Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.

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Some highlights of this episode include:

• Basic Requirements: Safety and Performance Based Pathway only eligible to Class II or lower medical devices and must show substantially equivalent predicate(s) already on the market.
• Indications for Use: Medical devices must offer high-level labeling and technological characteristics that don’t raise additional safety and efficacy issues. 
• Medical Device User Fee Amendments (MDUFA): Should 510(k) submission fees be cheaper and approval be made faster to meet predetermined standards?
• FDA’s finalized guidances and current status of Safety and Performance Based Pathway
• FDA draft guidances related to the Safety and Performance Based Pathway
• Medical Device Pros and Biomedical Engineers: If you’re working in an area that is well established and do not already know what standards apply, what testing needs to be done for your device, maybe consider a different area or role.
• Suggested Improvements: Look for similarities where no similarities seem to exist, such as those between Premarket Notification 510(k) programs, De Novo, and other FDA market pathways.
• Are additional regulatory guidances wanted or needed on device- and technology-specific materials, diseases, or design controls?  Be a leader when so many medical device professionals want to be told what to do.

Links:

FDA - Medical Devices

Safety and Performance Based Pathway

Medical Device User Fee Amendments (MDUFA)

Premarket Notification 510(k)

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway (Global Medical Device Podcast Episode 97)

How EU MDR Changes are Impacting the Medical Device Ecosystem (Global Medical Device Podcast Episode 144)

EU MDR

Cutaneous Electrodes for Recording Purposes

Conventional Foley Catheters

Spinal Plating Systems

Orthopedic Non-Spinal Metallic Bone Screws and Washers

Magnetic Resonance Coils

Soft (Hydrophilic) Daily Wear Contact Lenses

Product Development Protocol (§814.19)

De Novo

Design Control Guidance

Center for Devices and Radiological Health (CDRH)

Mike Drues on LinkedIn

Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device? (Greenlight Guru Webinar) 

Greenlight Guru Partner Programs for Medical Device Consultants

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable Quotes from this episode:

“The Safety and Performance Based 510(k) is very similar to all the 510(k)s. We have to show substantial equivalence to something. It’s just that the ‘something’ is different.” Mike Drues

“Look for similarities where no similarities seem to exist.” Mike Drues

“Put the burden on industry, not the FDA.” Mike Drues

“Be careful what we wish for as an industry. If we want more guidance from FDA, they will tell you exactly what to do, when to do it, and how to do it.” Jon Speer

Transcript:

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: On this episode of the global medical device podcast, Mike Drues from Vascular Sciences and I revisit the safety and performance 510( k) that FDA released a little over a year ago and we dive into some of the details and explore how this might be a potential pathway for you to consider. 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 and founder at Greenlight Guru, John Speer. There's a lot of things that are happening in the regulatory side of our industry, even back a little bit ago there was a newer program, let's say from the FDA called the safety and performance 510( k) and you might recall that Mike Drues from Vascular Sciences and I talked about that at that point in time, and we haven't revisited that topic. But there's some recent news on the safety and performance space 510( k) that I thought it might be good to revisit the topic a little bit. So joining me on this is Mike Drues. Mike, welcome.

Mike Drues: Thank you, Jon.

Jon Speer: So I use the word new, and I guess from a regulatory perspective, this still is a new program and I might be a good place to start to remind folks what the safety and performance based 510( k) is all about, and maybe highlight a couple of tips or pointers or key differentiators from other 510( k) s.

Mike Drues: So Jon, that's a great place to start and as always, thanks for the opportunity to discuss this with you and our audience because this is a pathway that everybody in our audience should at least be familiar with to determine whether it's applicable for their particular device or not. So, first of all the safety and performance based 510(k) or SP 510( k) as I like to call it, it's just another 510( k), and like the other 510(k)s there's a couple of basic requirements. The first is it only applies to medical devices that are class two or lower. Class two or lower so if you have a device that is a class three device, no 510( k), including the safety and performance based 510( k) would normally be applicable. Then the second requirement, like all other 510(k)s is we have to show that there's a predicate. Another device already on the market here in the United States that is very similar i. e. substantially equivalent to our device. When we talk about substantial equivalents as you know, Jon, we're talking both labeling as well as technology. Now let's dig into that substantial equivalence, just a tiny bit further because all 510(k)s across the board require of showing substantial equivalence to a predicate, but the way we do it for each type of 510( k) is different. So most of our audience are probably familiar with the most common form of 510(k) the traditional 510(k) in the traditional 510( k) or the T510( k) we typically show substantial equivalence to another device already on the market. It could be one of our competitor's devices. It could be one of our devices that doesn't really matter, but we show substantial equivalence to another device already on the market. About 70% to 75% of 510( k) s are traditional 510( k) s, special 510( k) s typically used when we make a change to an existing device. We have talked about these topics and other podcasts before, but special 510(k)s we still have to show substantial equivalent, but we have to show that our changed or our modified device is substantially equivalent to the previously cleared device. So the substantial equivalence argument is the same, but we're comparing it to the previous version, if you will. By the way about 20% of 510( k) s are special 510( k) s case. Finally, we get to the topic of today's conversation and that is the safety and performance based 510(k) which is really nothing more than sort of an update of what used to be called the abbreviated 510( k). Once again, we still have to show substantial equivalents, but in this particular case, instead of showing substantial equivalence to another device like the traditional or the special 510(k), we show substantial equivalence to a standard, to a guidance, not a particular device itself. We can dig into this a little bit more as the conversation continues. The abbreviated 510(k) which has now essentially become the safety and performance 510(k) in the past has not been used very often. Jon, as you probably know, only about 4% of 510( k) s were abbreviated 510( k) s. I suspect perhaps, and again, we can talk about this more in our discussion, but if the changes from the abbreviated 510( k) to the safety and performance 510( k) seemed to be attractive to more companies, then maybe that number will increase, but it hasn't yet. So bottom line, the safety and performance based 510( k) is very similar to all of the 510(k)s. We have to show substantial equivalence to something it's just that the something is different than the SP 510(k) we show substantial equivalence to a standard or a guidance as opposed to an individual device. One last thing that I'll mention about the SP 510( k) Jon, and then you can chime in with your thoughts is just like the abbreviated 510( k) the safety and performance based 510(k) is limited to what I like to call well established technologies or well established devices. In other words, if you have a device that has been around for a very long time, that uses a well established technology, then there are probably standards that apply to it. On the other hand, if you're working on a" new device" and I know Jon we've talked about before to put the words new in 510(k) in the same sentence is a little bit of an oxymoron. But if we're working on a" new 510( k)" whatever that means, then chances are, there are not standards for it, because if there were, how could it be new? And if there are enough standards for it, then it would not be applicable to the SP 510( k). So at a high level, Jon, that's sort of an overview of the safety and performance 510(k), and sort of how it compares to the other types of 510(k)s. Does that make sense?

Jon Speer: It does. Anything else that's important about the news safety and performance based 510( k) that's-

Mike Drues: Just a couple of minor points Jon. The SP 510( k) was created about two years ago. It was announced by Scott Gottlieb before he left as commissioner of FDA. As I said, it was basically very closely patterned off to the abbreviated 510(k), I would say it's substantially equivalent to the abbreviated 510( k) to you use a regulatory pun Jon. It is limited to, as I said, not just well understood technologies or well established devices or technologies, but it's limited to certain well understood devices. We'll talk more about that in a moment. But again, to keep this as simple as I can, there's basically two requirements to be SP 510(k) that are very similar to the other 510( k) s. The device has to have the same high level labeling that is the same indications for use, and the technological characteristics cannot raise additional questions of safety and efficacy compared to the predicate. So that's true for 510( k) s across the board. But the difference here with the SP 510(k) is that the new device needs to meet all of the FDA identified performance criteria, which is in the guidance or the standards that we'll talk about in a moment. Just a couple of other minor things that companies should know when considering the SP 510( k), yes MDUFA fees still apply. So a 510( k) user fee is a 510( k) user fee, whether you're talking about traditional special or safety and performance based 510(k). Which begs the question, Jon, shouldn't an SP 510( k) be cheaper because if it's just a matter of FDA determining that, yes, it meets these set of standards and all they have to do is look at the testing results from the company. That's something that quite literally should be able to be accomplished within a couple of hours. But anyway, it's not like a traditional 510( k). The second question is FDA's goal according to the guidance is to make a decision within 90 days for the safety and performance based 510( k). But once again, shouldn't it be faster because all we're doing is we're making sure that it meets these predetermined standards. So I'll leave those two last statements about user fees and review time is sort of rhetorical comments, Jon, but I think that we can do better.

Jon Speer: Yeah. You hit on some key points. The cost certainly, but definitely seems like the review time. Just for context, what is the review time for a traditional 90 days, but can you remind folks what the review time is for a special and abbreviated 510( k).

Mike Drues: Do you expect me to carry those numbers around with me?

Jon Speer: No, no. But my recollection is the special and abbreviated are less than 90 days. Don't quote me on that. I can double check and verify that, but yeah, it does seem like with the safety and performance that it shouldn't also be 90 days, but that's another topic for probably a completely different audience.

Mike Drues: Well, we could certainly provide links to the MDUFA statistics for our audience. I don't remember those numbers off the top of my head, but I can tell you this, Jon, based on my past experience with the abbreviated 510( k), sometimes companies will come to me and they'll say, we want to do an abbreviated 510( k) and I ask them why, because they think it's shorter or faster than the traditional 510( k). That's not necessarily the case.

Jon Speer: Oh, wow.

Mike Drues: For example, the checklist in the RTA guidance for 510(k)s, the checklist for the abbreviated 510(k) is actually longer than the checklist for the traditional 510( k). So abbreviated Jon doesn't necessarily mean what you think it might mean.

Jon Speer: I guess don't always consult a dictionary. All right. So next question that I know you and I talked a little bit about this back in the day and folks I'll provide a link to the last podcast that Mike and I did on the safety and performance 510( k) back when we did that, but why do you think FDA created this? To your point, if I'm hearing you correctly, it seems substantially equivalent to the abbreviated 510( k). So why this new safety and performance pathway?

Mike Drues: Once again, it's a great question, Jon, and it kind of depends on how you define new. In my opinion this is not new and I'm glad you've picked up on my regulatory punch, that the safety and performance based 510( k) is substantially equivalent to the abbreviated 510( k), because I would really challenge anybody, including FDA to point out any significant differences between the two. But to answer your question, John, in my opinion, the reason why this was created and Dr. Gottlieb announced shortly before leaving the agency is pure politics. 100% politics. That is FDA, and this was a couple of years ago, Jon, they needed to be able to compete with the EU in the sense of the new MDRs that were going into effect over there. Because in many ways, and this is a topic of another discussion that we've talked about before, in many ways, the EU and the US systems are converging, but in a couple of important ways they're actually diverging, they're going 180 degrees apart and this is one of them. As you know in the past, Jon in the EU, they were very keen on making what I call paper substantial equivalence arguments. Now, yes, I understand that the EU doesn't use the phrase substantial equivalence, but the idea, the philosophy is exactly the same. So they would allow you, they would encourage you to make paper substantial equivalents arguments for a CE market, at least in the past. Now they're going away from that and they're requiring, or they're encouraging rather more of a head to head comparison to another device. Whereas here in the US with the formation of this new SP 510( k), we're going in the opposite direction. The SP 510(k) is to encourage a paper substantial equivalence argument. As I said, Jon, we're not comparing, we're not testing head to head our device to another device. We're comparing usually on paper, our device to a standard. In other words, if our device meets that standard and all of the other devices also meet that standard, then it stands to reason that our device is substantially equivalent to the other devices. In other words, if A equals B and B equals C, then A equals C, that's the regulatory logic so to speak. But some people might differ, but in my opinion it's pure politics, and as we both know, Jon, there's never any politics in regulations that couldn't possibly be the case.

Jon Speer: That's a sarcasm, Mike sometimes inaudible. Anyway, that is-

Mike Drues: Thank you Jon, I think that was a compliment, I'm not sure.

Jon Speer: It is. My favorite forms of humor are sarcasm and irony and things of that nature. So you're a little more fluid in it than I am at times, but I picked up on that one.

Mike Drues: Some people might describe it a little bit differently, but that's okay.

Jon Speer: Well, we'll leave the naysayers out of it for right now. What is the current status of this new safety and performance 510( k)?

Mike Drues: Great question, and that brings us really to the meat of today's conversation, because this is an update of our discussion from the one that we had about a year ago. So recently FDA finalized a couple of guidances for well- established devices that now can be used as part of this SP 510( k) program. The two guidances, and we can put links from your website, two of these for our audience. The first one for cutaneous electrodes used for recording purposes and the second for conventional Foley catheters. So if you're working either on a cutaneous electrode for recording purposes or a Foley catheter, because these two guidances have been finalized, whatever the heck a final guidance means, Jon, and as you know there's no such thing as a final guidance. But since these guidances have been finalized theoretically, a company can use the SP 510( k) right now to get clearance on such a device. But there's a lot of limitations. You know as well as I do John, these are some of the most boring medical devices because they've been around for like a million years. How long have we been using cutaneous electrodes for recording and how long have we been using Foley catheters? And they're very limited, for example, I have a Foley catheter that I'm working on right now, but it has some bells and whistles incorporated into it to make it anti- microbial. That by definition does not fit the SP 510( k). So if you're working on one of these devices and I don't mean to be too patronizing to people that are working on these devices that have been around for 50 years or more because they are important devices, but if you're working on these devices then you should consider the safety and performance based 510( k) right now. In addition to those two guidances, there are a few drafts guidances that have not been finalized, but again, what's the difference between address versus a final guidance? Jon, there really isn't any. The additional draft guidances that FDA is working on in this program are for spinal planning systems or orthopedic devices that are non spinal metallic bone screws and washers. If you're working on magnetic resonance coils, MRI coils, and finally, if you're working on a soft or hydrophilic daily wear contact lens. These are all the devices and technologies that FDA is working on these guidances they're out in draft form. So even though they have not been finalized, if you're working on one of those kinds of devices, you definitely should look at these draft guidances. I would suggest if you want, be a little proactive and take this to the FDA as a SP 510( k), even though those guidances have not been finalized. But the most important thing that I would mention in this particular area, Jon is with all due respect there are lots and lots of people that are listening to us in our audience, and some of them are very good, very intelligent engineers. If you're working in one of these areas that are very well established, cutaneous electrodes, or Foley catheters or orthopedic screws or something like that. If you're working in one of these areas and you do not already know what standards apply, what testing needs to be done for your kind of a device, then maybe you shouldn't be working in this area. Because to me, these are not regulatory questions these are biomedical engineering questions, and it kind of begs the rhetorical question, Jon and that is, should we expect FDA to tell us what to do. To tell us what kind of testing to do and so on because all of these guidances that I just mentioned, the two that are final and the four that are still in draft form. I know as an FDA consultant myself, there's others in the works that they have not publicly announced yet. Do we really want, or do we really need FDA to be telling us these things? Again, I'll leave that as a rhetorical question, but if you want to chime in Jon, please feel free.

Jon Speer: No. It is a good thought provoking question and I don't really have any commentary other than I agree. This is my role as a medical device professional as a biomedical engineer, I should know these things, especially for well- established technologies for sure. Mike, just scratching my head a little bit because the number of product spaces where this new 510( k) pass is even an option that's a drop.

Mike Drues: Pretty limited.

Jon Speer: Yeah, it's pretty limited which raises all sorts of other questions. But I'm curious if you happen to know putting you on the spot a little bit, but if you happen to know how many products have actually been through the safety and performance 510( k) pathway, do you have any statistics on that? I can't imagine it's a lot.

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Mike Drues: Prior to our discussion today, I did check to see the most recent quarterly performance MDUFA statistics, and at least that I was able to find they do not specifically call out yet the safety and performance based 510( k). They do still refer to the abbreviated 510(k) as I mentioned before. And as I said, roughly speaking, that has been about 4% of 510( k) s in the past. But I can't unfortunately give you a specific number for the SP 510(k). I can tell you that there are a couple of devices that I've been working on recently that we've considered the SP 510(k) but because of the limitations, I mentioned, the Foley catheter that I'm working on that has the anti- microbial features in it that precludes us from using the SP 510( k). So I always consider it, I always give it to my customers as an option, as a good regulatory professional. I give my customers all of their options, but unfortunately I can't give you a specific number.

Jon Speer: All right. So on the surface, I remember when we talked about this about a year or so ago that I was like, oh wow, this sounds like a really potentially exciting vehicle if you will for some products to work with a... On the surface this seems like it potentially could be a more streamlined pathway to work with FDA. You've highlighted some of the nuances and some of the challenges and today I'm having maybe a different thought. What suggestions do you have about improving the safety and performance?

Mike Drues: I have a number of suggestions, Jon, thanks for asking and I have shared these with the FDA as well. But I know some of my FDA friends listen to our discussions too, so I want to put them out there so we can get more people talking about them, and hopefully if they make sense, go ahead and implement them. First of all, Jon, as you alluded to a moment ago, this is a very limited program. It's only applicable now to a very small number of kinds of devices and technologies. That's kind of unfortunate because that's the way the program has been set up. In other words, we have to wait for FDA to create a guidance, which is nothing more than a set of standards that companies would adhere to, to use the SP 510( k). But if we continue to do this job, this is going to take forever. This is going to take a million years. Quite frankly as I hinted at a moment ago, let me not hint, let me say directly, in my opinion not just as a regulatory consultant but as a professional biomedical engineer, it's not FDA's job to do this, it's our job to do it. So one of the metaphors, one of the themes that I operate by a lot on Jon is, we always to look for similarities where no similarities seem to exist. To me there's a lot of similarities between the safety and performance based 510( k) versus the Denovo and a very little used regulatory pathway to market and that is the product development protocol or PDP. So what are the similarities? Well on the Denovo side, as we've talked about before Jon and I suspect some of your audience knows, the result of a Denovo, and by the way a Denovo is for a truly new or novel device that's less than class two. So class two or below, where there is no predicate. One of the things that results from a successful Denovo is a new product code is created usually with new special controls. Well, these special controls are often standards. So it's the same standards that we're talking about with the SP 510( k). So I would like to see industry take a more proactive approach to using the SP 510( k). I would like to be able to take any device that I want to the agency and say to them, okay, this is a 510( k), but we're not going to do it as a traditional or even a special 510( k), we're going to do it as a safety and performance based 510( k), because we're going to show that it is well established technology, and we're going to show that these are the special controls, the standards, whatever you want to call them I don't care that should be used, not just for our device, but for all similar devices in the future. If FDA buys into that, then they take those list of standards. They put them into a guidance that they want to, and now we have just expanded the program, expanded the number of SP 510( k) devices to be used. So put the burden on industry, not the FDA. The other way that we can, in my opinion, Jon greatly improved the efficiency and I would love to hear your thoughts on some of these suggestions as well, is we can pattern the SP 510(k) as off of the product development protocol or PDP, which I suspect many in our audience probably has never even heard of because it's a very uncommonly used pathway to market. It is a pathway that I described in my pathway that's the way that I described in my pathway to market webinar that I did for Greenlight a few months ago. So maybe it's something we can provide a link to that webinar as well. But basically the idea of the PDP and the PDP of course is for class three devices, but I'm just using the same regulatory logic to apply to the SP 510( k) here. Basically what we do with the PDP is we agree with the FDA in advance as to how we're going to develop and test the device. Then once FDA buys into that plan, if you will, once we complete the work, then FDA essentially, not essentially, but FDA considers it to be done. In other words, the PMA, because this is a class three universe, the PMA is issued. So we could use the same logic here that if we go to the FDA in advance, maybe even create, Jon a special safety and performance based 510( k) precept, where we go to them, we sell them. Here's our plan, here's our testing. FDA says, " Okay, we buy off on that testing." As soon as you complete your testing and assuming your device passes all that testing, then your 510(k) is automatically cleared once that testing has become complete. So I see no reason why, if we can do this for the PDP in the class three universe, granted we don't do it very often. But if we can do it for certain kinds of well- established class three devices, why the heck can't we do exactly the same thing for well- established class two or lower devices? To me, there's no reason why we should be able to do it for class three, which are higher risk devices, as opposed to class two. Do you have any thoughts on any of those recommendations, Jon, the comparison to the Denovo or to the PDP?

Jon Speer: Yeah. Well, just the last thing when you talked about the product development protocol, that seems like duh, that's logical. If it's used for an acceptable option for higher class, why wouldn't it be also an acceptable option for lower class products? So that just seems like obvious, but I don't know. You try and read all the tea leaves with all these things and maybe that's my mistake, but trying to apply logic and rationale to some of these things I'm reverting back to here.

Mike Drues: Well, that's then my mistake Jon, because I do try to apply logic and rationale in the regulatory world all the time. It's not always easy, but I tried maybe that the engineering. Just to be clear, Jon, because I don't want people to misunderstand. I don't want anybody to walk away from this saying this Drues guy must be a wackadoodle because he's saying that a PDP, which is for class three devices is the same as a SP 510(k) which is for class two. No, no, no, no, no. That's not what I'm saying. I'm trying to emphasize that the regulatory logic for the PDP can be applied directly in my opinion, to the regulatory logic, to the SP 510( k). More specifically, again to clarify, and anybody that wants to know more about this, they can listen to my Pathways to Market webinars. As I like to describe it the PDP is essentially it's a contract, it's a meeting of the minds so to speak, between the sponsor and the FDA in order to allow them to reach early agreements in order for the company to know what they need to do, in this case what standards they need to follow to demonstrates the safety and efficacy of their new device. Once you get that agreement, then the manufacturer can move forward at their own pace, and when the PDP or this case, the SP 510( k) has been declared completed by FDA. In other words, you tick off all those boxes, then it's considered to have in the case of a PDP and approved PMA or in the case of a class two device, a cleared SP 510( k). Once again, I see no reason why we can't apply the same regulatory process to both types of the device classifications. I think that would grant greatly and very quickly expand the universe of devices and technologies that the SP 510( k) would be applicable to. Because as you pointed out a few minutes ago, Jon, right now it's very limited.

Jon Speer: The other thing that you said a moment ago, that triggered a thought and it's in pre- submission area. So let's imagine I'm a med device company and I have, I'll just say with respect to the regulatory pathways that are available to me, maybe a fringe case, or I feel as though I have a strong argument, if you will, for leveraging some of these other vehicles that maybe I'm going to do a pre- submission for a 510( k), and I want to explore and uncover the potential for something like leveraging to your point, the product development protocol for my product in some way, shape or form. Have you done this before with like a pre- submission? If so, I guess I'm curious to hear about how that experience went.

Mike Drues: Well, that's a great question, Jon. I have not done it specifically for the SP 510( k). Because as I said a moment ago, I have considered SP 510( k) for several devices, but we haven't taken one to the agency yet because I don't have a device right now that fits into these narrow categories. Believe me, I would love to and when I get to that point, I would absolutely be the first or happy to be the first to knock on FDA's door and say, " Hey, let's use the PDP and the Denovo as a metaphor for doing this for the SP 510( k)." Because after all Jon, somebody has to be first.

Jon Speer: Yeah, why not you?

Mike Drues: Yeah. Why not me? Don't get me started on how I in industry, and again, I'm generalizing here. I know this doesn't apply to everybody, but we have so many sheep and we have so few shepherds. We have lots and lots of people seem to be content to follow along and other people's footsteps rather than being out in the lead and creating the path themselves. But one thing to remember, Jon, I use this in some of my present presentations. If you're following in somebody else's footsteps, there's one thing I can guarantee, and that is you'll never go anywhere new. So something to think about.

Jon Speer: I like that. What else do you think is important about the safety and performance 510(k) that we haven't covered so far?

Mike Drues: Well, I think we did talk about it a little bit, but I think perhaps most important is and to a certain extent I'll offer this as a rhetorical question, but do we need more and more of these device specific guidances. The guidance list that I mentioned a moment ago for the SP 510( k). Each of these guidances, as you pointed out as well, Jon is focusing on a very, very narrow niche, a specific type of device or technology. Well, what does that mean for the future? Does that mean that we're going to have 500, 000 different guidances that are gonna apply to each kind of medical device that you can possibly imagine? In my opinion, Jon that's nuts. Some people would probably advocate that, but I think that's nuts. I've noticed not just with the SP 510( k) Jon, but there's been a trend across the board more and more, very specific guidances coming out of the FDA focusing on specific devices, focusing on specific materials, focusing on specific diseases. In the past, Jon, I'm getting older and you are a little bit too, not as much. Back in the day we didn't have nearly these kinds of regulations. I'll use a metaphor that you're very familiar with Jon, and we talked about this many times, the Design Control Guidance from 1997. That doesn't apply to any one specific device or technology or disease that applies across the board. We talked I think a while ago, our audience I'm sure by now knows that I happened to be a SME for FDA in a few different areas. One of them being bio materials and biocompatibility, FDA shared with me before they publicly released it, one of the new material guidances, this particular one on nitinol and they wanted my comments. They wanted other people's comments as well, but they wanted mine. I basically said to them, " Look, you can issue this guidance." This was about maybe a year or year and a half ago. I said, " You can issue this guidance but there's nothing in this guidance that isn't already in my bio materials textbook as a graduate 35 years ago." They said, " Yeah, Mike, you're right we agree but there's a lot of people that don't know that." So that's the problem. Again, I'll leave it as a rhetorical question but do we need FDA spending their valuable time and resources, and quite frankly, our taxpayer money putting together these very, very specific kinds of guidance. Now, one last thing and I'll be happy to let you chime in on this, Jon. If there's specific reasons for it. For example, in certain categories where there have been problems with devices, silicone breast implants.

Jon Speer: Duodenoscopes, things like that.

Mike Drues: Duodenoscopes, hernia meshes. Then that goes without standing, FDA and industry has to work together to try to prevent those problems from occurring in the future. If it takes more specific guidance to prevent those problems, even though personally, I don't think it's necessary than either, but if it takes that guidance to do it, then I'm by all means for it. But as a general role, and again, maybe some people might disagree with me, Jon, but do we want, or need FDA putting out more and more device specific technology specific, materials specific, disease specific guidances? Because at least in my view, Jon, this is a trend that I've been seeing more and more over the last several years. What are your thoughts?

Jon Speer: A couple of things, to that last point I tend to agree. I'm paraphrasing a great deal, this is John Speer's definition of what FDA and specifically CDRH their objective or mission as an agency is to protect and promote the health of US citizens with respect to medical device technologies. If that is in fact the mission of the agency then yeah, I think guidance on products where there have been some known industry issues, that's a good use of their time. But to your point, I just looked at this Foley catheter guidance and again, no disrespect to anybody developing Foley catheters. There's obviously a need for this technology. It's been around for decades and decades and decades. So there is benefit to this product, but when you read this guidance, man, it is super specific and there's not a lot of gray area and wiggle room and things like that. I think this is sort of the strange dichotomy that sadly, a lot of medical device professionals I think are stuck in. I think a lot of medical device professionals want to be told what to do and I know that's a huge peeve of yours. It is also a similar peeve of mine that careful what we wish for as an industry, if we want more guidance from FDA, they will tell you exactly what to do, when to do it, how to do it. Anyway, those are my reactions.

Mike Drues: But before we wrap this up, Jon because we do, we are coming towards the end here. I'm curious as to your thoughts, we do have these guidances now for the Foley catheters and the other ones that I mentioned. So shouldn't the process be essentially more like a CE mark in that regard? In other words, almost a self certification. If you tick all of those boxes in the Foley guidance or in the surface electoral guidance or whatever, and you submit that to the FDA and FDA says, " Yeah, here's all your test results. You've passed all these tests, go and sell your product and improve patients lives and make the world a better place." Shouldn't it be as simple as that, otherwise what's the point of this program?

Jon Speer: It really seems like it should be. Especially as specific and detailed as the guidance. I didn't look at the cutaneous one and I haven't looked at the draft guidances for the other products spaces that you mentioned, but for this Foley catheter one is super specific. As long as I can demonstrate that, yeah it seems like a self- certify opportunity for sure. I totally agree. Great point. Well, Mike anything else before we wrap up today?

Mike Drues: So just a couple of very quick final thoughts, Jon, and some of these apply to what we talked about today, but others are just applicable across the board. First of all, know what all your options are in terms of your pathways to market. Don't just think of a 510( k) in a ubiquitous sense because there are multiple subtypes, subcategories of the 510(k) as I briefly described at the beginning of our discussion today. We've done podcasts, with Jon and myself on these. I've done webinars with Greenlight specifically on the 510(k). So there's a lot of resources, a lot of information out there on that, know all of your different options. Specifically when it comes to the SP 510(k), which is what we've been focusing on today, obviously use this program if it's applicable to you, if you fit into one of those device types or technologies that I mentioned earlier and use it as a sanity check to make sure that you're ticking, even though Jon, I know you and I both don't like this tick box mentality, but even you're ticking all those standards, we meet all these standards. By the way, Jon don't consider any guidance, including these final guidances as necessarily the complete story, because there might be some testing that you need to do for your particular device that's not in the guidance. That brings me to my last recommendation, Jon, and that is regardless of your pathway. Whether it's the safety and performance based 510( k), or any other 510(k), or any non 510( k) pathway. Please communicate with the agency early before you take your submission to the FDA in the form of a pre- submission meeting or pre sub or some other way. I don't care how you communicate with them as long as you communicate with them and make sure that you come to what my attorney friends like to call a meeting of the mind. In terms of whether or not your technology applies to the safety and performance based 510( k), whether in this case, the testing matrix would be complete. This is in fact the list of standards because I can envision, Jon a scenario, I'm not sure if this has happened yet, where a company is working on one of these Foley catheters, for example, but because there's some subtle nuance in their technology, that's a little bit different. Maybe there's a standard that's applicable, that's not covered in the guidance. So therefore if the company were to go directly and submit the SP 510( k), it would be rejected by FDA because they would say, " Yes, you've met all the standards in the guidance. However, because of this subtle difference in your technology, maybe there's another test or another standard that might be applicable as well." That's a very easy kind of a problem to mitigate if not completely eliminate by taking it to the agency in advance, as I said in the form of a pre- submission meeting or something else. Jon, you and I have talked many, many times on pre subs and we've done podcasts and webinars on that topic as well. So there's really no excuse for folks in our industry to have these kinds of problems because there's just so many resources out there to help. Those are some of my thoughts, Jon, what do you think? Anything else that would be important for our audience to remember as we wrap this up?

Jon Speer: Well, I know if I ever dive into the world of design and development and have an interest in bringing a new product to market, I know the first person I'm calling and calling early in the process is Mike Drues. I'll give you a hopefully what you perceive as a compliment, but I love when you and I talk because you don't think about regulatory in a standard conventional approach, you think about it from a fresh perspective. I have to imagine that every single device that you work on you don't necessarily revert back to, we did this for this product and it was very similar. You're looking at it, it's somewhat uniquely on a per product basis and I think it's a unique approach. I don't think a lot of regulatory professionals do this, so I want to applaud you for that.

Mike Drues: Well, thank you Jon. I do not advocate the word substantially equivalent to what you just said. I do not advocate what I call the cookie- cutter approach where every medical device is the same. As a biomedical engineer that's not true. Every medical device is different. It might be similar to other devices, but it's different. I must add Jon, as we wrap this up I get a little nervous when somebody preferences something, well, I'm going to give you compliment and I hope it's perceived as a compliment. But anyway, that's very kind of you to say.

Jon Speer: Yeah, absolutely. Folks, my advice to you is reach out to Mike. Vascular Sciences, Mike Drues, he's done countless podcasts with us at Greenlight and webinars. A lot of information, I'll share a couple of those links to things that we've done in the past with Mike. But he's the best in my opinion, regulatory professional in this industry right now. So you should reach out to him and he could certainly help you figure out a creative and legitimate pathway that makes the most sense for your product and technology. So certainly I encourage you to do so. I'm going to remind folks too that of course, Greenlight Guru, we're here to help you as well. We have the only medical device quality management systems software solution on the market today. It was a solution that's designed specifically and only for the medical device industry, and it's been designed by actual medical device professionals. People like myself and our other gurus that are on staff at green light guru. So reach out to us, go to www. greenlight. guru to learn more. We have workflows that help you with your design and development activities, assessing risk and managing your documents and records as well as all the post- market quality events, campus, complaints. It's all in one source. Just like I said I would encourage you to go to www. greenlight. guru. Lastly, to wrap things up today I want to thank you all for being listeners of the Global Medical Device Podcast. Frankly I've lost count of how many episodes, I think we'll quickly be approaching the 200 episode mark probably before the end of the year, or certainly there close to it. So appreciate all of you for listening and continuing to keep this as the number one podcast in the medical device industry. As always, this is your host and founder of Greenlight guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.

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