'll share with you some regulatory precedent on this, Jon. There's a very uncommonly-used pathway to market for Class III medical devices called the Product Development Protocol or PDP. One of the criteria of using a PDP is that you have to show that it's well-established technology. So that phrase has been around in the regulatory vernacular for quite a long time. But the regulation does not define what well-established means.

Mike Drues: And a few years ago, I had somebody come up to me, they said they were considering using the PDP, the regulation says "Well, it has to be a well-established technology. What does that mean, how do they show that?" And I said, "With all due respect, didn't you go to elementary school? I mean, do we need regulation to tell us what well-established technology means?" To me, well-established means that the technology has been around for a long time, that there's a long history of safety and efficacy, there's a good understanding of the risk benefit, we have multiple devices that have been on the market using that established technology, maybe devices from different manufacturers using similar technology. So basically, we go into the FDA, and I will do this exactly the same with this new Safety and Performance-based 510(k). I would say, "Look, the device is well-established technology and here are all of the reasons why it's well-established." Does that make sense, Jon?

Jon Speer: It does. And let me say what I heard you offer. Even with this new safety and performance 510(k), I mean, to your point, the term "safety and performance," that should be the basis of any 510(k), regardless of if I fall under the scope of this new guidance or not, I should be focusing on the safety of my device, I should be focusing on whether or not my device works. I mean, you all know by now... I'm sure if you've listened to anything on the Global Medical Device Podcast or read any content on the Greenlight through the blog, I'm a design control nerd. And safety and performance is, in my way of looking at it, another way of saying, "I'm doing a good job during the design and development process. I'm documenting good design controls, I'm capturing risk and assessing and mitigating risk to acceptable levels." So I think that is really important regardless of whether or not a predicate is involved. I still should be showing that my device is safe, I should be showing that it performs as expected.

Mike Drues: I agree. So one of the theoretical advantages of this Safety and Performance-based 510(k) is that, or theoretical requirements rather, is that the technology needs to be well established and it's up to to us to show how that is. Another of the advantages that the FDA is touting is that like the abbreviated 510(k), we don't have to do a head-to-head substantial equivalence comparison. In other words, the regulation for all 510(k) s says that we have to show the device is substantially equivalent to a predicate. But the regulation does not say how we show it's substantially equivalent. And in my opinion, Jon, that should be up to us.

Mike Drues: The most traditional way to do it, and I've done this many times before, and I'm sure you have as well, you test your particular device and a predicate device head-to-head, so to speak, and you compare the results. And that's the gold standard for showing substantial equivalent. So for example, if you have a catheter, you might have a torture track that you subject your new catheter and a predicate catheter to. And you measure such things as torquability and pushability and so on as you go through this torture track, this anatomical model. And then you do this head-to-head comparison. That's one way, probably the most common way, to show substantial equivalence.

Mike Drues: But it's not the only way, another way to show substantial equivalence is to do what I call a paper-based substantial equivalence comparison, where instead of doing the physical testing on your device in the predicate, you do a paper analysis. And this is something that we can do with the abbreviated 510(k). And now, something that we can do with the Safety and Performance-based 510(k). We compare on paper our new catheter to either an existing catheter or in this particular case, we would compare it to a generic catheter, so to speak, because another thing that's similar in this new 510(k) to the abbreviated 510(k), is that we're comparing it to a family of devices, a composite of similar devices that are either described in a guidance document, or some sort of a industry standard, or special controls.

Mike Drues: In other words, one of the criteria for the Safety and Performance-based 510(k) is to show conformity with performance criteria. So basically what that means is we're doing a paper comparison, that's point number one, but we're also not doing it to another specific device necessarily, but rather a family of similar devices. We're averaging them all out together. But let me be clear, Jon, these have always been options in all 510(k) s. In other words, I have had several traditional 510(k) s where I've done a paper substantial equivalence argument, and we can talk about when to do that in a moment. But does that make sense? Do you think that we're explaining this clearly?

Jon Speer: I think so. And I have a couple of questions to help clarify maybe some things on the topic to make sure that those listening are following along with us. But folks I wanna remind you I'm talking with Mike Drues. Mike is the president of Vascular Sciences and he's the best, frankly, when it comes to regulatory strategy and guidance. So if you have a new device or an existing device or you're making changes or whatever the case may be and you're trying to figure out the best pathway for your product and your technology, I would encourage you to reach out to Mike Drues with Vascular Sciences. We're talking about this new guidance document that came out about a month ago, early February-ish, from FDA. The Safety and Performance-based Pathway or the Safety and Performance-based 510(k). We're still talking a little bit about that, but let's dive into, Mike, a little bit about the similar technology. The word similar is one of those fuzzy gray words that would, depending on your way of looking at it could be a detriment or it could be an advantage I suppose. But you talked about the notion of similar product family or similar technology or similar, in your example, catheter, I assumed that the indication for use will be pretty important to define what is or is not similar. Would you agree with that statement?

Mike Drues: 100% Jon, as a matter of fact, that goes back to when the 510(k) was created in 1976. So really, nothing is new here when it comes to substantial equivalence. When we talk about substantial equivalence, what we mean is the two devices need to be basically the same in terms of labeling, which is what you just asked about, and technology. We have to address both of those. And when I make a substantial equivalence argument in either a pre-sub or in a 510(k) submission, Jon, I decoupled the two. In other words, many people, they will talk about substantial equivalence for labeling and technology all together. I think it's one of the reasons why, quite frankly, so many 510(k) s are rejected because of substantial equivalents. So, I'd decouple of them. I say, "Okay, here's the labeling for my predicate and here's the labeling for my device. Here's the technology for my predicate and here's the technology for my device." And I do a comparison between the two. So nothing along those lines has changed. The only thing that has changed a little bit with this Safety and Performance-based 510(k), is that we're able to do it on paper, which again we've been able to do all the time. And we're comparing it to a group and an aggregate of devices. And when I say comparing it to an industry standard, that's exactly what I mean. Because that industry standard typically is derived from a group of similar devices, how they perform. That's how we put that standard together.

Jon Speer: Okay. So let me, I know it may sound like the same question phrased in a slightly different way, but I think it's important to get clarity around this. Do you think that, with that indication for use, let's stick with that catheter example for a moment. If I'm, let's say working on a catheter that's used for central venous access and I find 'a similar technology' for a catheter that's used for arterial access. Maybe it's the same material, similar dimensions and that sort of thing. One's venous, one's arterial, but the indications are different. Is that a case where I can make that same argument?

Mike Drues: Well, you could certainly try, Jon, but the question that you're asking, and again this goes back to 1976. This is a question that the medical device industry has struggled with here in the United States for the last over 40 years. And that is how different can two devices, both in terms of labeling as well as technology, and yet still be similar enough, still be close enough to be substantially equivalent. And although FDA has put out a litany of guidances over the years to try to address that question, to be honest with you, Jon, there's absolutely no answer to that question. So here is my best advice, and I do this with companies all the time. We put together the arguments as strongly as we can, showing that the device is substantially equivalent, and then we take it to the FDA and we sell it to them. Or alternatively, when we put those arguments together and we see, gee, that difference in the example that you just gave is a great one, Jon, arterial versus venous. If those differences we think are not easy to mitigate, then maybe we take it to the FDA as a de novo as opposed to as a 510(k).

Mike Drues: But this question, and I see companies struggle with this for the 30 years I've been in this business now. How different can two devices be and yet still be close enough? I'm sorry but simply put... There's no answer to that question. We have to take it as a case-by-case basis, we have to make the best decision that we can as a company, and then once we make our decision we take it to the FDA and sell it to them. The only question that remains is, when do we sell it to them? Do we sell it at the time of making the submission? Well, many companies do that, but in my opinion, that's a huge regulatory risk. Instead, as you know, Jon, I'm a huge fan of the pre-submission process. I would take it to the FDA as a pre-sub, and say, "Here's my device, this is the way that it works, this is our labeling" and so on for all of the reasons "for all of the following reasons, we were doing this as a 510(k)," or alternatively, "for all of the reasons we're doing it is a de novo." It's interesting, Jon, when I go to the FDA with either a 510(k) or a de novo, the information that I present is exactly the same, it's just a spin that's different. So if I'm doing it as a 510(k), I emphasize the similarities. If I'm doing it as a de novo, I emphasize the differences.

Jon Speer: Yeah, and I guess I was... I'm glad you brought that up because a couple of thoughts are a rattling around in my head right now. Like first and foremost, I guess I'm trying to think, okay, there's of course a new guidance that's out but... And you kinda danced around this a moment ago. But number one, what is really new? And number two, when does this guidance, when should I be using this? And I'm gonna hit you with a few questions, let's stop there. And so I guess what is new and when is a point in case, that I should really think about using this quote "new approach?"

Mike Drues: We've already talked a little bit about what's new already, what's not new. Let's move on to the second question.

Jon Speer: Yeah okay.

Mike Drues: This is a question that I'm already getting is, "When should I consider using this new Safety and Performance-based 510(k)?" So our audience has to keep in mind that up until now, we've had three types of... Three subtypes of 510(k): Traditional, special and abbreviated. Now we have a fourth sub-type, it's actually, to use FDA's verbiage, it's a sub-type of a sub type. In other words, it is a subtype, the Safety and Performance-based 510(k) is a subtype of the abbreviated 510(k), which in turn is a subtype of the 510(k). Okay, so when should we use this? Well, the recommendation here is pretty simple. If my predicate is either impractical to get or impossible to get, this would be the opportunity to use this. I'll give you a quick example, a few years ago I was involved in bringing an in-vitro diagnostic, an IVD, onto the market as a 510(k). Our predicate was no longer commercially available, the 510(k) was active, but the predicate was no longer commercially available.

Mike Drues: In other words, we could not physically get a hold of one, even if we wanted to. So it just was not physically available. So the question is, how do we show substantial equivalence to a device that we cannot get a hold of? This is when the paper substantial equivalence argument comes in. And as a matter of fact, I've... Believe it or not, Jon. I saw somebody do this, 'cause as you know I work as a consultant for the agency. I had somebody come in and they said... "Well, our device is substantially equivalent to this other device but the other device is not available.

Mike Drues: We can't get it, but just kinda take our word for it, is basically the same". FDA is gonna tell you a go pound sand. You're laughing, Jon, but it's amazing what I see happen in the real world. FDA is gonna tell you, "Go pound sand," because it's not their problem, it's our responsibility to show substantial equivalence. So in that case, we showed it on paper, we were able to get enough information from the literature, we also involved subject matter experts that had a good understanding of the predicate technology, as well as our technology, and we were able to get them to do some paper comparisons. So at the end of the day, what FDA will take into account is what the lawyers call the totality of the evidence. If all of our evidence all added together, whether it's head-to-head testing, paper comparison, subject matter experts, literature review, and so on, and so on. When the totality of the evidence is considered, if we can show that it's substantially equivalent, we have been successful. If we haven't, if we're not able to show that it's a substantially equivalent, then our alternative is the de novo, it's about us as simple or as complicated as that, Jon.

Jon Speer: Alright well...

Mike Drues: Does that makes sense?

Jon Speer: It does and I'm glad you mentioned de novo... So some of the other things that have been happening, from an FDA perspective, is there's been some updates recently on de novo side of things as well. And I guess I'm curious, it seems like there's been a lot of, I don't know, pressure is the right word, but maybe it is the right word, so we'll use pressure, on the whole 510(k) path. And you alluded to some of that a moment ago. But we've seen a lot of iterations or are a lot of updates on the 510(k) side of things, a little bit on the de novo side of things, but it seems like, I guess, why isn't FDA pushing more de novos? Why are they still pushing the 510(k)?

Mike Drues: Well, that's a great question, Jon. And in my opinion, part of it is because of industry. People are inherently afraid of what they don't understand or what they don't have a lot of experience with, and for better or for worse, they're... The 510(k) has been the workhorse of the medical device industry here in the United States, so that's where people are most familiar with. In terms of the de novo, and as you know from our past conversations Jon, I've got a tremendous amount of de novo experience. I can tell you this, that because of all of the bad press around the 510(k), it is much easier for me to sell a de novo at the agency right now than it is for 510(k). And I also think that there's a certain degree of PR value because de novos are supposed to be for new and novel devices, whereas 510(k) s are supposed to be for me toos... So it's easier for the politicians to tout that they're encouraging new innovation if they can say that we've had an increase in de novos. As a matter of fact, I've even go so far as to say that because of...

Mike Drues: The negative pressure on the 510(k), we are going to be seeing more de novos in the future. The FDA is taking a more literal interpretation of the risk regulation when it comes to 510Ks and maybe this is a topic that we can drill into in more detail, in a future conversation, Jon, but I've got first-hand experience of devices that I thought were legitimate 510Ks that FDA is pushing strongly back on wanting the company to do a de novo because they're taking a more literal interpretation of the risk requirements when it comes to 510(k). I'm not saying that's a good thing or bad thing. What I am saying is that it is highly inconsistent with the agency's interpretation of exactly the same regulation over the last 40 years. Because let's be honest, Jon, we've got...

Mike Drues: And I use this example as FDA in one of my pre-sub meetings when I got so frustrated with the conversation. We have MRI machines that have come on to the market as a 510(k), making a substantial equivalence argument to a CT scanner. Now, it doesn't take a PhD in biomedical engineering to appreciate that gee, one system is involving magnetism, the other system is involving x-ray, that's a difference in the technology and clearly there are additional risks that are associated, and yet, it was still 510(k)-able. Those kinds of things in the past have happened with tremendous frequency. Today, it's becoming more difficult to do. That's a bit of a tangent, maybe we can talk about that in a different conversation, but... But anyway, that's my quick response to your question on that one.

Jon Speer: Okay. So folks, again, I wanna remind you we're talking about this new safety and performance 510(k). Safety and performance as you've heard Mike and I chat about on this episode already, is part and parcel to any medical device product development. Design controls risk, that's key and I would encourage you, if you're struggling with that or you wanna learn about a simpler... Frankly, a better way to manage that information, well, you should reach out to us at Greenlight Guru. We built an eQMS software platform complete with workflows for helping you better manage design controls and risk, and we've come up with this brand new refreshing approach from a design review perspective that's gonna make your life so much easier as a medical device product development professional as well. So be sure to go over to www.greenlight.guru to learn more about that. So, Mike we've kinda covered that there's not really anything new here, that some of the things that are stated in this guidance is... They've been in practice for quite some time by many regulatory professionals. I guess it begs a question. Is there a type of 510(k) that we really do need that we don't have in your opinion?

Mike Drues: Well, it's funny you mentioned that, Jon. Yes, in fact, I really do. If FDA is really interested in improving the 510(k) and creating a new version of the 510(k), one thing that we really need, and perhaps this is also something that we can talk about in a future conversation, is what some people refer to as a "catch-up" 510. And this is to address a problem many in your audience know "credit creep". Well, there's a similar phenomenon called "change creep". And that is, a medical device company gets the device on the market, they make a small change to it, it's not a significant enough change that they need to notify FDA, so they do it as a letter to file. Then they make another small change. Once again, they don't notify FDA because it's a small change, they do it as a letter to file. They make a third change, small change. They do it as a letter to file, don't notify FDA. Well, you see where I'm going with this, Jon. Each of these small changes, incrementally, is not very significant and you can justify doing it as a letter to file, but after a series of these changes when you add them all up, now, it's the philosophical question, how many changes, how different can you make...

Mike Drues: How many changes can you make in a medical device before you have a new or a different medical device? We have no formal way of bringing that kind of information to the FDA in a prophylactic way. Most of the time when companies have to deal with this, as you know, Jon, they get a inspection, they get a warning letter, a Form 483, because they've made changes to the device and they haven't notified FDA. I've suggested many times that we need something like a "catch-up" 510(k). I would also like to have a category of a pre-sub where we can do the same thing. We go into the agency and we say, "Hey, it's been a while since we talked to you about our last device. As a matter of professional courtesy we wanna update you as to the series of changes that we've made to it." The way that I deal with that pragmatically, Jon, because unlike a lot of people, I refuse to use regulation as an excuse to hold me back. I'm not going to say well, FDA doesn't have a mechanism to make this work, therefore, I can't do it.

Mike Drues: That's a convenient excuse, that's a cop out. So here's what I suggest to companies. We take all of these changes and we package them up into a Special 510(k). A Special 510(k) has been around for 20 years. The most common reason why we use it is to notify FDA of a change, so we identify the most significant change, we submit it as a Special 510(k), and embedded in that Special 510(k), we also include the other changes that we have made, along with all of the supporting documentation, the testing and so on to show that the change does not introduce new questions of safety and efficacy, it's not a change in the high-level labeling, the indications or anything like that.

Mike Drues: Now, some companies that I suggest that to, Jon, they don't want to do that, because they are afraid that if they notify FDA I have a change that's gonna open up a pandora's box and now they're gonna have all kinds of problems. And as long as they have the documentation in place, I'm not worried about that. The question to the... That I have to the company is, "Do you wanna be proactive or do you wanna be reactive?" Do you wanna go to the FDA and say, "Here are all the changes that we've made and here's all our testing to support 'em" or do you not wanna tell the FDA can have that inspection or have somebody come knocking on your door, "It's the FDA. Hey, you seem to be... Have made a change to this medical device. We don't remember you ever telling us about that in the past. What the heck is going on here?" I think we need a mechanism that we can proactively take that to the FDA without having problems to deal with first. What do you think of that idea Jon?

Jon Speer: You and I had the pleasure of talking about this very topic, I guess it was probably about a year ago, at an event. I think there's a video recording of you and I chatting about changes that, if I can locate that, I'll include that, but I think it goes into much more depth on that particular topic. But I agree, it's a tricky thing. And to go a little bit deeper on that, I think sometimes people think... "Oh, letter to file, document a memo put it in the file," but a letter to file, to borrow something that I've heard you say many times that I agree with 100%, a letter to file doesn't mean that that's a shortcut for the work, the effort, the due diligence that you have to do to be able to demonstrate that the change you're making is still safe and effective. You still need to go through the prudent engineering to be able to demonstrate that, even if the ultimate path is not a new 510(k) and ultimately results in some letter to file, it's not a short cut to the work. I guess, my thinking about wrapping up on today's session, we've covered a lot of ground. I think a lot of this is sort of a review or refresher on different points in tidbits of general 510Ks, but what do you think are some key takeaways for folks on the Safety and Performance-based 510(k)?

Mike Drues: So just to wrap this up, Jon, I think the key takeaways are as follows: First of all, in my professional opinion, not just as a regulatory consultant, but as a biomedical engineer, I would characterize the Safety and Performance-based 510(k) as being substantially equivalent to the abbreviated 510(k). And pun is 100% intended here, I see it to be substantially equivalent. Yes, there are some very, very minor differences between the two, but in reality, I don't think there are significant differences. The question is, are more companies going to be utilizing this new Safety and Performance-based 510(k)? Well, it was just created, so time will tell. But here's my thinking on it, I did some quick calculations based on the MDUFA statistics for 2018, Jon, and of the approximately 35000 510Ks that went through the agency last calender year, only about 2.5% of them were the abbreviated 510(k).

Mike Drues: And so if the Safety and Performance-based 510(k) is a sub-type of the abbreviated 510(k), which is exactly how FDA is spinning it, and the abbreviated 510(k) is only used about 2.5% of the time. I'm not sure, quite frankly, that many companies are gonna be keen on this particular tool. In other words, I don't see that it really solves that many problems that we can't solve using one of the existing tools. But most importantly, if our audience doesn't remember anything else, they should remember this, when it comes to this new Safety and Performance-based 510(k), it allows us to do this paper-based substantial equivalence argument as opposed to a head-to-head substantial equivalence comparison especially in situations where, as we talked about before, Jon, getting a physical critical predicate device is either impractical or in some cases even impossible.

Mike Drues: So those are the situations when I would consider using it. Obviously, time will tell, but my standard advice is, when you're planning on doing any kind of a 510(k), whether it's this new Safety and Performance-based 510(k) or some other type, take it to the agency in advance in the form of a pre-sub and say, "Hey, here's our device, this is the way it works, this is what it does, for all of the following reasons we're going to bring it on to the market under the Safety and Performance-based 510(k)" and sell it to them. You can greatly mitigate the questions and the problems that you run into down the road by simply doing that much.

Jon Speer: Yeah, I totally agree. And that's good advice, regardless, to reiterate your point. Regardless of your pathway, that's just good sound advice for, frankly, any type of regulatory submission whether it be any variation of 510(k), or tech file or PMA, or it really doesn't matter, this is just a good solid approach. Mike, thank you so much for giving us a little bit more insights, a little bit more information about this new safety and performance pathway from a 510(k) standpoint. Again, folks, I have been talking with Mike Drues, Vascular Sciences, he is your man to talk to about progressive, innovative, creative, regulatory strategies. He is a really wonderful asset. I know I've talked to him many times, I know we've had many customers who work with him, as well. And as I mentioned before, and I'll mention once again, there's challenges for you as a product development professional for sure. Document, management, design controls risk, you gotta set up a quality management system. These all are things that, I'll admit, most people don't look forward to, but you can look at them as a necessary evil, I suppose.

Mike Drues: But the way we look at it at Greenlight Guru is that this is an opportunity for you to run and operate a better, more sound business that puts emphasis on true quality, puts emphasis on improving the quality of life, that puts emphasis on what is good for the patient. I hope you consider that as you explore bringing your new products to market, and the safety and performance of those products, and, of course, if you need some help with your quality management system always go check out what we're doing at Greenlight Guru www.greenlight.guru and request more information. As always this is 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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