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

January 10, 2018

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This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? 

In this episode I talk to Mike Drues, president of Vascular Sciences, to help us all understand what’s different about this fast track and how it might benefit you.


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Some highlights of this episode include:

  • What the new draft is about and how long this fast track has really been around.
  • Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office.
  • The FDA’s revised definition of “least burdensome.”
  • Why, despite increased marketing and hype, the “new” path is not really new at all.
  • What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier.
  • Some questions to ask yourself if you want to know if you are working on something new or novel.



FDA Guidance Least Burdensome Provisions Draft

New Steps to Facilitate Beneficial Medical Device Innovation - FDA

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More - RAPS

FDA medical device proposal may skirt the law: legal experts - Reuters

Mike Drues on LinkedIn

Vascular Sciences

Jon Speer on LinkedIn

Greenlight Guru


Memorable quotes from this episode:

The alternative path is being marketed as a new fast-track path... that is obviously going to capture people’s attention. But is there anything new about it?” - Mike Drues

The new path puts a greater emphasis on technical standards... it’s similar to what we’ve been accustomed to many years.” - Jon Speer

This is exactly the abbreviated 510(k). There is absolutely nothing new here.” - Mike Drues


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: Curious, if you've been reading some of these recent articles about this new fast track or this quick path to get products to market, an alternative to a 510(k), if you will, from an FDA perspective. Some interesting reading, but as you read through this, and the new FDA guides document on least burdensome approach, I want you to think about one thing: Is there anything new here? Well, good news for you, Mike Drues and I dive into this topic, on the next episode of The Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is your host, the Founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and I'm excited to have my guest, Mike Drues, President of Vascular Sciences join me today. Mike, how are you?

Mike Drues: I'm well Jon, thank you.

Jon Speer: Well, Mike I know you're a big fan of regulatory strategy and for people to think for themselves, so to speak, when it comes to regulatory as a science and that sort of thing, and it's with that spirit in mind, really, that I was hoping we could dive into some recent news I suppose. Specifically, there's been something, a few things that I've come across about a new draft guidance that FDA has around the least burdensome approach concepts and principles that came out a few weeks ago. And then also, there's been a few other articles that have come out about fast track and this sort of thing. So what do you know about this new guidance document, the Least Burdensome Provisions?

Mike Drues: Well, it's a great place to start, Jon, and thanks for the opportunity to have this conversation with you and your audience. The guidance that you're referring to coming out just last month in mid-December of 2017, entitled the Least Burdensome Provisions: Concepts and Principles, basically tries to add some clarity to this concept of least burdensome, which actually is in fact not new, but it's been around for a long time. It was officially introduced in the regulatory vernacular back in 1997, as part of the FDA Modernization Act of 1997. When you think about it, it actually goes back to 1976 when the 510(k) was created because the whole premise of the original 510(k) took advantage of the least burdensome approach. And then more recently with the 21st century Cures Act that went into effect in 2016 at the end of the Obama administration, that tried to further clarify and expand the least burdensome concept. So, this is really, I think, the reason why more people are talking about it today. And the most important reason why people are talking about it today, is because it's the natural extension of one of President Trump's campaign promises and that is to reduce regulation across the board, including FDA regulation, in order to try to allow safe and effective medical devices to get out into use as early as possible.

Jon Speer: Yeah, it's with that last point in mind, and I think you and I talked about this, and I can't remember if we actually did a podcast about it or not, but I know you and I talked about, prior to Trump taking office there was a lot of hubbub, so to speak, about whether or not... I even remember reading the title of one article that President Trump was gonna blow up the FDA, not... More in an operational standpoint. And there was a lot of press about who the next head of FDA was gonna be and that sort of thing. And now, I think the first few things that came out once Trump took office was about the impact on the pharmaceutical side of the life sciences industry. And now, from my perspective anyway, this is sort of that first formal content that we're seeing about the potential impact on med device.

Mike Drues: I think you're right, Jon. I think in that sense it is the first formal content coming out of the agency. Just a little bit of historical perspective as some in the audience may remember, in February of 2017, just a few months after President Trump came into office, he announced that specifically when it came to FDA regulation his goal was to reduce FDA's regulation by some 70-80%. And to be honest, politics aside, I think... I hear a lot of people, as I'm sure you do as well, Jon, say that we have too much regulation. Other people might say, we have too little regulation. I think that's really the wrong question that we should be asking. The amount of regulation is not important. What's much more important for me as a regulatory consultant, and as you know, and many of your audience know, Jon, I work as a consultant for the FDA as well, so I see these issues from both sides, it's not the amount of regulation that's important, it's what that regulation, actually accomplishes in the real world, because every day as a regulatory consultant, I read regulation, not just here in the United States, but around the world, that to me as a professional biomedical engineer makes absolutely no sense. And yet, people follow it anyway. And so I think that it's not the amount of regulation that's important, it's what it actually does.

Mike Drues: But let's come back to the topic of today's discussion, and that is least burdensome, and I thought one thing that would be interesting to talk a little bit about is FDA's revised definition of least burdensome, which, as I said, has been around for decades, but this was recently updated in this guidance last month. Basically what they said was, "What is the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time?" Again, I don't normally insult people's intelligence by reading a regulation or a definition to them, but because this is important let me read it one more time, and Jon, I'll ask you to kinda think about it, tell us what you think of this definition. So, FDA's definition of 'least burdensome' right out of this last guidance. "The minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time." Jon, as a regulatory and a quality guy. What do you think that means?

Jon Speer: Well, there's a lot of fuzzy words in there, 'adequately', 'most efficient'. [chuckle] And I confess, yeah, I'm an engineer, and I look for nice black and white, non-grey, non-fuzzy terms, that I can objectively as best as possible wrap my head around. But there is a lot of ambiguity there, and I suppose, if there's one thing that I've learned from Mike Drues over the years of talking to you, it's this, and I'll paraphrase, "Use that ambiguity to my advantage." I get to define what that means. And as long as I build the case to support what minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time, as long as I can build that case to my advantage, then the good for me, right?

Mike Drues: Well, I'm glad that you remember that from our many conversations, Jon.

Mike Drues: That is an important lesson to be learned, because I agree with you 100%, that is a very ambiguous definition, although to be fair, I'm not sure I could come up with a better definition.

Jon Speer: That's true.

Mike Drues: It's kinda like 'substantial equivalence'.

Jon Speer: Yeah.

Mike Drues: What the heck does 'substantial equivalence' really mean? The devil's in the details. And this... It's also important to remember this is part of a broader initiative where FDA is trying to reduce the amount of clinical evidence that's required for approvals in keeping with President Trump's vow to cut regulation. And I think this presents sort of an interesting difference between what's happening now in the United States versus in the EU.

Jon Speer: Yeah.

Mike Drues: As you know, in the EU with the new MDRs going into the effect, the EU is now expecting more clinical evidence. And yet, here on this side of the pond, in many cases, FDA is saying less clinical evidence, or perhaps to be fair, maybe less clinical evidence pre-clearance or pre-approval and more of that burden is being shifted towards once the product is on the market.


Jon Speer: Yeah, I came across a report. Boy, it's been a few weeks ago, but I did write a piece about it, 'cause it was really intriguing to me. I don't know, and it's probably a conversation for a different podcast, but there is some interest from FDA on patient reported outcomes of devices. And when I read that, it seemed to me like, I was confused, because almost the next day, I was reading all these other articles about this alternate pathway to the 510(k) and it seemed like there was a little bit of conflict happening like, "Is FDA gonna be requiring more patient data?" But at the same time I'm reading that they're looking for this alternate pathway. And, so as a practitioner, I was a bit confused, because if I need to gather more patient data, then that doesn't necessarily mean a faster path. That usually means a slower path, if I'm gonna be subjected to that. And that's where I think this conversation that you and I are having today is gonna be helpful to the audience to maybe give them a little bit of clarity on this. Because there's a lot of conflicting information that's out there. And as you noted, all the changes with the EU medical device regulations, certainly it seems as though that's gonna make it more challenging to get products to market by requiring more and more clinical data.

Mike Drues: Well, I think the topic of clinical data, and how much clinical data that you need and when you collect it, either pre or post-market, I think those are all great topics of discussion. We should definitely plan on having a future podcast specifically on that topic. But I suspect for your audience, at the moment, Jon, because of this particular guidance, maybe we should delve into this, "alternative pathway" to the 510(k). And what I think is kind of interesting is that it's being marketed... And by the way, in politics, there's just as much spin as there are in medicine. It's being marketed as a new fast track to market for certain medical devices that have a potential reduction in the amount of safety data required for approval. As a result this could save companies millions of dollars in testing and maybe take months or even years off of development times. So when we see announcements like that in the press that's obviously going to capture people's attention. But Jon, Do you think that this new, alternative pathway to the 510(k). Is there anything new about it in your view?

Jon Speer: Mike, no.

Jon Speer: In a word, no there's not. And like you said, there may be spin, but when you read headlines like, and this was one... The one that, well, caught my attention and good for the writer of the article 'cause they created a really good headline, but it said, "FDA medical device proposal may skirt the law." It was like, "Whoa wait. What's that all about?" And then you start reading and you're like, "Oh well, this isn't new." It maybe puts a little bit more emphasis on technical standards and that sort of data and information. You have to demonstrate safety rather than putting more weight on the predicate side of things, but by and large, I didn't read anything that I was like. "Oh, wow, this is revolutionary." It just seemed like it was very similar to what we've been accustomed to for many years now. What about you?

Mike Drues: And I agree with you. That was obviously a leading question, perhaps even a loaded question, but when you and I say it's not new, for the benefit of the audience, what is this exactly describing? It's an existing regulatory pathway to market; albeit a very uncommonly used pathway to market, but it is one of the types of 510(k). What is being described in this guidance here

Jon Speer: It reads to me like, very much like, what FDA already has with the abbreviated 510(k).

Mike Drues: That's exactly right, Jon. Kudos to you. You hit the nail right on the head. This is exactly the abbreviated 510(k). There is absolutely nothing new here. As I was thinking about our discussion today, I was constantly reminded of the French philosopher, I don't remember his name, but he said, "The more things change, the more they remain the same."

Mike Drues: The abbreviated 510(k)... The abbreviated 510(k), which is not used very commonly, as you probably know. Of all of the 3,000 to 5,000 510(k) s that come onto the market every year, only about 4% of them come onto the market using the abbreviated pathway. About 70% are the traditional. About 22% are the special. And the remaining 4% or so are the abbreviated. That pathway has been around for a very long time and it relies on a consensus standard. In other words, you're not showing that your device is substantially equivalent to another specific device; a predicate device. You're showing that your device is essentially substantially equivalent and I'm using the definition of 'substantially equivalent' the equivalent's a little bit loosely here. You're showing it's essentially substantially equivalent to a technology, a technological standard, a guidance document, something like that. So as I say, in some of my regulatory courses, you can accomplish, you can make an abbreviated 510(k) submission in only one sentence, if you wanted to. All you would be required to do is say, "My device conforms to this particular standard." And sign it and date it and you're done.

Mike Drues: Now of course, I would never make an abbreviated 510(k) submission that way. But that's exactly what the essence of the abbreviated 510(k) submission is. And by the way, 'cause I get this question a lot from people, Jon, abbreviated doesn't necessarily mean what a lot of people think that it means. In other words, abbreviated does not mean faster or easier or anything like that. As a matter of fact, if you look at the RTA guidance, the Refuse to Accept guidance that came out about two years ago, the abbreviated 510(k) checklist is actually longer than the traditional 510(k) checklist. So there is some irony for that.

Jon Speer: Yeah.

Mike Drues: But nonetheless what they're describing here is the abbreviated 510(k). What do you think of that Jon?

Jon Speer: Well, it's... It is a... You said it a moment ago. The spin factor seems to be a little bit at play. Industry has often talked about faster paths to market and getting things through the regulatory obstacles a little bit smoother, a little bit faster and that sort of thing. And good on FDA for reminding us of this path that's always been there that now we can take advantage of, I suppose, but... [laughter]

Mike Drues: Well, I guess on one hand... On one hand, Jon, I think it's good, that you say, it's good for FDA to remind us. On the other hand, I would like to think that, for those of us working in this industry, we don't need a reminder like that from the FDA that we understand all of our different pathways to market. And I'm being very serious about this. This would be like a surgeon not being familiar with all the different methods that they can do, to use, to accomplish a particular procedure. But I also think that this pathway also represents another area of potential regulatory divergence. Not convergence but divergence between the US and what's going on in the EU right now. Because, as you know, with the new MDR regulation going into effect across the pond, they're wanting more and more specific comparisons to specific devices, similar devices or reference devices, whatever you wanna call it. And, it seems like, at least in this particular case, for certain kinds of technologies, for certain kinds of devices, for lower risk kinds of devices, we're going away from that. So, it seems to me that there might be some differences that people are gonna have to be aware of depending on what side of the Earth they happen to be dealing with at the time.

Jon Speer: Yeah, it's true. Prior to the EU MDR going into effect, it was very possible that your product development and your regulatory strategy, they would by and large, not exactly, but by and large, be in harmony with one another or in sync with one another. And now, it definitely does seem like there's a divergence where you're gonna have to have two different strategies, maybe more, depending on where in the world that you're going to be pursuing your market opportunities. And maybe, and this is speculative here, but maybe this is FDA's way of saying, "Hey, medical device companies who wanna be innovative, remember that the most innovative opportunities that you have in the world to bring your product to market, maybe that's through FDA channels rather than other regulatory channels." I don't know. And like I said, that might be speculation.

Mike Drues: Well, I hate to say it, my friend, but I think you're starting to drink some of the Kool-Aid yourself.

Mike Drues: Let's think about this a little bit, because when we talk about innovative devices, okay, innovative technologies, okay, if there's already some sort of a guidance document, if there's already some sort of a consensus standard describing it, how innovative or new is it? I would argue that if there is already a guidance on it or a consensus standard on the technology, I'm sorry, that's not new, that's not innovative.

Mike Drues: Oftentimes I hear people saying to me they're working on this new and novel medical device, and when they describe it to me, in about 30 seconds I quickly realize, "This is really not new at all." So several years ago I developed my own little litmus test, and perhaps I've shared this with you in one of our podcasts before; I'm not sure. If you think you're working on something truly new or novel, ask yourself the following three questions: Is there regulation on it? Is there guidance on it? Is there reimbursement for it? If the answer to any of those questions is "yes," I'm sorry to burst your bubble, but you're not working on anything new or novel. Because, at least, in my book, one of the parts of the definition of 'new or novel' means that you are doing something for the first time, or at least one of the first times, and as a result there is no regulation, there is no guidance, there is no reimbursement for it. What do you think of that, Jon?

Jon Speer: Well, I feel like I just got put in my place by Mike Drues, a little bit.

Jon Speer: But, and it's a valid point.

Mike Drues: Well, that was not my intent.

Jon Speer: No, no. But it's a valid point. I guess what I was attempting to do is compare FDA-regulatory versus EU-regulatory, and I guess the more innovative of the two approaches, at least in our current landscape, certainly seems to be more of an FDA approach. But touche. This goes back to some of the other things that we've talked about, and you did a webinar for Greenlight Guru recently on the topic of de novo. Folks, if... Mike's right, if you wanna be truly innovative, then you're considering... You're probably gonna be in a space like a de novo or a PMA type of submission to bring your product to market, rather than a 510(k) abbreviated, traditional, and that sort of thing. So just keep that in mind. But it is interesting, though, as you read these articles. And folks, we'll share a lot of these with the content that accompanies the podcast. When you read it, some of the statements are really interesting that are in these articles, but as Mike and I have talked about here today, it's not really new. These are provisions that have been available to us for quite some time.

Jon Speer: And to Mike's comment a moment ago about the Refuse to Accept checklist for an abbreviated 510(k) in fact being longer and more comprehensive than a traditional 510(k), this is the message that I think we need to leave with, or make sure people understand. The burden of proof to demonstrate that your product is safe, it's still there. This is not cutting any corners or reducing the types of things that we should be doing as good product developers, as good engineers. We still have that responsibility to the patients, to the caregivers, who are gonna be using our product, to be able to demonstrate that our product is in fact safe.

Mike Drues: I agree, Jon. That's an important message, and I would just amplify that. Let me be crystal clear, let me be as pragmatic as I can. I have no problem with this alternative approach, this new approach, this abbreviated 510(k). I don't care, quite frankly, what we call it. After all, Shakespeare said, "A rose by any other name still smells as sweet." So I don't care what we call it. What I care about is how we use it. So if a medical device company is developing a device based on well-established technology, technology that's been around for a long time, technology that's used in a number of different devices, technology that is well-understood, that has a history and so on, I have no problem using these shortened, these abbreviated approaches, if you will, if you wanna make a substantial equivalence argument to a technological standard, I have no problem with that.

Mike Drues: What I do have a bit of a problem with, is there... And let's be honest, there are some companies out there that might use this an opportunity to go beyond that and to see this as just yet another loophole in the law as an excuse not to do what you and I have talked about before, Jon, makes sense from a biology and an engineering perspective. At the end of the day, this should not be an excuse for sloppy engineering. I've been a huge fan of the abbreviated 510(k) for many, many years, long before this new guidance came out, long before President Trump took office. But it needs to be used properly, and I just think that sometimes that just doesn't always happen the way that it should.

Jon Speer: Yeah, it's a really good point. And folks, like I said, we'll share a lot of the content that, essentially, and we'll share a link to the least burdensome guidance document. And feel free to form your own opinion. But Mike, any parting words to our audience before we wrap up today's conversation?

Mike Drues: Well, [chuckle] I'm surprised that you're gonna give me the opportunity, [laughter] because... No. And look, listen, as your audience who have listened to us before know I'm a huge fan of doing what makes sense. And if something makes sense to me, from a biology and an engineering perspective, I have absolutely no problem taking it to the FDA and sell it to them. As a matter of fact, I pride myself on not being the regulatory police. Let's face it, Jon, and many organizations and many companies are just... Or, sorry, many regulatory folks are just viewed as the police 'cause they're constantly telling R&D and manufacturing, other areas, what they cannot do. I do not take that approach. I say, "Here's what you can do as long as it makes sense." In some cases the testing requirements that FDA puts in place are sufficient and I have no problem meeting them. In other cases, I think the testing requirements that FDA puts into a place are overly burdensome, and in those cases, I will go to the FDA and say, "It is not necessary to do this particular kind of testing and here are all the reasons why."

Mike Drues: And yet in some cases, I think the testing requirements that are in place by FDA are not sufficient, as a professional biomedical engineer. And in those cases, I will go to the FDA and say, "In addition to what testing that you're asking us to do, we are also doing this additional testing, because this is the right thing to do from a biology and engineering perspective." So, that's my most important message to your audience Jon. That might not always make me the most popular person in the room, but as a regulatory consultant, one of my most important jobs is to ask questions that sometimes other people don't want to ask. Something to think about.

Jon Speer: Yeah, it definitely is. And folks, the key thing here is use your brain. Think for yourself.

Jon Speer: No one knows your product, your technology, at least I hope, better than you. And you have to be able... Of course, the burden of proof to demonstrate that that product is safe is absolutely something that you need to do, but don't just follow blindly. Don't just fall into the trap of assuming that, because there's this standard or this guidance or this thing over there, that you have to blindly follow that without using your own brain and your own thinking capacity and that sort of thing. So Mike's right, there's plenty of... I assume, that if you listen to all the podcasts and the webinars and the content that Mike and I have done over the years that you can do this pretty well. You can figure out a path that makes the most sense. And at the same time, reach out to Mike Drues at Vascular Sciences or you can reach out to me at Greenlight Guru. If you have any questions or comments, we're here to help you. We want you to get your new products to market as quickly as possible. And whether that means using a traditional 510(k) or an abbreviated 510(k) or a de novo path or whatever the path may be, you've got people in your corner who are here to help you with your sound regulatory strategy.

Jon Speer: And it's with that in mind that we've built the Greenlight Guru software platform. Our product has workflows to help you build that burden of proof through the design and development process, through design controls, through risk management. So, if you're interested in learning a little bit more about what we do at Greenlight Guru, I encourage you to go over to www.greenlight.guru and read about all of the things that we're doing and click the green button or the blue button, I'm sorry, to request more information and we'd be happy to have a conversation with you. As always, I thank my guest, Mike Drues, from Vascular Sciences for joining me on this conversation today. And I can assure you that we're gonna have many more exciting conversations on the Global Medical Device Podcast.



The Global Medical Device Podcast powered by Greenlight Guru is 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.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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