What "Exempt" Means with Respect to Medical Devices & Regulatory

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed? 

This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.

Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don’t intersect with exemptions, and why some items are exempt.

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Some of the highlights of this episode include:

• The meaning of 510(k) exempt

• Why “exempt” may not be the best word

• What unregulated medical devices are called

• Classifications don’t necessarily mean that a device is exempt

• Comparing and contrasting Class I and Class II

• The difference between general controls and special controls

• Examples of exemptions and why they’re exempt

• The shades of gray in regulation

• The regulatory logic

Links:

Mike Drues LinkedIn

CDRH Website: Class I and Class II Device Exemptions

List of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP Requirements

Webinar: When do we need FDA’s permission to market our device and when do we not? (Nov 2020)

Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)

Webinar: Understanding the Medical Device Classification System (July 2020)

Webinar: General Wellness Devices and Wearables (May, 2018)

Jon Speer LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Mike Drues:

“An exempt device, whether it’s a Class I exempt or a Class II exempt device, it doesn’t matter, is still a regulated medical device.”

“Instead of calling these special controls, we should call them specific controls.”

“One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?”

“What is much much more important than the answer is the logic you use to get the answer.”

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: Hello, and welcome to the Global Medical Device Podcast. This is the founder at Greenlight Guru, Jon Speer. And joining me today is President of Vascular Sciences, Mike Drues. Mike, welcome back to the Global Medical Device Podcast.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience.

Jon Speer: Absolutely. And I got the headphones on today. There's a little bit of home renovation happening in my world, so hopefully the background noise is, well, hopefully nobody hears anything, but if so, you hear a little bit of banging, all is good. We're just putting some new tile in the bathroom.

Mike Drues: The challenges of working from home.

Jon Speer: Yeah. Well, we've all been dealing with that now. I'm guessing most of us have been dealing with that for a couple of years now. I guess it should be routine by now, but there's no such thing as routine when you work out of the house, right?

Mike Drues: Well, as you know, Jon, one of the important regulatory concepts is risk versus benefit. So in terms of working from home, I personally, I've been working from home now for more than 20 years, long before Covid. I think the benefits of working from home far outweigh the risk, but that's just me.

Jon Speer: I tend to agree. I mean, before the Greenlight journey started, I like you worked out of my house most of the time. I mean, of course there's always the need to go to client sites and things like that, but generally speaking, I mean, yeah, working in my own environment, my own desk, my own chair, my own coffee, my own mug. Anyway, I digress.

Mike Drues: And your Greenlight mug.

Jon Speer: There you go. It's a nice one. So folks that are repeat listeners of the Global Medical Device Podcast, I'm sure they've gotten used to you and I talking about important topics with respect to regulatory, but you brought up one that it's fairly obvious to me, although even with that, I suspect that I'm going to learn a fair amount today from our conversation, but I think it's an important topic and generally speaking, the topic is 510( k) exempt. And I'll lay a little bit of a background. I'm sure we'll get into it for sure. But for those of you hopefully listening, you have some familiarity with regulatory pathways. If you've ever pursued getting a device to market in the United States, you will probably have some, at least cursory familiarity with the 510( k) submission. I mean, if you've listened to Mike and I talk in the past, we've described the 510( k) as sort of the workhorse of getting a medical device to market in the US. But there's this term 510( k) exempt that I thought we could dive into a little bit more in depth today. So maybe as we usually do, the first place to start is what does 510( k) exempt mean?

Mike Drues: Yeah, great question, Jon. And once again, thanks very much for the opportunity to have this important discussion with you and your audience because this is one of many questions that I get from my customers all the time. What exactly does 510( k) exempt mean? What is the phrase? First of all, I think the word exempt in this context is not a good word to use, to put it politely because it kind of implies to some people anyway, that it's a medical device that's exempt from all FDA regulation. In other words, it's not a regulated medical device. And just to kind of turn things on you a tiny bit, Jon, what do we call a device that's not a regulated medical device? Any ideas?

Jon Speer: I don't think we call it a medical device.

Mike Drues: Well, actually we do. Maybe it's a bit of a trick question, Jon, and I didn't mean to put you on the spot here. It's what we call a wellness device.

Jon Speer: Wellness, yeah, yeah. Okay.

Mike Drues: It's a device that fits under the wellness exemption. And by the way, for the benefit of our audience, I did a webinar for Greenlight a few years ago, back in March of 2018, specifically on wellness devices and wearable. So if anybody's interested, we can put a link to that webinar from this podcast. But exempt, in my opinion is not a good word here, because as I said it applies to some that it's exempt from all medical device regulation. In other words, it's not regulated by the FDA in any way, shape or form. In other words, it would be a wellness device. And that is absolutely not what exempt means in this context. An exempt device, whether it's a class I exempt or a class II exempt device, it doesn't matter. An exempt device is still a regulated medical device. In other words, it meets the code of federal regulations or the CFR definition of a medical device. And once again, Jon, as a reminder to our audience, I did a webinar for Greenlight back in November of 2020 on what is a medical device and specifically when do you need FDA's permission to market a device and when do you not? The essence of a definition of a medical device, if I take the CFR definition, which is many, many, many paragraphs long, but if I boil that down, the essence of a medical device, the Mike Drue's definition if you will, is something, anything other than a drug that's intended to prevent, diagnose, or treat a disease, injury or condition. So let me just repeat that. That's the essence of a medical device, something, anything, doesn't care if it's a piece of software, if it's a solid object, if it's a liquid, could be anything. It doesn't matter something, anything other than a drug that's intended to prevent diagnose or treat a disease, injury or condition. An exempt device, whether it's class I exempt or class II exempt, it doesn't matter. It's still a regulated medical device. In other words, it's regulated by the FDA. But in the case of, for example, a class I exempt device, it's regulated at a very, very low level. So the most important thing I think for our audience to remember from the first part of our conversation, Jon, is exempt is still a regulated medical device, but it's regulated at a low level. And one last thing, and then Jon, feel free to chime in, exempt in this context means that the device is not subject to formal review by the FDA. In other words, no 510(k), no De Novo, no PMA, no HDE, none of that kind of stuff. You still have to have a quality management system. You still have to have design controls. You still have to have FDA registration and so on and so on. But it's still regulated by FDA as a medical device. I don't know if I did a very good job of explaining that. Jon, maybe you can kind of clean it up a little bit or what questions do you think our audience would have?

Jon Speer: Yeah, I think you are spot on. Well, and I'll put a slight twist on it. I think a lot of times medical device companies, when they're developing a new device, one of the activities that is pretty typical is trying to figure out the pathways. And you and I spoke, I think the last time we spoke actually on the Global Medical Device Podcast, we talked about the importance of regulatory strategy. And so folks, I encourage you to listen to that. So don't confuse regulatory pathway with your strategy, but a component of that strategy is figuring out the different pathways. And once you start to hone in on that, from time to time, you do come across, oh, my product for this indication for use, per these regulations and these particular product codes that seem to be most applicable to my product. You might come across a scenario where that particular code for this kind of product is 510( k) exempt. And I think sometimes when people hear that, they're like, " Cha- ching. Yes. That means I have to do less work." No. And I think Mike's words, well, not with caution, but listen to what he's saying because it just means that there's a slightly different pathway to get to market. It just means in this case that you're not preparing a formal submission for FDA to review. It doesn't mean that you should take shortcuts or cut corners. You still need to do what's important because it is a medical device.

Mike Drues: If I could just amplify just slightly what you just said, Jon, because I think it's a very important point. I'm going to go a little bit further. You said that some people when they find out their device is exempt, 510( k) exempt, for example, " Ka- ching Ka- ching." It means it's easier or less work for them. Well, anybody that thinks that way, quite frankly, and this might sound harsh to some people, they should not be in the-

Jon Speer: Yeah. Get out of the industry.

Mike Drues: Get out of the industry, because unfortunately that's what leads to a litany of problems. But anyway, I didn't mean to interrupt, so please.

Jon Speer: No, I think that's crystal clear to me, and I hope folks hear that too. I mean as med device professionals, we still have the responsibility to make sure that the products that we're designing, developing, manufacturing, selling, managing, maintaining, et cetera, et cetera, are as safe and effective as they can possibly be. And just because you get an exemption doesn't mean you get to pass go with going through all the steps. You still have that responsibility, well, most importantly, to the patient to make sure that you're doing things on the up and up and that sort of thing. So yeah, I agree. If you're not willing to do that, then this might not be the right industry for you. So let's talk a little bit about exemptions are not necessarily classification specific, right? I mean, a device could be classified as class I or class II and could be exempt, but also at the same time, I'm fumbling with the question, let's try it a different way. Just because my device is a certain classification does not necessarily mean it is exempt or not exempt, right?

Mike Drues: Yeah, that's correct, Jon. Whether your device is exempt or not is largely independent of classification. Let me try to phrase the question maybe a slightly different way. So some people will ask me, are all class I medical devices exempt, and similarly are all class II medical devices non- exempt? Well, the short answer to that question, Jon, is absolutely not. By far the vast majority of class I devices are in fact exempt devices. But notice I'm saying the vast majority, not all, there are some, admittedly not many, but there are some class I devices that are non- exempt. So if you have a class I exempt device, that means that no 510( k) or De Novo is required. On the other hand, if you have a class I non- exempt device, that means that a 510( k) or De Novo would be required. So that's all on the class I side of the universe. Now let's jump over to the class II side of the universe. The vast majority of class II devices are non- exempt, meaning that a 510( k) or a De Novo would be required. However, there are some class II devices that are exempt, and we can talk about some examples in a moment. But there are some class II devices that are exempt, meaning that even though it's class II, no 510( k) or De Novo is required. As a matter of fact, Jon, if you go to FDA's website where they talk about class I and class II exempt devices, and we can provide a link to the website with the podcast, there actually is a typo on FDA's website. There is a factually incorrect statement on FDA's website. In the first sentence of the website, it says, and I quote, " Most class I and class II devices are exempt from pre- market notification 510( k) requirements." That is a, if you want to say it politely, typo, if you want to say it, as I say it as a expert witness in medical device product liability cases, a factually incorrect statement. It is absolutely not true. Most class I devices are exempt. Yes, that's true. Most class II devices are non- exempt. And I just find it interesting, I'm not trying to overly beat up on FDA because after all, everybody makes mistakes. But on the other hand, there is some irony, Jon, you know, FDA holds companies very, very closely to what they say in terms of their labeling and their claims and so on. Shouldn't FDA be held to the same level of scrutiny, if you will, on their own website? I'll leave that as a rhetorical question.

Jon Speer: Well, then I'll ask an equally rhetorical question. Fixing that typo does not seem like that requires a significant amount of policy to make sure that the information is factually accurate, but obviously it's still there, so.

Mike Drues: Yes, one would like to think so, Jon, but unfortunately we're talking about our US government here, so nothing is easy.

Jon Speer: Yeah, I'm sure there is, yeah.

Mike Drues: More importantly for our audience, Jon, what's the lesson to be learned here? The lesson to be learned is don't believe everything that you read or that you hear, including what you read on FDA's website. I'm a big fan of the old Ronald Reagan mantra, trust, but verify, right? So I see a lot of people say, " Well, it says this on FDA's website, therefore it must be true." Well, I don't know about you, Jon, but God forbid if you needed surgery, would you want it to be done by somebody who's following some procedure they see on a website somewhere? Probably not. So trust but verify. It's a basic regulatory mantra.

Jon Speer: Yeah. All right. So to kind of recap that part, so most class I devices are exempt. Most class II devices are non- exempt. There are exceptions, of course, so don't accept either of these. Classification is not necessarily the absolute determining factor of what thou shall or what you need to do from a regulatory submission standpoint. So dig in a little bit deeper to try to understand that. Now I guess keeping that in mind, knowing that there are some class II devices that are exempt, some not most, some are exempt, and most class I are exempt. Let's just talk about the exempt devices, class I and class II. How are class I and class II exempt devices the same? How are they different? How can you compare and contrast these?

Mike Drues: Yeah, great question, Jon. So in other words, what's the difference between a class I exempt or a class II exempt device? So obviously classification has a lot to do with it, but as I said a few minutes ago, exemption is really independent. It's related to, but it's also independent of classification. And by the way, Jon, for those in our audience that are interested, I did a webinar for Greenlight back in July of 2020 specifically on the medical device classification system. We can provide a link to that webinar as part of the podcast if anybody's interested. But class I devices, both exempt as well as non- exempt, are subject to what we call general controls. General controls are the most basic kind of controls. They apply to all medical devices across the board, every single, maybe I shouldn't say every single, but the vast majority of regulated medical devices, that is the vast majority of devices that fit the CFR definition of a medical device that I said earlier, they are subject to general control. On the other hand, class II devices, now we're going sort of one level up in my medical device pyramid, as I like to call it. They are still subject to general controls because all regulated devices are subject to general controls. But in addition to the general controls, they are subject to the applicable, what we call special controls. And special controls only apply to certain kinds of medical devices depending on their technology, their mechanism of action, their indications, and so on. So simply put, Jon, the biggest difference between class I exempt, class II exempt devices, which is in fact the same differences between class I and class II devices that are non- exempt is that class I devices are subject to general controls, class II devices are subject to general plus special controls. Does that make sense, Jon?

Jon Speer: I think so, but I think I want to unpack that one a little bit more. So I guess to kind of play back what I've heard you share is that this is sort of building or additive, but every medical device, general controls apply to every device regardless of classification. But as you sort move up or down the pyramid so to speak, there's additional things that become applicable. And so in the case of an exempt device, a class II is going to have something above and beyond just those additional general controls that only applied to the class I. So maybe that would be a great place to start to shift towards is what are the differences between general controls and special controls? Maybe giving some additional explanation there will help us all better understand some context.

Mike Drues: Absolutely, Jon, happy to explain that and I'm happy to provide some examples as well. And by the way, I know I've already mentioned a few of my webinars. Here's one more webinar that I'll mention. I did a webinar for Greenlight just a few months ago, specifically on special controls. So we can provide a link to that for those that are interested. General controls, as I said before, these are the most general, the most basic kinds of regulatory requirements that apply to all regulated medical devices. So examples of general controls would include things like adverse event reporting, device tracking, universal device identification or UDIs, removal and corrective actions of dealing with adulterated and misbranded devices, device registration. Those things apply to medical devices across the board. I don't care what it does, how it works, and so on. So those are the most basic things. One step above that are the special controls. Special controls are special if you will. They typically involve some kind of performance standards, maybe electrical safety, maybe biocompatibility, maybe usability. It might include things like post- market surveillance requirements. It might include the use of patient registries. They might include special labeling requirements. They might include pre- market data requirements. In fact, Jon, FDA has 126 special controls listed on their FDA website. So special controls are one step above the general controls. But I'm just curious, Jon, have you ever thought about this phrase special controls? Why do we call them special? I think this word special in this context is an absolutely terrible term because there's nothing special about these. It's not like everybody shows up, gets a trophy, right? There's nothing special about them. So instead of calling these special controls, we should call them specific. And I think I made a Freudian slip earlier when I mentioned that. It drives me nuts how we still continue to perpetuate this. I can't think of a polite word to describe it, but there's nothing special about these. They become more specific. So if you have a simple class I medical device, and I'll give you some examples in a moment, but a device for example that's not going to come in contact with patients, then biocompatibility is not applicable. If you have a class I device that does not involve any electricity or it doesn't get plugged into the wall, then electrical safety is not relevant to that. Those kinds of requirements would not make sense to impose as general controls because as we've talked about before, general controls apply across the board. But as the class of the device increases, the technology of the device typically becomes more complicated. The indications become more complicated. The pathophysiology oftentimes becomes more complicated. So it makes sense for the regulation as you increase in class not to become more special, but rather to become more specific. And one last thing that I'll mention, Jon, in the context of special controls, which I'll just mention very, very briefly here, special controls are a very significant advantage for anybody that is considering going the De Novo route, a very significant advantage. Because long story short, you can work with FDA to create some new special controls or what I would call specific controls that can act as a barrier to entry to your competition. It's an example, Jon, of something we've talked about before many times what I call competitive regulatory strategy. And for anybody that's interested in that topic, I would invite you to watch the webinar on special controls. Watch my webinar on De Novo, or I think I even did a webinar on competitive regulatory strategies. So special controls are a significant advantage for people doing a De Novo. Does that make sense, Jon? There was a lot in there, but maybe we need to, we could do more.

Jon Speer: So a couple questions. I think you said there's what, 126 special controls?

Mike Drues: The last time I looked on FDA's website, that is correct. Most of those, Jon, are guidance documents. One example of a special control can be a guidance document, but there are other kinds of special controls. They might be industry standards. They might be best practices. They might be lots and lots of different kinds of things.

Jon Speer: The last little bit was intriguing to me. So you and I have talked a fair amount over the years about De Novo and we've done podcasts and I believe you've done at least one, probably multiple webinars on that particular topic. And De Novo, I mean I think a lot of folks used to think, " Oh, De Novo is sort of a kiss of death," so to speak, from a realistic regulatory pathway. And we're not going to get into all this today. But there are some strategic advantages to pursuing that. But that last little bit that you shared is, I want to unpack that a little bit. So what I heard is if I pursue a De Novo, I might have an opportunity to define special controls. Now, not every De Novo defines a special control, I'm guessing, right? Because tell me more about that. That's a little bit intriguing. How does one go about creating their own special control if they are pursuing De Novo?

Mike Drues: Yeah, great question, Jon. And just very briefly, I would modify slightly what you said. You said a manufacturer might have the opportunity to create special controls in a De Novo, scratch the word might, Jon. The manufacturer definitely has an opportunity to work with FDA to impose a new special control or multiple special controls as part of the De Novo. In essence, Jon, what we're talking about here is a successful De Novo results in a new device, obviously, but a new regulation, a new product code being created, and in many cases, new special controls being created. Now a company cannot obviously unilaterally impose special controls on other manufacturers. But what the company can do, and in my opinion it would be a huge mistake in the De Novo not to do this, is to greatly influence FDA on what the special controls should be, not just for their particular device, but for all similar devices coming to the market in the future. And if you design these special controls properly, Jon, and as an R& D engineer when I started out in this business 30 years ago, this is one of the many things that I did. I would design testing methodologies, special controls, if you will, that were favorable to my product that at the same time would make it more difficult for my competitors to match. If we can get the FDA to impose that as a special control, now you have just created a speed bump in the road, if you will, right in front of your competition. So I'm glad you picked up on that, Jon, because it's one of many great examples of what I call competitive regulatory strategy. Not just jumping through the regulatory hoops if you will, but using regulation as a tactical weapon against your competition.

Jon Speer: Right, absolutely. So I think to help continue to provide a little bit of clarity on this, personally I'm a sort of visual learner I think, or there's visual elements that help me learn and grasp a topic a little bit better. And I suspect a lot of listeners might be in that same boat. So what are some examples of some class I exempt devices? And more than just the examples, maybe provide a little bit context from your point of view as to why they are exempt.

Mike Drues: Yeah, great question, Jon. And I really want to focus on that latter part of the question. Not just a certain device is class I exempt or class II exempt, but most importantly why, because one of my frustrations with a lot of folks in this business is they just follow the regulation like a recipe, like a computer executing lines of code one by one without asking, does this make sense? So the why here is just as important if not more important than the what. So let's start out with a very simple medical device, Jon. You said you're a visual learner. I'm not going to put a picture of it up on the screen, but I think you know what this looks like. What class is a scalpel? You know what a scalpel is, obviously, Jon.

Jon Speer: Of course.

Mike Drues: It's a simple device cutting through tissue. So if I were to ask you what class is the scalpel, how would you respond?

Jon Speer: I would respond that it's a class I device.

Mike Drues: Good guess. Is that a guess by the way or?

Jon Speer: Yeah, I was trying to jog my memory. Yeah, it's a guess. It's a guess. I haven't committed to memory classifications of products. Had I been asked that question in a normal context, I would've been like, " Well, my suspicion is class I, but let me verify by reviewing the product codes and regulations to determine specifically." But yeah, that's a guess.

Mike Drues: Well, first of all, I don't want to ask you or anybody to memorize classifications or product codes. That's a complete and utter waste of time. But your answer is partly correct, Jon, but it's also partly incorrect.

Jon Speer: Okay.

Mike Drues: The better answer, and in fact, the best answer to every question in regulatory affairs-

Jon Speer: It depends.

Mike Drues: ...it depends. It depends. So what does it depend on? It depends on what you say in your labeling. So if your intended use of the scalpel is a general indication like cutting tissue, then in fact you are correct. It is a class I device and in fact it's a class I exempt device. But if we change the labeling, the scalpel itself is exactly the same. But if we change the labeling and specifically indicated for corneal incisions used in ophthalmology in the eye, now that same scalpel becomes class III PMA. So let me say that one more time. The classification for a scalpel with a general indication, and this is one of the examples that FDA shares on their website. I know at least they used to. The classification for a scalpel with a general indication of cutting tissue, that's class I exempt. The classification of exactly the same scalpel molecule for molecule, the design is the same, the materials are the same and so on. If the indication is for corneal incisions in the eye, it becomes class III PMA. I don't think it takes an MD or a PhD or RAC after somebody's name, Jon to appreciate that gee, there's a pretty big difference between a class I exempt device and a class III PMA device. A class I exempt, no, 510(k), no De Novo, no nothing. Whereas a class III, you're talking about a PMA or PBE, and then an HDE, simply because of what you say. So there's one example, Jon. Let's take another example. How about a wheelchair? What is the classification of a wheelchair?

Jon Speer: I forgot. I'm out of practice, Mike, that the initial answer to every regulatory question is it depends. And wheelchair, I think definitely it depends because there's so many different options from a wheelchair perspective. So I'm going to say it depends.

Mike Drues: So you are correct, Jon, the right answer, but let's see if you got the right reason. The first example, the scalpel, we said it depends, but there it depended on the labeling. The wheelchair, and I teach part- time, Jon, so I use these examples on purpose. The wheelchair, it depends, but not on the labeling. It depends on something else. Can you imagine what the other thing might be?

Jon Speer: Well, I think the labeling is partially important because I mean you've got wheelchairs that could be used for general convalescence or something of that nature, but there are other wheelchairs that are fully powered electromechanical devices. Some patients need those that have joysticks and they need those for their mobility. So I think in some respects, part of the thing that's influencing that, is it purely mechanical, motor or hand driven or human powered so to speak? Or is it something that has electronics that are driving the wheelchair?

Mike Drues: Kudos to you, Jon, because eventually you did come to the correct answer. It took you a few seconds to get there, but that doesn't matter. Eventually you did come to the correct answer. Yes, it does depend on the labeling, but in this particular case, what is more important is the technology. So bottom line, a manual wheelchair is a class I exempt device, Jon, a manual wheelchair is a class I exempt device. However, a powered wheelchair is a class II non- exempt device. So manual wheelchair is a class I exempt, power wheelchair a class II non- exempt. The question to you and to the audience, Jon, is why? Why is a manual wheelchair class I exempt, whereas a powered wheelchair is class II? And I'll give you a big hint, Jon.

Jon Speer: Special controls.

Mike Drues: The answer we've already talked about. Exactly.

Jon Speer: Yeah, special controls.

Mike Drues: Exactly right. Exactly right. Because the general controls, remember these are the most basic controls. These apply to all medical devices across the board. They would not be special enough or specific enough to ensure the safety and efficacy of a powered wheelchair. Therefore, the regulatory logic is very, very simple. We need to have it class II because class II would give us the opportunity to superimpose those special controls on a powered wheelchair that would not have the option if it was a class I device. The last example for a class I exempt device that I thought I would share with you and your audience, Jon, is a dental curing light. If you go to the dentist and he or she shines light in your mouth, what is the class of a dental light? Do you want to take a guess?

Jon Speer: Dental light. Well, I actually have a little bit of experience with these sorts of lights.

Mike Drues: Good.

Jon Speer: So now I just set myself up to hopefully get the answer right. Well, it's similar to the scalpel example. I think the dental light is class I exempt, if I'm remembering, this has been a few years, and so I'm using old aid as an excuse here if I happen to be wrong. But I know the same light used for other indications, like for ophthalmic purposes changes. But I think for dental, I think it is class I exempt.

Mike Drues: Pretty close, Jon. You almost got all the way across the gold line. Let me see if I can help you out. You're right. It depends on the indication, in other words, what it's being used for. So simply put, there are three different regulations that apply to dental lights depending on exactly what they're being used for. If the indication is for daylight, in other words, dentist is using it just kind of like a flashlight see inside your mouth, or if the indication is for bleaching, in both of those cases, it's a class I exempt device. However, if the indication of exactly the same dental light is for curing, now-

Jon Speer: Oh, that makes sense, yeah.

Mike Drues: ...dental light becomes class II non- exempt and a 510(k) or perhaps a De Novo would be required. So once again, Jon, the light can be exactly the same, just like the scalpel. As a matter of fact, the wavelength, the power, the intensity, all those parameters of the light can be exactly the same. But in some cases, if it's being used for daylight or simply for bleaching, it's class I exempt. If it's being used for curing, it becomes class II non- exempt and a 510(k) or De Novo would be required. So those are just a few examples of class I exempt devices, Jon.

Jon Speer: All right, that helps. And for those keeping score at home, I think I got about a 50% on the Mike Drue's quiz.

Mike Drues: I'm not keeping score, Jon.

Jon Speer: Hopefully there's a curve that I'm being graded against. All right, so now that we have a couple of examples of class I exempt devices, let's do the same sort of exercise. Let's talk about some class II exempt devices. And again, the most important part is the why behind it.

Mike Drues: Yeah, great question, Jon. So first of all, I've already given you a couple of examples of class II exempt in part of the class I exempt options. But here are a couple more. A refrigerator. Is a refrigerator a regulated medical device? Well, most people would think, " Well, gee, if I have a refrigerator in my kitchen storing food, that's obviously not a regulated medical device," and it would not be. But what about a refrigerator that's used to store blood, right? Is a blood refrigerator a regulated medical device? The answer to that question is yes. I'll give you the answer, Jon. You see if you can come up with the explanation. It's a class II exempt device. The question is why is a blood refrigerator a class II exempt device, Jon? And while you're thinking about the answer, let me just remind our audience that the FDA website will always tell you the what. And for example, if you're developing a blood refrigerator, you can easily go to FDA's website and it will tell you a blood refrigerator is class II exempt. But it will rarely ever tell you the why. Why is it class II exempt?

Jon Speer: See this one's confusing to me, and I'll talk through my thought process because it seems like a refrigerator for all intents and purposes, saying that it's a class II exempt almost is saying that a blood refrigerator is more or less the same as the refrigerator that I have in my house. And I know I'm taking a few liberties here, but that refrigerator that I have in my house has a few controls. I mean some of the more sophisticated ones, I can actually specify a certain temperature for that refrigerator. I think about my wine cooler. I've got buttons where I can set the exact temperature of that. I don't know the full range of the refrigerator. But in thinking through that, I'm guessing that a refrigerator, as long as it has a certain upper and lower limit as far as the temperature range is concerned, that must have been demonstrated that the blood has stability at being stored at those temperatures and doesn't have any sort of homolysis or adverse effect on the properties of blood. So that's my conclusion on that.

Mike Drues: Yeah, I think largely your explanation is pretty good, Jon. The answer, first of all, why it's class II and not class I is because we need the special controls necessary-

Jon Speer: Special controls, because you would get temperature, yeah, right.

Mike Drues: Exactly. Correct. To maintain proper temperature range and so on of blood or drugs or whatever it is that you're, you know, plasma that you're storing in there we would not have the opportunity to do that if it was a class I device. Because class I devices are only general controls, not special or specific controls. So that explains why a blood refrigerator is class II, Jon, but it does not explain why it's exempt. So why is a blood refrigerator a class II exempt device? Do you want to guess about that one?

Jon Speer: A couple thoughts. So the special or specific controls, I'm guessing there are special controls that are probably specific to blood refrigerators. There's probably a guidance or something of that nature. And within that guidance it probably defines the upper and lower temperature limits and the power requirements and if there's a backup battery. There's probably all sorts of things that define the criteria for a blood refrigerator. So I think that, and not that blood refrigerators are ubiquitous, but it's a technology that has been around for decades now and it has a proven track record of having some stability, I guess from a device performance perspective. That's my assumption.

Mike Drues: Okay. I think the tail end is where you started to go into the correct direction, Jon. I want to separate the issues here very, very distinctly, because I think it's very important to understand the regulatory logic. The reason why a blood refrigerator is class II and not class I is because of the necessity of the special controls. We've talked about that already. The reason why it's exempt, think about it this way, Jon, if you looked up the product code for blood refrigerators and then you went to FDA's 510( k) database, you will find many 510( k)s for blood refrigerators. However, I just told you that blood refrigerators are a class II exempt device. So how do we explain, how do we rationalize the fact that on one hand it's a 510( k) exempt device, meaning no 510( k) is required and on the other hand, when you go to the 510( k) database, there are a whole slew of 510( k) s for blood refrigerators. The logic is very simple, Jon, once you understand it, and as I said to some of my graduate students the other day, this is stuff that you cannot read in a book. You cannot read it on FDA's website. You have to kind of figure it out yourself. So this is the explanation. Those 510( k)s for blood refrigerators were cleared in the past, but at some point in time, FDA down classified blood refrigerators from class II non- exempt to class II exempt, meaning that today a 510( k) for a blood refrigerator is no longer applicable. And the reason why, a couple of reasons, Jon. First of all, as you started to describe, it's well established technology. Refrigerators have been around for a very long time. The standards are pretty well known and accepted and so on. We understand the risks and the benefits. The regulatory logic is exactly the same as what we use in the drug world. When a drug goes from prescription to over the counter, the regulatory logic is exactly the same. We've used it for a long time, it's got a well- established history of use. We understand the risks and benefits, yada, yada, yada. So the regulatory logic here is exactly the same. The other reason why it's a exempt device, Jon, is more of a pragmatic one because in the world that we live in where we do not have infinite resources and FDA does not have infinite resources, given a choice between evaluating a 510( k) for a blood refrigerator versus evaluating a 510( k) for something else, it's just a better use of FDA's resources to put those resources into evaluating something. So FDA is basically saying, and I think this is a good example, that a 510( k) is no longer necessary for a blood refrigerator for all the reasons that we just talked about. However, it still needs to be a class II device because of the special controls. That's the regulatory logic, Jon. Does that make sense? Do we have time for one more class II exempt example?

Jon Speer: Well, I know we're getting a little long today, so we'll probably need to start working towards wrapping things up. But before we talk about key takeaways and whatnot, I just want to stay on that blood refrigerator example for just one more moment. So I know there are some devices out there that might be considered blood refrigerators, but maybe they're power sources. And I don't know the special controls in place for blood refrigerators, so this could be well defined within those. But if I start to exceed or expand my technology beyond those special controls, I hope this makes sense, but if I'm beyond those special controls that are defined that allow it to be exempt, now I might be non- exempt. I might still have a blood refrigerator, but now my indication or my technology is maybe not as proven or maybe doesn't have that track history as a more standard blood refrigerator.

Mike Drues: That is correct, Jon. If you come up with a new mechanism of action for a refrigerator to store blood, one that does not rely on, I'm not an expert in refrigeration, I think they used to use Freon, but now they use other things. But anyway, if you come up with a totally different way, now you're exactly right, Jon, you're probably non- exempt. But also because you've changed the mechanism of action, you're not looking at a 510( k) anymore, you're probably looking at a De Novo.

Jon Speer: So I think those examples are certainly helpful.

Mike Drues: And that would be an opportunity, that last example, Jon, of a De Novo for a refrigerator because of the new technology. That would be a wonderful opportunity to influence FDA to impose new special controls for the future when somebody wants to come out with a device using your device as a predicate for their 510(k) and you've just imposed this new special control in front of them.

Jon Speer: Absolutely. All right. So I think we've covered a lot of ground. I mean, as I thought I would I've learned a few things myself during this conversation on exempt... I think when you said, " Hey, let's talk about this," in my mind I'm like, " Oh, this is a fairly innocuous black and white topic," but the devil is definitely in the details, as with most things. There's certainly shades of gray within all of this conversation. So I learned a few things, but what else do you think is important as we wrap up the conversation on 510( k) exempt?

Mike Drues: Well, a couple of things, Jon, and again, thank you to you and your audience for having this important discussion. And thank you on a personal note for being willing to play along a little bit here. I didn't mean to put you on the spot.

Jon Speer: It's all good.

Mike Drues: So thank you for chiming in. First of all, Jon, I hope that you would appreciate we've been doing these podcasts now for many years that in the regulatory world, at least to me anyway, there is absolutely nothing that's black and white. There's an infinite number of shades of gray, and it's in those shades of gray that gives us the opportunity to maneuver, to manipulate, if you will, to do what it is that we think is right. So in terms of classification and class I and class II exempt versus non- exempt, I hope we did a good job of explaining some of the pragmatic differences like for example, general controls versus special or specific controls and exactly what exempt means. Exempt means that you still have a regulated medical device, but you do not have a formal review of the device with the agency. In other words, no, 510( k) De Novo, no PMA, nothing like that. You still have to have a quality management system. You still have to design controls, you still have to have FDA registration, all that kind of stuff. But most importantly, Jon, what I've tried to emphasize, not just in today's conversation, but in all of our discussions we've done over the years, is the regulatory logic. It's not enough if somebody says one plus one equals two, you might say, " Gee, that's interesting," but what have you learned? Absolutely nothing. Because what happens tomorrow when somebody asks you, " What is two plus three or five plus seven?" And so on and so on. So what I'm trying to emphasize here is not just the answer. Yeah, the answer is important, but what is much, much more important than the answer is the logic that you use in that answer. So those are a few of the takeaways, Jon. What would you add to the list for our audience?

Jon Speer: No, I like that. I mean, hopefully folks picked up on the conversation Mike and I had today. We thought out loud a little bit and explained some of the steps that one might go through to determine is it this or that, and what does exempt mean and why do special controls apply here and not there and that sort of thing. So just going through that thought process I think is a good thing to do. And I think the other key takeaway is not to sound flip, but whether or not your device is exempt, who cares, right? I mean, of course you care, but at the same time you shouldn't care because it shouldn't be the excuse for cutting corners and it's not a freebie. You don't get to avoid what's important about being a medical device company just because you got an exemption status for your product. It's still important that you understand and apply general controls for each and every and all medical devices and special controls apply when it's specific to your medical device. So that's not, just to understand that this is I think key and important to making safe and effective medical devices.

Mike Drues: I could not agree more. Very well said, Jon. Thank you.

Jon Speer: All right. Well, Mike, I always enjoy these opportunities to connect and talk about interesting topics. I found this topic personally to be very interesting. I think I said, I don't remember if I said at the beginning of the recording, but when you and I were chatting, it seemed like a fairly innocuous topic, but clearly those infinite shades of gray that we need to deal with. So I'm glad we did talk about that.

Mike Drues: You know me, Jon, I have this.

Jon Speer: There's always a twist, I know.

Mike Drues: Something that seems to be simple and straightforward and give it a little twist in order to get those mental juices flowing a little bit.

Jon Speer: No, it's very thought- provoking. And I'm of an age now that who wants to sit around and talk about boring stuff? Let's get our brains working. It's what they're there for, right?

Mike Drues: Who would've thought that talking about such benign products like scalpels, like wheelchairs, like refrigerators, could lead to such an interesting regulatory discussion.

Jon Speer: I know.

Mike Drues: Who would've thought?

Jon Speer: I know. Well, thanks for bringing it to my attention. And folks, thank you for listening to the Global Medical Device Podcast. Certainly if you have questions that are regulatory oriented, you're curious about exemptions and class I and class II regulatory strategy and whatnot, Mike Drues with Vascular Sciences is a guy you should reach out to. So connect with him. I know he is more than willing to listen to your question and do his best to try to lead you in the right direction. And of course, if there's anything I can do to help you as well, feel free to connect with me. And thank you for listening to the Global Medical Device Podcast.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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