A Regulatory Gap Analysis of FDA's Systems & Policies

January 26, 2022

GMDP-header-Mike Drues (1)

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?

In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, analyzing gaps in FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.



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Some highlights of this episode include:

  • Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.
  • Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.
  • The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.
  • The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.
  • Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. 
  • Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device.
  • "Change creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.
  • A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. 



FDA - Corrective Action/Preventative Action (CAPA)

FDA - Overview of Device Regulation

FDA - Premarket Notification 510(k)

FDA - Premarket Approval (PMA)

FDA - General Wellness

FDA - Case for Quality

FDA - Warning Letters

FDA - Form 483 FAQ

FDA - De Novo Classification Request

FDA - Emergency Use Authorization (EUA)

FDA - Breakthrough Devices Program (BDP)

FDA - Safer Technologies Program (STeP) for Medical Devices

FDA - Custom Device Exemption (CDE)

Centers for Medicare and Medicaid Services (CMS)

Mike Drues on LinkedIn

Greenlight Guru Academy

True Quality 2022

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable quotes from mike drues:

“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”

“As we all know, the 510(k) is the workhorse of the medical device industry.”

“I’m a huge advocate of communication with the FDA.”

“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”



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: If you have been a listener or watcher of the Global Medical Device Podcast for any period of time, there's a good chance you've come across at least an episode or two where I chat with Mike Drues with Vascular Sciences. And often not always, but generally when he and I chat, we're reacting to some new guidance or some article, or something that's come out from FDA, this, that, or the other. We decided in this episode to change the perspective a little bit and instead of reacting to something, let's be a little bit proactive. And the topic that we talk about are some things that might be missing in the current FDA regulatory framework, gap analysis of sorts, if you will. We dive a little bit into that, and maybe throw out some thoughts and ideas on where there could be some opportunities for improvement. I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host and co- founder at Greenlight Guru, Jon Speer and joining me today is familiar voice and hopefully familiar face by now for those of you that have consumed the Global Medical Device Podcast episodes on YouTube. That's Mike Drues with Vascular Sciences. Mike, welcome.

Mike Drues: Thank you Jon.

Jon Speer: A lot of times, when you and I get together Mike, we talk a lot about maybe a new guidance or a new this or a new that. And I guess to descript around, a lot of times, we're reacting in some respects to things that are happening in our industry. And one of the last times that you and I chatted, we were preparing for future episodes and you threw out this idea. And I like this idea a lot actually is how can we be a little bit more proactive, maybe throw some thoughts and ideas, some context leveraging your decades of experience, my decades of experience in this industry. Maybe there's some opportunities that are missing that maybe we can help, I don't know, shape or throw some ideas out there and see if we can help shape some changes in regulatory policy. What do you think? I mean that's my take on why I'm looking forward to today's conversation. Why do you think it's a good idea to talk about things that might be missing from the regulatory framework?

Mike Drues: Yeah. Well, great question Jon and as always, thank you very much for the opportunity to have this important discussion with you and your audience. Look, one of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively to use your word, as opposed to proactively. In other words, a problem occurs and then we try to create some new regulation to prevent that problem from happening again in the future, and that's certainly an admirable goal. But on the other hand, there is a lot to be said for preventing problems before they occur. You and I on the quality side Jon have talked about CAPA, corrective action preventative action and one of my frustrations there is why the heck do we call it a CAPA, as opposed to a PACA. The emphasis should be on preventative action, as opposed to corrective action. So, that's the reason why I made this session for today's discussion because let's be honest Jon. Well, you and I included, but there's a lot of other people out there that are talking, sometimes complaining about the current regulatory environment that we live in, the current system, but there's very few discussions with people having practical tangible ideas on how to improve it, how to make the system make the world a better place, fill in the gaps as I'd like to say this gap analysis, if you will, of regulatory environment. As we continue our discussion today Jon, I'd like to make it as practical and pragmatic as possible in two ways. The first way is offering manufacturing friends ideas on how to prevent problems right now before we start to some of the changes that you and I are going to discuss today, to mitigate or avoid problems in the future. But second as you alluded to Jon, we do have a few of the regulators in the audience. I have a number of my friends at FDA that listen to our podcasts, although I'm sure they would never admit to that publicly. What I would encourage those in our audience who work in either FDA, or other regulatory agencies around the world, consider some of the ideas that Jon and I are going to talk about today. And if they make sense, maybe bring them back to your department, to your agency and have some discussions. And maybe involve people from industry Jon or myself or other people, " Hey, this might be worth a discussion."

Jon Speer: Sure.

Mike Drues: That's the back story, that's the impetus of why I thought having this kind of a discussion would be a good thing to do, especially as we begin this new year of 2022 looking forward, as opposed to looking back.

Jon Speer: Yeah, and I know we're all at a point in time with obvious things that have been happening in the past couple years, that I think we're all looking for opportunities to look forward. We'll put the regulatory, the med device industry regulatory spin on this conversation. And maybe a good place to start and I know for probably... well certainly the past handful of years, it seems like there's been a lot of discussion or interest in like 501( k) reform, and that comes up from time to time. And every so often, you and I have chatted about the new 501( k) this or the new 501( k) that. And then when we have the discussion, turns out oh, there's nothing really new here. It's really the same old, same old, but maybe a good place to start to dive in is from your lens, your way of looking at the regulatory world in the med device industry, what is missing? I mean do we need additional mechanisms or methods or ways that we can communicate with FDA and even other regulatory bodies beyond the FDA? What do you think is missing right now?

Mike Drues: Well, first of all Jon, you mentioned" 501( k) reform," so let's start with that. Look, as we all know, the 501( k) is the workhorse of the medical device industry. Certainly here, there's no question about it, but does that mean that the 501(k) is a perfect program? Absolutely not in anybody, and I literally mean anybody who gets out there and says that the 501(k) is a perfect program, I think quite frankly is naive or just flat out stupid because regrettably, there have been devices that have been brought to the market under the 501(k) that quite frankly never should have been brought to the market under the 501(k). There needs to be adjustments to the 501( k). I have never publicly advocated going as far as the institute of medicine. A few years ago when they said throw the whole 501( k) out of the window-

Jon Speer: Oh yeah, I remember that. Yeah.

Mike Drues: ...I think that would be throwing the baby out with the bath water, but nonetheless, there needs to be improvement. I think the biggest limitation, or the biggest problem with the 501( k) in my opinion Jon is this phenomenon called predicate creep. And to try to address that, some people have talked about the so- called 10- year predicate role, which I am adamantly against. I don't think that's a good idea, but that's certainly something and maybe Jon because it is the 501( k) is the workhorse of the medical device industry. Maybe we have a separate podcast in the future, specifically getting into the good, the bad and the ugly of the 501( k) because it's a good program. No question about it, but it is by no means, a perfect program. On the 501( k) side, there's certainly room to improve there. But in addition to that, I do think you mentioned Jon maybe we need some additional mechanisms to communicate with the FDA.

Jon Speer: Yeah. Well, I think to your point because the 501( k) has been the workhorse for so long, I think so many folks try to shove stuff into that 501( k) vehicle so to speak, because it's the most familiar, it's the most common, it's the most well understood. And it is like you said the workhorse, but you and I have talked a lot about, I know you're very passionate about things like wellness devices, right? What are your thoughts about wellness devices? Are there things missing? Are there opportunities for improvement within the wellness area that we should be considering, or thinking about?

Mike Drues: Well, under the general topic of communication with the FDA because you know Jon, I'm a huge advocate of communication with the FDA, I will communicate with FDA a heck of a lot more frequently than any regulation or guidance will ever require, but sometimes, FDA does not make it easy to communicate with them, and let me give you a couple of examples.

Jon Speer: Sure.

Mike Drues: First on the wellness side. We today now in 2022 have no mechanism, certainly no formal mechanism where a company can take a device to the FDA prophylactically, if they think their device is a wellness device, to be able to explain, " Here's our device, this is what it is, this is how it works," and so on for all of the following reasons. We believe that this is a wellness device and there's no mechanism for FDA to come back and says, " Yes, we agree with you or no, we don't." As a result, companies that have wellness devices on the market are to a large degree proceeding at risk, because there is no way for them to ensure that FDA sees it that way as well. Now, I have strategies because as you mentioned Jon, I do a lot of work in this area. I have strategies to mitigate that risk, but we could mitigate that risk much, much further if we had a mechanism. I would suggest a form of a pre- sub, a form of a pre- submission, although it might be a little bit of an oxymoron when you think about it Jon because a pre- submission meeting assumes that it's a meeting before there's a submission. With a wellness device of course, there is no submission. So, how can you have a pre- sub without a submission? But nonetheless, that's just a matter of semantics, that's a solvable problem.

Jon Speer: Yeah, we just call it a pre- market meeting with FDA.

Mike Drues: Whatever... yeah, Shakespeare wrote by the name still smells it's sweet. Whatever we call the meeting, I could care less. What we do need is a mechanism to have a meeting or at the very least, a mechanism to be able to make a, I'll put it in air quotes, a submission to let FDA know that, " Hey, here's our device, we're putting onto the market without anything from you because it is a wellness device." And you know what Jon, let me take that just a half a STeP further. You remember up until just a few years ago the reason why a 501(k) is called technically a pre- market notification, is because it was not an approval. The way it worked up until just a few years ago was literally a company would notify FDA of their intent to market this device. Unless FDA came back within X number of days and said you cannot, then the company could go ahead and do it. In other words, there was no clearance letter or anything like that. Maybe we do something like that for a wellness device. Maybe a company can notify the FDA of their intention to market a wellness device and unless FDA responds within X number of days, the company can go on their merry way and do it. That would eliminate a lot of the problems that I see some companies get into when they put devices on the market under the wellness exemption, that quite frankly are not wellness devices and as a result, they get in trouble for it. What do you think of that Jon?

Jon Speer: Well, I think it seems like at least logistically as far as things go, a relatively simple thing to implement. Seems like it would remove a lot of ambiguity. I think it seems like as far as things go, it seems like this would be a relatively simple thing to do. I didn't realize that government and simple may not be in the same sense a lot of times. But as far as things like of that nature, I mean and I think it's a good idea because wellness devices is it seems like certainly since you and I have known each other over the past a handful or so years, that's been an area of huge growth, right? And because there's little to no policy or mechanism for wellness device companies to communicate with regulatory authorities, there is ostensibly a lot of risk that is out there, not just from the company's sake, but also potentially from the FDA sake. So, why not lean into it, instead of be silent about it. So, I think it's a good idea.

Mike Drues: Well, thank you. And by the way, I have made that suggestion to FDA many times and regrettably Jon, I would have to agree with you as a consultant for the FDA myself to put the word simple and government in the same sentence is sometimes a little bit difficult to do. But to be fair, I have the same frustration with some of the very large medical device companies that I work with as well, because they have just as much, let's call it, bureaucracy-

Jon Speer: Bureaucracy, yeah.

Mike Drues: ... asthe government does sometimes, but that is a topic of a different discussion.

Jon Speer: Absolutely. We talked about 501( k) briefly and talked a little bit about predicate creep over time. One of the other challenges that I see a lot of companies like they'll get their initial 501( k) clearance, and then they'll make a change, and they'll make a change and they'll make a change. And each of those individual changes in and of themselves might not justify a warrant, an additional 501(k). And you and I've chatted a little bit about this I think on podcasts and certainly in our one- on- one conversations in the past. But over time, a couple years later, there might have been handful or so changes to a product that received clearance that you follow the guidance from FDA. None of those had necessarily indicated or warranted an additional 501( k), but what are your thoughts about some follow- up 501(k) or some sort of, " How do I communicate? Hey FDA, from then until now, we've made these changes, here's my mechanism"? What are your thoughts about that?

Mike Drues: Yeah, great question Jon. I mentioned earlier what I think of as the Achilles heel for the 501( k) predicate creep. What you're describing now is what I call change creep.

Jon Speer: Change creep, yeah.

Mike Drues: The idea is very simple. We bring up a device onto the market under the 501( k), and then we make a change to it. It's a relatively minor change, so we don't notify the FDA with the special 501( k), and we handle it via what we call a letter to file. And then a little further down the road, we make another change to it. We don't notify the FDA. We handle it as a letter to file. A little bit further down the road, we make yet a third change to it and we don't notify the FDA. We do it as a letter to file. Sooner or later Jon, when you look at those changes individually, when you look at them incrementally, they might be considered relatively minor, relatively non- significant changes. But when you start to add them together over a period of months or years, this is not just true for physical or mechanical devices. This is especially true for software devices, where the code is changing and morphing all the time. So, how is it Jon that we have now gotten to the year 2022 and we still don't have what I and some of the other folk like to call a catch- up 501( k)? I don't mean ketchup in the hot dog and mustard sense of the word Jon, and it reminds me of the famous ketchup and mustard video that you did many years ago, which I still use to this day in many of my trainings on substantial equivalence, but why we don't have a catch- up 501( k) as part of official 501(k) vernacular? It absolutely astounds me. Now, this is a perfect example Jon when I said earlier. I want to make this pragmatic. I would like FDA to create a catch- up 501(k), and I would be more than happy to work with them to do it. But in the meantime, I refuse to use regulation as an excuse to hold me back. In other words, I've had many companies tell me, " Well, we would like to notify the FDA of our changes. However, there is no mechanism to do it and therefore, we can't notify them." With all due respect, bull you know what. We need to figure out a way in order to notify. There's one way to do it. What I often recommend to companies because I do a lot of work in this space is take all of these changes and package them together in a special 501(k). And maybe the main objective of that special 501( k) would be to make a significant change to your device, for example, adding a new indication or changing sum of action or something. So, you're going to end up submitting a special 501( k) anyway. Well, if you're going to submit a special 501( k) anyway, why don't you use that as an opportunity to embed those other changes in the same 501( k)? And when you present it to the agency, you say, " Look, as a matter of professional courtesy, we want to notify you of these changes that we've already made over the last X number of months or years or whatever it is. And oh, by the way, here are all the reasons why it is justified to do these as a letter to file, and now we're putting it into our special 501(k) and move forward from here." It's a clutchy solution Jon, I'll admit, but unless and until we actually have a catch- up 501( k) or something substantially equivalent to it, I don't see a better solution to that problem. Do you, Jon?

Jon Speer: Well, as you talked a little bit about that it, I remember a few years ago when I dove deep into the FDA's case for quality initiative, and specifically I remember their initial focus on the case for quality was focused on PMA devices, class three devices. And one of the things that they learned before kicking out off this case for quality initiative is that a lot of companies were not making changes to PMA devices, because the regulatory hurdles and burden is too great. They knew of changes to improve the product, but because of the barriers and the constraints and the obstacles and roadblocks that were required from a regulatory perspective, these companies were sitting on these changes. This is a case that's you may be more of an extreme example, but the 501( k) does give you a little bit more I'll say freedom to operate so to speak. And best practice companies are going through those decision trees and documenting their decisions and letter to file. I think it's just a good mechanism to be able to say, " Hey FDA, we've made these changes and here's why we made those changes, and here's how we derived that the decision of letter to file and so on and so forth, but it's all about this continuous improvement." And I think this is continuous improvement should be one of the things that we strive for as medical device companies, and I'm glad to hear that you don't let the lack or current regulatory framework become an obstacle, or an impediment for you and your clients, because I think it's just good practice to be able to say, " Hey, this is what we're doing and this is why we're doing it."

Mike Drues: Well, regrettably Jon, there's a lot of truth to what you said in the class three PMA universe. When a company brings a device onto the market, they don't want to make a change. That's really one of the biggest problems that the drug world faces. Because when a drug company gets a drug approved, they don't want to do anything. I literally mean anything to change it, because of the reasons that you just suggested. In the class three, in the PMA universe, it's not quite as bad as in drugs, but it's much, much more challenging than in the class two universe.

Jon Speer: For sure.

Mike Drues: And I love the phrase that you use in the class two world. We have more of freedom to upgrade if you will. We have more freedom to changes than we do in the class three universe, or certainly in the drug universe for all of the obvious reasons. I mean that to me goes without saying, but here's one other suggestion along those lines Jon under the category of improving our methods of communication with the FDA. Why not yet another pre- sub? As you know, I'm a huge fan of the pre- sub process Jon, where separate and distinct from a special 501( k), we could go to the FDA to vet a letter to file or a series of letters to file maybe before we implement them, just to make sure that FDA agrees that, " Hey, this is a legitimate letter to file, as opposed to something that would require either a special 501( k) or in the PMA world, a PMA supplement." One of my customers last year Jon, they got into a huge amount of trouble, because they made some changes to their device on the market without going to the FDA first. And as a result, the FDA found out about it, and I'll spare you the gory details, but you can just imagine the potential outcome there. So, we need to be more proactive, as opposed to reactive and some of the things that we're talking about here I think would really minimize, if not eliminate a lot of the problems that companies run into.

Jon Speer: Mm-hmm (affirmative). So, let's maybe shift slightly and think about what's might be missing from a manufacturing point of view. And I guess to set that up a little bit, as a medical device company, one of the things that happens as part of normal course of operation is from time to time, the product specific or product dependent or product influence rather for sure, but I should expect I'm going to be inspected from time to time by FDA. And as a result of that FDA inspection, I could have issues that are identified in the form of 43 observations, or possibly even warning ladder, hopefully not, but it happens. And now me as manufacturer, I need to take action to address those issues. I've been through this unfortunately a time or two, largely in consulting trying to help companies get out of some trouble so to speak, or address 43 observations, or warning- led issues. In that dialogue or that exchange of information from FDA, man it is far from ideal. So, what do you think is missing from that perspective?

Mike Drues: Yeah, great question Jon. And once again, I find it fascinating, not a criticism, but simply an observation that we are now beginning 2022, and we do not have a formal mechanism of communication to address concerns related to 43s or as you suggested Jon, wurst warning letters. When a company, and that's happened many times, I know you have as well, when a company gets 43 observations, or when they get a warning letter and they try to address them, they implement changes, whatever it is, having some mechanism may be yet another form of a pre- sub. Although in this particular case, it would be I suppose a post- sum because it would be after the submission. The device is obviously on the market, but again what you call it, I don't care. Some way that you can formally present and ideally meet with the agency to say, " Hey, these were the problems that were identified before. These are the actions that we took to try to prevent them or correct them. Just want to make sure prior to you coming on knocking on our doors and again in the future and saying no, no, no, sorry, this particular fix doesn't fix the problem. Just want to make sure that in your book, this also solves the problem. I don't think there's anything unreasonable about what I'm asking for." When FDA says we want to work collaboratively with industry or when industry says we want to work collaboratively with the FDA, I say, " That's great, but prove it. Where's the evidence that we're actually doing that?" I don't see a lot of evidence that we're doing as good of a job of that as we could be.

Jon Speer: Yeah. And on that topic specifically, and I think what I'll describe is a fairly typical process, you have FDA inspection, issues are identified. Me as company, I now work diligently to try to... hopefully, I had good exchange of information with the FDA investigator. Hopefully, I asked enough questions to truly understand, but regardless, now diligently, I'm scrambling the team together to try to figure out our initial response. I type it all up. Yes, I do send it electronically, but then it's like it might as well be sending it in snail mail because I may or may not hear back from the agency, but now I feel this pressure. I have to take action, and I'm going to cross my fingers and hopefully take the right action. But if I knew what the right action was, I probably wouldn't have had the issue to begin with, but I have no collaboration with the agency. So, I take these actions and then I send another update and then again crickets, I don't hear anything. Eventually, I'm going to say, " I've addressed all these things," and then the FDA is going to say, " Great, we're going to send another investigator out. We're going to do a follow- up inspection," and you may or may not have done or addressed the issues to their satisfaction. So, that lack of exchange of information just creates a lot of frustration.

Mike Drues: As you pointed out yourself at the beginning of our discussion today Jon very succinctly, but very elegantly, do we want to be proactive or do we want to be reactive? What I'm trying to share here both for my industry friends, as well as my FDA friends is ways that we can be proactive and try to PACAs rather than CAPAs, prevent problems as opposed to correcting them once they happen. And I'll give you a quick example going back to one of the things you mentioned a moment ago in the class three universe and how companies, they don't want to make improvements to their devices or their manufacturing processes because they're afraid that that's going to open up a Pandora's box when it comes to FDA and so on. Some of the companies that I work with, not many, but a few of the largest companies that I work with as a matter of company policy Jon, they have told their R and D engineers only to make changes to a device that's on the market to the point where we can handle those changes as a letter to file, do not pass that magic line of what would be necessary for a special 501(k) or a PMA supplement. And the reason why that makes my blood pressure go up Jon as a biomedical engineer and a former R and D engineer, can you think of any better way to prevent innovation, to prevent improvements than by giving your R and D engineers that kind of a mandate? Don't make changes that go beyond a point where we would have to notify the FDA? I'm sorry Jon, but that I don't think is any of our best interests.

Jon Speer: Yeah, yeah, that's a whole different show in and of itself. You changed topics slightly. So, one of the notes that you sent over is the question along the lines of you're talking about a de novo version of PMA, and I was thinking about that a little bit. And I was a little confused because to me PMA, not always, but I mean de novo I guess rather, when I think of de novo, I think of something novel and new and unique. Not all PMAs are novel, new, unique, but a fair amount are. I guess what are you thinking there, a de novo version of PMA?

Mike Drues: Well, I guess I would respectfully challenge your last premise Jon that when you said a lot of PMAs are novel or unique. On the contrary. I would argue that just like in the class two 501( k) and de novo universe, the vast majority of PMAs are in fact not novel or unique. They are high risk. They are class three devices, but bare metal stands, no, there are dozens and dozens and dozens of bare metal stents-

Jon Speer: All right, cliché, yeah.

Mike Drues: ...but they all basically work the same. They're all PMAs. So, the question is should we treat all PMAs equally? They are all class three devices, but should we treat them all equally in terms of the testing that's necessary, benchtop, animal, clinical, in terms of the review that's necessary by FDA? In the class two universe Jon as you know, we do not, underline not treat all class two devices as if they are the same. Some class two devices, the majority of the devices that are me two devices, those are 501( k) applicable and those are relying usually on a well- established technology. They can get away with less rigorous testing, less rigorous review and so on. On the other hand, other class two devices that aren't truly new or novel that might use a new mechanism of action, or that might go after a new indication, the technology is not well established, so the burden is higher in terms of data testing, benchtop, clinical, sometimes clinical or animal. The review by the agency is more thorough. It usually takes longer. Does it make sense to treat all PMAs the same. If we have a me too PMA, what I like to call a 501( k) like PMA...

Jon Speer: So like substantial equivalents are incorporating that to the PMA world?

Mike Drues: Yeah. Well, you know what Jon, it's interesting because sometimes people will ask me, is there a concept of substantial equivalence in the PMA world, or can we use a predicate for a PMA device? Well, every regulatory textbook will say and probably 99.9% of the regulatory professionals will say that, " No, there is no concept of substantial equivalence in the PMA world. You cannot use a predicate in the PMA world." Well, I don't care what the majority says. I don't care what the textbook says. I use the concept of predicates or substantial equivalence in the PMA world all the time. And just as a reminder for our audience Jon, a while ago, I did a webinar on the PMA for Greenlight Guru, and I talked about this in more detail. But in a nutshell, I use the concept of substantial equivalence or predicates for last three devices, not in the regulatory sets, but in the engineering sense. And specifically, what I mean by that is in terms of testing and in terms of risk mitigation. In other words, if my technology is similar to another device that's on the market as a class three device and the testing that they did, might be applicable to the testing that I need to do. So, I'll use that in a substantial... On the risk mitigation side, if my technology is similar to another device's technology, it stands to reason that some of the risks for the other device might be applicable to my device. So, I'm using the regulatory logic of substantial equivalence in the PMA, in the class three universe all the time. I'm not using it in a regulatory sense. I'm using it in the biomedical engineering sense, but that brings us to the current question Jon, because that I've been doing a long time. What would be so bad about actually having a formal concept of substantial equivalence in the class three universe? Again, I'll go back to the stent example. We have dozens and dozens of bare metal stents.

Jon Speer: Absolutely.

Mike Drues: Yeah, they all have slightly different shapes. They have slightly different materials, but at the end of the day, the mechanism of action is exactly the same. So, why can't we still have a class three PMA device, but use a substantial equivalence- like argument? In other words, create a 501( k) version of the PMA, and then we have a de novo version of the PMA. And by the way Jon, one of the potential advantages of doing that is it would allow us to apply our resources much more efficiently.

Jon Speer: Absolutely.

Mike Drues: And when I talk about resources here, I'm not talking about just the company. I'm talking about the FDA, because why does the FDA need to apply the same amount of resources for a 501(k) PMA, as opposed to a de novo PMA? We don't do it in the class two universe. My question to you and to the rest of our audience Jon both in industry, as well as FDA, if we don't do it in the class two universe, why don't we, why can't we do it in the class three universe? At least it's something that we should talk about.

Jon Speer: It's interesting because to your point, I mean all PMAs are treated equal so to speak, I mean with the rigor, the expectations and so on and so forth. But to your clarification, there are plenty of PMAs that are, let's be honest, me too products, right?

Mike Drues: Yep.

Jon Speer: The stent is a great example. So, maybe more that predicate or that substantial equivalent should be the me or the primary basis of my PMA, rather than link the extensive clinical trials and things that nature.

Mike Drues: Let me give you one other quick advantage of a 501( k) like PMA. I gave an example of an advantage for the FDA being able to apply more resources to a de novo like PMA, as opposed to a 501( k) like PMA. But on the industry side, you and I both know because we both work with a lot of small and startup companies. If you go to a potential investor, an angel or a VC and say our device is a PMA, then pretty much the investor is going to say, "End of discussion and don't let the door hit when you're on the way out." However, if you go to the potential investor and say, " Yeah, our device is a PMA, but it is a 501( k) like PMA, as opposed to a de novo PMA," I think it might be easier, might be more palatable for that investor to sign the check. And you and I have talked about this before Jon, this perception in the industry, especially in the investor community that PMAs are so much more time consuming and expensive and risky and so on. It's really holding us back. There are a heck of a lot more devices that we could and should have out there that we don't, because we don't have a 501( k) like DNA.

Jon Speer: Well, the last thing I'll say on the PMA path and then we can maybe shift gears a little bit, is the things that you have to do for a PMA product don't always make sense.

Mike Drues: Why would you limit that statement Jon just to the PMA world?

Jon Speer: Well, oh, yeah, okay. But it seems to be more egregious in the PMA world, than it does in may be a 501( k) type product. One of the recent conversations you and I talked about the EUA and the state of affairs there, not to rehash that, but we talked a lot about basically helping people understand, " Hey, this EUA thing is coming to an end. We don't know exactly when, but sometime soon. And EUA is not a forever permission to have your medical device on the market, and companies need to be doing some follow- on activities and that sort of thing." But the reason I bring that up a little bit is this isn't exactly accurate, but I think for the sake of conversation, well it'll trigger some thoughts I'm sure, but EUA is meeting a need. The intent behind it is to meet a need of a pandemic, in this case COVID, but there is precedent I think for addressing, or getting products that address a safety need, or getting a product to market more quickly that are proven safe rather. And then being able to do some follow- on activities at a future date and time to demonstrate efficacy. So, I fumbled through that a little bit, but what are your thoughts about allowing some lower barrier to entry for a product that's demonstrated as safe with maybe, and this probably is regulatory risk here, but with the I promise statements that I will gather data on its efficacy and follow back up? What are some thoughts about that?

Mike Drues: Well, first of all before we get to the latter part of what you're describing in the regulatory world Jon, what we call a promissory note, I'm really glad that you mentioned the EUA, especially at the end of our PMA class three discussion and the reason why. There is precedent for this 501( k) like PMA idea, and the EUA is the perfect example. What I mean by that is the vast majority of EUAs that have been authorized by FDA to date are what I call 501( k) like EUAs. In other words, they are devices that are usually already on the market for something else, and then the company has gone to the FDA with an EUA specifically to add the COVID indication. Basically, they're showing that their device is substantially equivalent to the previous device with the addition of the COVID indication. That's the reason why, not the regulatory justification, but the biomedical engineering justification that EUAs can go through the system more quickly if it is a 501( k) like UA. On the other hand, there's a very, very small and I literally mean small number of devices that are what I call de novo like EUAs, where this is not a existing device. It's a new device, it's not on the market for anything yet. It might use a totally new mechanism of action that is not established that's never been used before, and I have some companies Jon, one in particular that had a really hard time understanding why their EUA taking so much longer to go through the FDA than all of the other EUAs. And I've said to them many, many times that regrettably, you are not a 501( k) like EUA, you are a de novo like EUA. So, this concept of a 501( k) like PMA or a de novo like PMA, it's not a foreign concept. As we've talked about before Jon, we have tons of regulation already. We don't need more regulations. What we need is more people understanding the regulation that we already have and figuring out ways to apply it, and apply it in different ways. And that's what we're talking about here. Coming back to your last question Jon about the promissory note, I think what you're referring to there is an idea that's actually been floated around now for a couple of years, and that is having a safety only approval. In other words, when bringing a device or for that matter, a drug onto the market to show that the device is safe, never mind efficacy, but just to simply show that it's safe and then as you suggested, maybe efficacy can be shown later through post- approval studies or something like that. As a matter of fact Jon, some people have even taken that even further. They've suggested that FDA has no business regulating efficacy. They should stick only to safety. Who do you think would be better regulating efficacy?

Jon Speer: Yeah, sure.

Mike Drues: CMS, Centers for Medicare services because believe me Jon, regardless of whatever FDA approves or doesn't approve, if CMS doesn't see an efficacy benefit, what I mean there is a cost benefit-

Jon Speer: There'll be no...

Mike Drues: ... they ain't goingto reimburse and as a result, most people are not going to use it. Some people would argue that FDA should be limited to just safety, and CMS should be the ones that handle more the efficacy piece. I think it's an interesting idea. I'm not completely sure where I fell on that one personally Jon. I've thought about this idea for a number of years, but I do think it's another idea that's worthy of a lot of a discussion. One of the advantages for industry though is if we only had to show safety of a product of a device, then we would be able to theoretically get that device onto the market probably much quicker with less testing. Most interesting to me though Jon is the last time this idea was officially floated, which was about two years ago, the proposal to FDA was specifically for class three devices, not class two or even class one devices, but class three devices. I'm thinking to myself, " Oh gee, if you want to start this as a pilot program, okay, fine, I have no problem with that, but why are you going to start that with the highest risk devices? Why not start it with the low- risk devices?" But that is a topic of a different discussion.

Jon Speer: Yeah. I know you and I have chatted about breakthrough device program and as well as, the STeP, the safer technologies program. And I know there's a lot of confusion. I know some companies who get their BDP, they look at that or even STeP, they're almost looking at that as the mechanism that they get FDA clear and that sort of thing. So, I know there's confusion there, but why do we have these programs if they aren't... I mean is it purely about marketing? Is it political? Because they're not pathways. I don't know, help me out a little bit here.

Mike Drues: They are not pathways, you're right Jon and we've talked about both the BDP as well as the STeP and other podcasts. And I've done some webinars on these as well. So, we can share those resources with our audience, but the question here Jon is in terms of improving the regulation and improving the efficiency, why the heck do we have a one program for a BDP and a separate program for STeP? Yes, the objectives of the two programs are different. The objective of the BDP is to show an increase in efficacy, whereas the objective of the STeP is to show an improvement in safety of the device, or the procedure in which it was to use. But other than that, the two programs are exactly the same, or at the very least substantial equivalent. So, I don't see the necessity of having two separate programs. I think they could be easily combined and even more importantly Jon, I have a big issue because as you know Jon, I have now about a dozen devices in the BDP program, so I don't think there's probably anybody that has more experience in this area than I do. Why is it that we can't include a BDP objective in existing, in a traditional pre- sub? In other words, if a company wants to submit a BDP, they have to do it separate and distinct, separate pre- sub. You cannot as I like to say co- mingle objectives. If you try and I've tried this before, FDA will throw it right back in your face.

Jon Speer: Oh, that's just...

Mike Drues: I see absolutely no reason why we cannot, or at least we should not have the option to combine or co- mingle them, that we take all of the normal objectives of a traditional pre- sub, the regulatory strategy, the testing matrix, the clinical data plan and so on, and then we just add another one to the list and that is the BDP or the STeP. To me, that would be a much more efficient process than chunking it up and having so many different pieces, but that's a relatively minor suggestion Jon.

Jon Speer: Well, yeah, I mean, but it seems that at the end of a pre- sub, that's part of the decision. Does this product qualify for BDP? Does this product qualify for STeP? Yeah, that's an outcome, but anyway, there's thing that...

Mike Drues: Yeah. Anecdotally, I have had traditional pre- subs where just as a side note, the reviewers have said, " Hey, this is an interesting technology. Why don't you consider throwing it in as a BDP or as a STeP?" Some of the reviewers are already thinking in that direction from their point earlier Jon. This shouldn't be a difficult, a complicated problem to solve, but again, we are talking about large organizations here. So, maybe it's not quite as simple as you and I would like to think it is.

Jon Speer: There's probably a lot of other things, but in the interest of your time, my time, and listeners' time, let's start to put a wrapper on this conversation. So, what else is important? What else big things do you think are missing with respect to regulatory vehicles or mechanisms or opportunities to improve upon our current systems?

Mike Drues: Yeah, great question. And the last one that I would throw into my laundry list of what Mike would like in the ideal regulatory system, which is not what we have today. It's pretty good, but it's certainly not perfect is look, we really need a new pathway for personalized medicine, whether we're talking about personalized medicine of medical devices like 3D printed devices. You and I have talked about that a bit before Jon, and I do a ton of work in that area, or personalized medicine for drugs when we talk about pharmacogenomics and so on. Either way, there's a heck of a lot more similarities than there are differences, but we need a pathway specifically for personalized medicine. Contrary to what my friends at FDA would say, I believe the best pathway that we have right now, it's not a perfect pathway, but the best pathway that we have right now, for example, 3D printed devices is the CDE, is the custom device exemption. Even though FDA has flat out said in guidance that the CDE should not be used for 3D printed devices or personalized devices, I strongly disagree. But that said, I think that we need a new pathway, a better pathway. Now in the interest of full disclosure, as you and your audience probably know Jon, we have now somewhere north of 100 devices that are 3D printed that have been brought through the FDA. I've had my fingers in many of them, certainly not all of them. I have brought more devices that are 3D printed onto the market under the 501(k) than anything else, even though I have said publicly many times that the 501( k) in my opinion is not the ideal pathway for personalized medical devices. But in the absence of something better and in light of FDA's feeling that the CDE is not the appropriate pathway, okay, what do I have left? I can't say to my customer, " Well, I'm sorry guys, but you have to wait five or 10 years for our government to create a new pathway." No, no, no. As I said before, I refuse to use regulation as an excuse to hold me back. Given the choices that I have today, even though none of the current choices are perfect choices or even good choices, I have to use one of them to get the job done, but would I like a new pathway, a better pathway? Absolutely and I have a lot of thoughts on what that pathway might look like. And to be fair, we have had conversations at FDA over the years about creating such a pathway. But unfortunately Jon, it is taking so long, it's really holding us back. So, that I think is another big gap moving forward, begin 2022 and beyond when personalized medicine is clearly the future for a whole bunch of reasons.

Jon Speer: For sure. Yeah, for sure and maybe that is a takeaway. I don't know that it's all the takeaways today. But from this conversation, one of the takeaways that I've heard is well, there's things missing in our current regulatory framework from FDA as we've chatted about today. And a takeaway should be don't let that stop you from making progress, don't let that stop you from figuring out how to navigate the current options, the current pathways, the current system if you will to move forward. I guess to wrap things up, what takeaway would you like listeners to leave with today?

Mike Drues: I could not agree with what you just said more Jon. Two takeaways. One, is the system is not perfect, and we need to have discussions like this, and in as many different venues as we can on how to make improvements and create new pathways and so on. Quite frankly, if I can be blunt here, there's too much of the blame gate. There's too much pitching and moaning and groaning about what we can't do, or we could do this, but FDA won't allow us to. That's not a productive discussion. What we need to have is a discussion I've tried to do this as much as I could today, very specific, concrete, pragmatic suggestions. Maybe some of these suggestions have merit, maybe some of them don't, but at least it's a starting point to have the discussion. In the meantime, that's under the category of what I call altruism, making the world a better place. In the meantime to your point Jon and as I've said before, don't, underline don't use FDA or regulation as an excuse to hold you back. Give this to my customers all the time. If you have an idea for a new device, as long as you can sell it to me based on the biology and the engineering, don't worry about the regulatory. We'll figure out a way, I'll figure out a way. I pride myself in what I call creative regulatory strategy. I'll figure out a way to get it through the FDA, but please don't use FDA or regulation as an excuse to hold you back, because that is not the way this game is supposed to be played.

Jon Speer: Yeah, absolutely.

Mike Drues: Those are my takeaways. Jon, anything you want to add to the list?

Jon Speer: Well, I'll just wrap it up by saying you heard Mike, his last words are so true. You maybe feel a little bit stuck, or need to figure out a way to navigate the options in front of you. Well, Mike Drues of Vascular Sciences is a masterful artist when it comes to creative regulatory strategy. So, reach out to the guy. He'll help you figure out how to navigate this. Just because 501( k) is a workhorse does not necessarily mean that you need to shove all of your device submissions into that 501( k). Maybe there are other options or other things that you could consider, and Mike is one of the best, if not the best at figuring that out, so reach out to him. As always, I want to remind you that Greenlight Guru, we're here to help as well. We have a software platform to help you document and manage all of these activities as you're going through design and development and risk management, as well as post market and maintaining those products on the market, and making sure that you're capturing what you need to from a document and record standpoint and from a quality event perspective. We have the only medical device success platform on the market today designed specifically and exclusively for the medical device industry by actual medical device professional. If you'd like to learn more about the workflows and how our products and services might be able to help you, it's pretty simple. Go to www.greenlight.guru and if you'd like to reach out to us to have a conversation, just click the button, fill out the contact us, and we'll have a conversation with you, see if we might be able to help. So, encourage you to check that out. Lastly as I wrap things up, I want to thank you for listening and watching the Global Medical Device Podcast, the number one podcast in the medical device industry, and that's quite simply because of you and you continuing to spread the word with your friends and colleagues. So, thank you for doing so. As always, this is your host and founder at Greenlight Guru, Jon Speer and you have been listening to the Global Medical Device Podcast.




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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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