#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2

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hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. With me today is Mike Drew. We are continuing an episode from last week.

Last week we talked about prescription versus over the counter medical devices and we covered a lot of the beginning grounds. We covered questions like what is a over the counter device?

Can you provide some examples? And we looked at some, some different potential candidates and strategies that you can take in switching. We won't belabor that. So we're just going to go ahead and dive into this next section.

But I did want to call that out in case you want to kind of get caught up to see where we are now. Go ahead and go check out that last episode if you had a chance.

If you're starting here, encourage you to go listen to that episode and then come listen to this one before I get too far along. Mike, it's great to have you with us today.

How are you doing?

Mike Drues: I'm very well, Eddie, and thank you as always for asking.

Etienne Nichols: So over the counter versus prescription. One of the questions maybe we can start out with is let's, let's just start out with a 510k clear device. If we had a 510k clear device, we want to switch.

It's already a prescription device. We want to go to over the counter. What's required? Does it require a new pre market submission?

Mike Drues: Yeah. Great question, Edien. And first of all, thank you as always for the opportunity to continue this discussion. From our part. One previous discussion you mentioned on a very important topic that I get a lot of questions from my customers about.

So does a switch from prescriptive to OTC status for a device that already has a 510 clearance, does that require a new submission in some way? Another, another 510k or something?

Well, Edian, let me turn it around on you for just a second. What is the shortest, most succinct and also most accurate question to every question in regulatory affairs?

Etienne Nichols: Well, it always depends. But this time it depends. Really depends.

Mike Drues: It depends. So you got it right. It depends. So there's a couple of different scenarios that we consider. First of all, if the prescriptive device is either Class 1 or Class 2 exempt, remember, exempt in this context means that it's still a regulated medical device,

but it's exempt from a formal review of the device by the agency. In other words, no 510 or de novo or PMA or anything like that is required. If it's Class 1 or Class 2 exempt, then obviously no new 510 would be required to add OTC, because that would not make sense.

On the other hand, if it was a prescriptive device, that's class one or class two, that's nonexempt, where either we did a 510 before or possibly a de novo before, then probably, and I underscore the word probably, another submission to the FDA would be necessary.

Again, it kind of depends and maybe we can get into some examples. But generally speaking, for prescriptive to OTC label expansions, remember as we talked about in part one, at the end of the day, that means that we're taking the healthcare provider, the doctor, the surgeon, the nurse, whoever it is,

completely out of the loop. Completely out of the loop. And therefore,

by making it over the counter and removing the hcp, are there any issues of safety and effectiveness related to the device that could change when it's used over the counter by a layperson without the oversight of the healthcare provider?

For example, if you need to change the instructions for use, or what I prefer to call the directions for use, the dfu. The underlining assumption there, of course, is that people never mind healthcare providers, but users like you and I are gonna read the directions before they use the device.

And in the real world, Edienne, that's a huge assumption. And one other thing that I would mention along those lines in terms of the the low level labeling is the potential product liability implications.

We've talked a little bit about product liability in previous discussions. When the directions for use are written specifically for the healthcare provider and now you're adding a new intended user, in this case the patient, you may have to rewrite or sections or some, some sections of your labeling, I.

E. Dumb them down, so to speak. Which means that you might have to do more usability testing. We'll talk more about that in a moment to make sure that your new intended user, somebody that does not have MD or RN after the name, can use your device in a similar fashion as the intended user the MD or RN would use.

Does that make sense?

Etienne Nichols: It makes total sense And I'm just thinking about, just even from a product development or risk management standpoint, when you encounter a device as a layperson, I'm using myself as a layperson,

experiencing those different things that might be okay or might not be okay, then maybe it's not actually a risk, but it actually could lead to a foreseeable risk. And I'll give you a specific example.

I was actually in urgent care not too long ago and they gave me an IV and they left the room. When the IV bag finished, the blood started coming up, the iv, IV catheter.

And I watched that and I thought, is this okay or not? And I sort of, I didn't panic, but I could totally imagine if you left me completely on, I might have done something.

And so I just think of that the nurse came and said, oh, it's fine, we should have gotten this, but no, it's no big deal. And so she had a, she had a level of knowledge that I didn't.

And so I can totally imagine from a product development standpoint, maybe some other things should be even, even obviously an ifu, but knowing that's kind of a last ditch effort in a risk management scenario.

What other. I don't know if I want necessarily suggestions on specifics because we'll have to get into specific devices, but what, what are your thoughts?

Mike Drues: Well, first of all, any thank you for, for sharing your personal experience in, in clinical medicine, we would call that a suboptimal experience,

which is a fancy way of saying that it didn't work. But the regulatory irony of this, any of this, I'm sure you are aware, if that happened during the development and testing of the device by the manufacturer, then FDA would be all over that.

However, in this scenario, because it happened in the hospital, in the ER or the emergency care facility, that would be considered the practice of medicine. So whether or how FDA gets involved with that is sort of an interesting discussion.

But in this particular case, for the engineers in our audience, one could easily envision a scenario where we have a little like a backup or a check valve, kind of like a hemostasis valve that we use in cardiology, that would prevent that from happening.

Obviously, from an engineering perspective, that would be a very easy solution to implement. But for products like that, as you know, these are commodity items, means every fraction of a penny that we add to the cost is, is, is could be detrimental.

Etienne Nichols: Yeah. And so I just look at that example as, okay, there was a medical device professional, and maybe that's not a good example because how many People are giving their themselves IVs at home who don't have medical device or medical experience.

But that's just an idea in my mind. What about when something like that happens? I just use that example. You will need to increase the risk management for those lay people who are going to be using your device.

So what if I were to.

Mike Drues: You definitely should. And this is there may be a.

Etienne Nichols: Little bit of a lag.

Mike Drues: This would be an anticipated or a foreseeable risk. And even if you didn't anticipate it or foresee it in advance, that is prophylactically you should still be able to incorporate that into your risk management plan once you're made aware of it.

So for example, if somebody reported that problem to the manufacturer, now it's no longer a hypothetical risk anymore and you need to do what you can via labeling or design or whatever to mitigate that risk.

And one other thing to mention very quickly Eddie, and about that scenario that you just shared from your personal story, and that is in your case you're fortunate that you were conscious and you noticed that that happened.

If you were, God forbid, laying in the ER unconscious and you didn't know that that happened and somebody didn't come along and check on you in a timely period, you know, God forbid you could have let out during that.

So it's not an insignificant risk.

Etienne Nichols: Yeah. So one of the things I'm curious about is when cause you already mentioned if you're going from a prescription to an over the counter device,

if it's 510k previously, most likely that will be as well. And obviously it depends on the different scenarios under what circumstances would that switch increase the regulatory submission burden for from maybe a 510k to a de novo or, or PMA?

Mike Drues: Yeah. So quick question. So first of all, if you make a significant change in your high level labeling, for example, if you decide to add a new indication along with your new intended user, then almost by definition that will likely kick you out of the 510 universe.

Not always, but most of the time might put you into a de novo if you cannot identify another predicate out there with a similar new indication and depending on the associated with that new NTMA or possibly HDE universe.

But you know, most of the time if we're only changing the intended user and nothing else, then you're probably going to be able to stick within the 510k universe. And even in those situations where you want to make more than just a change to attend to the user.

And I've Got a couple of devices that I'm doing this on right now. My advice to the company is do it as a series of baby steps as base hits.

Instead of a home run where we do the label expansion first and add the new intended user and get that through the FDA and then go back and change the indication or change the technology, the mechanism of action or something like that, which would require another 510 or maybe a de novo or something like that.

Etienne Nichols: Okay, and when it comes to these, these things, especially the, the expansion from, or if you can call it expansion, the change from prescription to over the counter, are there certain.

Well, I guess what are the processes of bringing that novel over the counter, that de novo to market?

Mike Drues: So basically the, the overall process is no different for an OTC device than it is for a prescriptive device. As I said before, if the device is exempt, that means no 510 or de novo.

So it's a moot point. However, in, you know what we're talking about here primarily are devices that are non exempt where a 510 or de novo would be required.

So if your new device, that is the device with the new intended user is still substantially equivalent to the previous version of the device, I.e. without the OTC status,

you can use the 510 if a suitable predicate and a suitable product code exists. However,

if it's not significant,

I'm sorry, not significant risk, what is substantially equivalent? I'm sorry, if it's not substantially equivalent, in other words, there's no suitable predicate or product code, then most likely you'll have to do a de novo.

Specifically for de novos though, you have to look at the probable risks and benefits,

including what are the risks and benefits being used when it's used over the counter by a layperson. And for OTC devices these risks might include misuse of the device, misinterpretation of the labeling by the user.

This is, as we'll talk about in a moment, any and exactly why usability testing is so important for devices that are going to be used by non healthcare professionals and even more important for devices that are going to be used over the counter.

Etienne Nichols: Well, maybe we should just go ahead and talk about that.

When you talk about the usability and human factors,

maybe just expound on that. What are your thoughts on some of those things?

Mike Drues: Yeah, great question. So first of all, obviously we've talked about human factors in various conversations in the past. As I just said a moment ago, human factor or usability testing is important in virtually all Medical device products across the board.

However, I say that usability testing is even more important for devices that are intended to be used by a non healthcare professional, like for example, home use devices. Because you don't have somebody with an MD or RN after their name using it.

You just have a regular person like you or I. And in this particular case, when it comes to over the counter devices,

now we're sort of at the apex of the usability importance pyramid. Why? Because not only do we have the non healthcare provider using the device, but the non healthcare provider user is using the device without any supervision from the healthcare provider provider in any way, shape or form.

Remember the simple way to think of OTC devices. We have taken the healthcare provider completely out of the loop.

And so coming back to your risk management plan, usually if you're doing for example a label expansion from prescriptive to otc, I strongly recommend to my customers that you do that you update or possibly even do a new risk management plan in order to take account the OTC user,

not just the healthcare provider. In terms of design controls. That's, you know, part of what I just said is under the design controls. But we have to mitigate residual risk.

And remember, residual risk is the amount of risk that remains after we try to reduce the risk as much as we can cause we never can completely eliminate it. We have to mitigate the residual risk as much as we can for the intended user.

In this case the non healthcare professional. There might be separate or new risks that are apparent when it's used in, you know, by a lay user. And if the risk, sorry, if the results of the risk analysis indicate that users performing tasks either incorrectly or they, they fail to perform certain tasks,

what we call user errors or use errors, if these could result in serious harms to the patient or the device user, then the manufacturer probably needs. Actually, let me scratch that.

Most likely needs to do the appropriate human factors or usability studies and submit those human factor studies in a submission to the fda. And finally, one last thing on usability, edien and I know you are knowledgeable in this area, so feel free to, to follow up with a follow up question here.

Usability when you're doing additional usability testing for an OTC label expansion, as we've been discussing that human factor testing should not include just label comprehension, label comprehension in this case of the lay user, but it should also include some other things like the choice of when to use the device,

the choice of which device to use. If you go to the doctor and the doctor Says you should use this device or you should use this drug. Then you go to the store and you get that device or that drug and you use it the way that the doctor tells it you to.

But there's no healthcare provider here. So take a benign example, like a blood pressure monitor, for example. Go into CVS or Walgreens or even better on the Internet and you'll probably find dozens, maybe many dozens of different health, different blood pressure monitors.

How does the lay user decide which one to use? And so on and so on. So there's a lot of similarities, but there are some important differences when it comes to usability for devices that are intended to be used by a healthcare provider versus devices that are intended to be used by somebody else.

Etienne Nichols: That's a really good point. And I like, I was actually going to use the same illustration, the blood pressure cuff, because my wife sent me there a few months ago when she was pregnant.

I brought home a wrist and she said, oh, I would have preferred the one around the bicep because they're a little more accurate. I'm like, well, okay, I didn't know that.

Or even a pulse oximeter based on your skin color. You know, that's, that's something not relatively recent in the fda. So those are really good points to bring up when you talk about that.

Human factors testing. I feel like some people think ergonomics, you know, or easy to use, useability for ease of use, but it really is risk management. In my mind. A pediatric surgeon may be very safe with the scalpel put in the hand of my 4 year old and it's suddenly not so.

Mike Drues: Yeah, obviously risk management and usability, they're, they're independent but they're also interdependent on one another. I think it's, this is another reason why obviously I know, Eddie and.

Etienne Nichols: Sorry, go ahead,

timeout for just a second. I apologize for the lag. I think if I turn my video off, I wonder if that will help. I think my Internet, it's my fault.

I'll edit this out. But I'm going to take my turn my video off and hopefully that will help a little bit. So. All right,

I think that's a really good point about risk management, inter. Risk management and human factors being interdependent. But I didn't mean to interrupt you. Go ahead.

Mike Drues: No, I was just going to say. What was I just going to say now? Oh, yeah, obviously, you know, Greenlight, you know's business is primarily around quality management systems and so on and so on, which obviously you all do a very good job at.

But this is why all of the quality management sections, all of the sections in your qms, they need to be connected to one another. And what we're talking about right now, Eddie, and is another example of a connection in this case between usability and risk management.

Etienne Nichols: Absolutely. Yeah, that makes sense. And that traceability is so, so important across, across the whole quality management system.

If we kind of back up a little bit, you, you started to go down the road of looking at human factors and the testing that's required, maybe we'll go one step further with that.

What about the clinical trials of over the counter devices? Are there any specific requirements when it comes to clinical investigations?

Mike Drues: Yeah, once again, great question.

The short answer is there are no specific or new requirements for OTC devices when it comes to clinical trial that wouldn't necessarily apply other devices. However, here are some general things to keep in mind.

Clinical trials for all devices. Now, again to be clear here, Edian, I'm talking about clinical trials specifically for regulatory or FDA purposes. As we've talked about before, there are a lot of reasons why a device company might do a clinical trial that have nothing to do with regulatory or fda,

for example health economics or reimbursement, for example clinical adoption and so on. The trials that I'm talking about here are specifically for FDA or regulatory purposes. So all clinical trials for a device, whether it's prescriptive or OTC, they must comply with the good clinical practices or GCPs.

In other words, you need to have informed consent, you need to have permission of the investigational, I'm sorry, the Institutional Review board or irb. You may or may not need an investigational device exemption, an IE ide, depending on if it's significant risk or non significant risk.

If it's significant risk, you probably do need an ide. If it's not significant risk, you probably don't. And by the way, I've done, I did a webinar for Greenlight specifically on significant versus non significant risks.

So we can point our audience to those resources if they're interested. You need to have final financial disclosure of the clinical investigators and so on. And so, so all of that is under the GCPS for devices, whether it's prescriptive or otc.

The other thing to mention very quickly, Eddie, and that is devices used in all medical device clinical trials, whether they're prescriptive or otc, they're subject to the design controls, meaning you have to have your verification and validation, your V and V done prior to initiating the clinical trial, you need to make sure that you've done the testing according to the FDA consensus standards,

for example biocompatibility, risk analysis, software, electrical safety, all of those kind of, you know, what I call no brainer engineering. You need to do that obviously for a OTC device, just like you would for a prescriptive device.

Why? And the logic is very simple. Because if you're using a device on a patient and there's a problem with biocompatibility, do you think that the patient's body is going to ask, well, is this prescription or over.

Over the counter? Of course not.

Etienne Nichols: Right.

Mike Drues: Either it's going to react or it's not going to react. Right. So all of those things are important and you know, so. So it's not, it's not really a shortcut.

Etienne Nichols: Well, what about real world evidence? If you've got a device that's been on the market for a while with prescription, and I think that's a really good point about the biocompatibility, is that something that you can use from that real world evidence to support this pre market submission?

Mike Drues: Yeah, another great question, Eddie. And the short answer is maybe, you know, it's another. It depends.

First of all, and again, we've done podcasts and I think I did a webinar on this as well, we can point to people at. But if this is truly real world evidence,

then potentially we can use it. And I'll talk more about that in a second. However, if it is not real world evidence, but simply what we call real world data,

then most likely we cannot use it in a label expansion. And just as a quick reminder,

all the information that we collect about a device, post clearance or approval, that would be considered real world data. However, some, in some cases, a lot of that data, to be honest with you Eddie, is **** because it's not reproducible, it's not documented, and so on and so on.

So only that portion of real world data that is reliable and reproducible and documented and so on, that would be considered real world evidence. So the first thing we have to make sure is we're talking about real world evidence, not real world data.

That said, if we do have real world evidence, and that can come from many, many different sources, we can use that information to expand the label to add in this case, the over the counter indication without doing a new randomized controlled trial or RCT or at the very least,

we can use that real world evidence to mitigate the amount of new clinical data that we have to collect. As part of an rct Bottom line, Ed in I am a huge fan of using real world evidence in all submissions, including label expansions to add otc with a couple of caveats.

One is it's gotta be good. It's gotta be real world evidence, not real world data. But assuming that it is, you know, why waste time and money doing a clinical trial to give us information that we already have?

Now again, just one last thing. Cause sometimes I'm misunderstood about this. I wanna be very clear. I'm not advocating taking shortcuts. I'm not advocating not doing a clinical trial when we really should do a clinical trial.

What I'm just simply saying is this. If we need to do a clinical trial to collect new, then terrific. It's just a cost of doing business. But if we do the clinical trial and it's not going to tell us anything more than what we already know, then quite frankly,

what's the point of spending the time and the money doing it?

Etienne Nichols: Yeah, absolutely. And I love that you brought that out about real world evidence versus real world data. That's a. I don't think it's well understood in the industry. Data, just real world evidence just being real world data I.e.

clean data, hygiene and strong justifications for its applicability. I'll throw one thing out here. This is a little bit of a.

Mike Drues: Just one second, one second. Just to, just to add real quick to the comment that you just made. Yes, I agree with you. There's a lot of folks in the industry that are not confused, that are confused with evidence versus data.

Unfortunately there are also a lot of people in FDA that are confused between that difference as well. And just a very, very recent example, just maybe a month ago or a little less, I did a pre sub meeting and we were talking about this and one of the things that FDA said in their written feedback is they want us to give them quality data.

Well, I said to them, my response is twofold. First of all, facetiously as I said, quality data. Quality as opposed to what ****? What are we going to give you crappy data?

But more importantly, I said just so that we're all on the same page and we're shooting at the same target, how in this particular device's case do we define quality data?

Well, they gave me some sort of general kind of high level response, but they really didn't, did not give me specifics. And so it's not just industry that confuses that, but it's FDA as well.

I'm sorry, I didn't Go ahead and continue. I just bring up that exam.

Etienne Nichols: I love that you brought that example up. And I actually am curious. Let's see, there is a. There. There is a guidance document from the fda. I'm trying to remember when it came out on the use of real world evidence to support regulatory decision making.

I'm not sure if that's that you.

Every, you know, no guidance document is perfect. Some are better than others. I don't know if that's one that you. That what your thoughts are on that one, but it seems like that would be a place to look at.

Mike Drues: Yeah, you certainly can. And you know, guidance is always good for people to look at, but it's a starting point, it's not a stopping point. With regard to that particular guidance on RWE that you're just alluding to, Eddie, and I'm intimately familiar with that guidance.

As a matter of fact, I think that one came out, I want to say, about, about four years or so ago. I could be off a little bit. And it may have been updated once since then.

I don't remember. But just as an FYI, your predecessor, John Spear and I did a podcast on that guidance just after it came out. And one of the things that I mentioned is the possibility of using real world evidence for a new submission here in the United States, where the RWE was coming from outside the United States.

Because the term is real world evidence. It is not real U.S. evidence. Well, long story short, a couple of weeks later, I got a call from a senior policymaker at FDA who wanted to talk to me about this because they never considered the possibility of using real world evidence,

not as a label expansion, but for a new approval for a medical device here in the U.S. where the evidence was collected outside the.

Etienne Nichols: U.S. oh, wow, that's. That's very interesting. I. It blows my mind a little bit. But of course, maybe hearing it, you. You feel it seems obvious. I don't know.

Anyway, I'll leave it at that. That's interesting. Okay, well, to move on reminds me.

Mike Drues: Of my professor from, from, from college in, in partial differential equations, he would write something on the board and, and somebody would ask a question, you know, how do you go from step three to step four?

And he said, well, that's obvious or by inspection or. Yeah, well, it might be obvious to him, but it wasn't to me.

Etienne Nichols: Right, right. Well, and it could be the, the amount of travel when I go different places and I see someone who looks like an American, obviously there. The, the. Every geography has slightly different nuances.

But we are becoming a much more global, global world. So anyway, it's interesting. We are indeed, if we go, if we move on a little bit. I'm curious, you mentioned the fda.

What do you think about the best mechanisms for obtaining feedback when it can we use real world data and so on?

Mike Drues: Yeah, very, very good question as well. So once again, if it's non exempt device then there is no submission. So having a and some people ask me that question, by the way,

can we have a or request a pre submission meeting for an exempt device?

And when you think about that, that's sort of an oxymoron because having a pre submission meeting assumes that this meeting is going to happen before the submission. In other words, at some point there's going to be a submission, whereas for an exempt device there is no submission.

So how do you have a meeting before the submission if there is no submission? This is why for many years I've been saying to the FDA that we need to create another form of pre sub where companies can come to the FDA for exempt devices but more importantly for non exempt devices,

then the standard mechanisms of communication between the company and the FDA remain available.

Probably my favorite. And you if you have any doubts whatsoever about the data that you're going to need to support your label expansion in this particular case adding you know, OTC and you likely think that you're going to have to do a new 510, I strongly recommend taking it to the FDA first as a pre submission meeting or a pre sub if for no other reason than it's cheap insurance.

Because there are still so many submissions that are rejected by the FDA today and people are making these very simple, very amateur mistakes.

Most if not all of them can be either greatly mitigated or in some cases eliminated by taking it to the FDA in advance. The one last thing on pre subs, I know we've talked about this a lot,

the pre subs are still optional, they're not required. But as I said I usually recommend them unless it's what I call like a slam dunk 510 but I saw a recent statistic, it was not a MDUFA statistic, but I need to check on this that pre subs are now approaching the 50% mark.

So roughly speaking, almost half of medical device companies for their submissions are taking them to the FDA as a pre sub first. If that's true, and I haven't vetted that statistic yet, but if it is, I think that's terrific.

However, the caveat that I want to put on it is you don't want to just do a pre sub, you want to do a good or successful pre sub. And my definition of a successful pre sub edion is when everybody in the FDA walks out of the room agreeing with me and by that definition most pre subs unfortunately are not successful.

Etienne Nichols: That makes sense. I think that's a great, great example and illustration explanation of all those things.

This is. Feel free. We can cut this if we need to, but I'm curious if you've seen any changes in response time just due to the changes in the layoffs in fta and then maybe this is a topic for another discussion.

Mike Drues: But well since we're having this discussion towards the end of February, obviously things in Washington D.C. are as I said to one of my one of my customers just earlier today and I apologize for my frankness but it's a **** show and nobody seems to be know what is or will happen in the future.

In terms of my personal experience, I can tell you that I have received emails from FDA reviewers who are basically just letting me know that because of all the things that are going on right now and nobody knows, you know what's happening, that you probably can expect some sort of a delay in us getting back to you exactly how much of a delay or whatever,

nobody knows. But but it is having an effect, there's no question about it.

Etienne Nichols: Yeah,

maybe if we were to look at over the counter devices from a I don't know if I'm going to look up for predicate sake, are there different ways to search the FDA's medical devices specifically for over the counter devices?

Mike Drues: Yeah, great question.

The short answer is in some cases yes. For example, if you have an over the counter IVD device, an in vitro diagnostic within the IVD database, there is a over the counter database for IVD home use lab tests and you can do searches in that database for OTC IVD tests.

However, for all other non IVD medical devices,

unfortunately there is no way, at least no way that I know of. If somebody knows of one, please let me know. To go into for example the 510k database or the de novo database or the PMA database or any of the other 18 or so databases that CDRH maintains and tick a box that says only give me OTC devices.

You can't do that for clinical trials. You can do that for submissions that have been completely redacted and are through the Freedom of Information request and so on. But there's no tick box for otc.

So for my FDA friends that are listening out there, I would strongly recommend adding a OTC and or prescriptive tick box to at least the most important databases like 510 de novo and PMA.

I think that would save a lot of people, myself included, a lot of time.

Etienne Nichols: Yeah. Yeah, that makes sense. We'll have to check back with the FDA in a few weeks, see what's, see what's changed here. So if we,

if we go on to maybe a few other, maybe just several questions in one label considerations, disinfection or, or UDI considerations or any, any comments on just any of the specifics when it gets down into the real nitty gritty of those, those aspects.

Mike Drues: Yeah, just very quickly, Elian, when it comes to labeling, first of all, OTC devices are subject to all medical device labeling requirements that are found in the general controls and specifically for otc, this is a statement of the obvious to me.

OTC labeling should be simple. It should be visible, it should be concise, and it should be easily understandable to the lay user. In other words, not to somebody that necessarily went to nursing school or to medical school or to pharmacy school, but the lay user.

You can include not just narratives, that is text. You can include pictures. I also love to include videos. You're familiar with the adage Eddie and a picture's worth a thousand words, but a video is worth a thousand pictures.

And I think a lot of companies should think about that. The labeling should also include the contraindications, if any, to explain when and why an individual, again, a lay user should not use this device and it should include clear warnings of all the hazards.

And the labeling should also be accessible to users, even when the device may become separated from the labeling. If it's printed labeling, for example, the labeling should be accessible maybe on the company's website or through calling the manufacturer.

This should be for prescriptive devices as well, but especially for OTC devices.

When it comes to cleaning or disinfection considerations for OTC devices, once again, the intended user here is the non healthcare professional. So they might not have access to cleaning and disinfection supplies that are available in healthcare care facilities, in hospitals or clinics or doctor's offices.

Therefore, OTC devices need to be able to be cleaned by laypeople in their home. They need to be designed to be cleaned. A classic example of this is the duodenoscope fiasco that happened several years ago where a number of people at UCLA and others died because these devices were not cleaned properly.

One of the root causes of that problem were these devices were clearly not designed to be cleaned or reprocessed. And in those cases they were supposed to be reprocessed by a trained user.

For OTC devices, it's just being cleaned by Joe Schmo. So you really need to make sure that Joe Schmo can clean them properly using readily available supplies that they have in their home already without, you know, some, you know, fancy schmancy solutions that you would only find in a hospital using relatively simple techniques.

And by the way, the reprocessing guidance says that your reprocessing procedure needs to be validated, but it doesn't go on to say who does the validation. And this is a big problem, not just for prescriptive devices, because sometimes I see the medical device company validating the reprocessing procedure when it's not the device company that's going to be doing the reprocessing,

it's going to be the people in the hospital or the commercial reprocessing lab that are going to be doing it. And just because the medical device engineer can do it doesn't mean that the person in the reprocessing lab could do it.

Well, the same logic applies here to over the counter devices. Just because this might be able to be reprocessed sufficiently by a trained professional doesn't necessarily mean that a lay user will be able to reprocess their device sufficiently.

And so all of these things should be incorporated. We talked a little bit earlier, Eddie, under the design controls and risk management, all of these things need to be added, or at least consider adding in your risk management plan.

For example, what are the potential harms associated with a professional user not reprocessing the device properly? And what new or additional or different harms might there be when a late user reprocesses it?

So all of these are, you know, they're subtle nuances here. And then the last thing that you mentioned is in terms of UDIs or unique device identifiers. It's obviously it's a very important and challenging topic for all devices, including OTC devices.

I think in the first discussion at IAN, we talked a tiny little bit about CGMs, continuous glucose monitors. Well, one of the big recalls there was a Class 1 recall because of a problem with the sensor.

If we don't know specifically which devices that are affected and who has them, I. E. Udis, then you know, it's very hard for us to fix the problem and if necessary to get those devices back.

But in terms specifically of UDI and regulation,

There are no UDI regulations that are specific to OTC devices that don't already apply to prescriptive devices.

Etienne Nichols: Okay, okay. No, that makes sense. And yeah, UDI is a hairy monster in and of itself. I used to know the first several digits and what they meant, whether it's. But it's been a while, that's that.

And it's been. It's ever moving. What about some other specific areas like digital health solutions, software regulated as devices, what when are over the counter digital health solutions and software?

When would we need to think about those as devices?

Mike Drues: So specifically with regard to digital health,

it astounds me to this day in: 2025

So there's nothing here in terms of regulatory logic, there's nothing here at all that is unique to OTC devices that doesn't already apply to prescriptive devices. All of this comes down to one simple or perhaps not so simple question.

And that is what is the definition of a regulated medical device? And once again, not to be self serving, but for the benefit of the audience, I did a green light pod, I'm sorry, a greenlight webinar specifically on what is and what is not a regulated medical device.

as a lot of people think. In: 2016

They include software functions for maintaining or encouraging a healthy lifestyle that are unrelated to diagnosis, cure, mitigation, prevention, treatment, so on and so on. These are usually referred to as general wellness devices, which once again, I did a webinar on that as well.

They also included software intended for general patient education.

They excluded software that facilitates patient access to commonly used reference information. For example, reference information that you might find in a textbook or in a library or perhaps even on a, on a website like, I don't know, like NIH or WebMD or something like that.

And finally, they excluded software that's intended to provide patients with relatively simple tools to organize and track their health, information that don't otherwise acquire or process or analyze these. Now this, you have to be a little bit careful because now you're getting close to the area of what we call clinical decision support software.

And as I did a podcast with, I think your Predecessor John Spear. A couple of years ago, when that guidance came out, FDA basically said when it comes to clinical decision support software, that this is, that these are regulated medical devices.

In other words, they fit the CFR definition of a regulated medical device. However, at this point in time, and this was as of a couple of years ago, with that guidance, FDA is choosing to use their enforcement discretion and not to regulate certain types of clinical decision support software.

So. But that could change, kind of like in vitro diagnostics. That could change at any time.

In addition to that, FDA has announced guidance documents that basically say that they don't intend to enforce certain software functions, for example, that provide or facilitate supplemental care, clinical care, by coaching or prompting, or helping patients manage their health, and so on and so on.

This stuff gets very, very blurry, Ed Ian. But if you're working in an area where it's kind of gray and you're not sure, you might want to seek out not just me, obviously, there's other people that you could talk to to get some clarity on this because it's easy to make mistakes and sometimes those mistakes can be very time consuming and expensive.

Etienne Nichols: Yeah. Well, what's interesting to me is that when you, when you talk about all these things, you're talking about devices in general, because there's really, when you, some people make the distinction, software is a medical device versus medical device.

But really software as a medical device has medical device in it. So the regulatory logic really applies to both, so.

Mike Drues: Correct. And if you want to go even one half step further in that direction, there are what we call, or I should say what FDA calls. I don't really like this, this phrase multifunction devices, where certain parts of the product are regulated medical devices and certain parts are not regulated medical devices,

all in the same box, so to speak. And again, FDA put out a guidance on that a couple of years ago, and I'm pretty sure that John and I talked about that guidance as well.

Etienne Nichols: Yeah. Okay. Yeah. Well, I know we're coming up on the end of our time, covered a lot of ground. I'm curious if there's anything that you feel like we left out that, that, that was worth mentioning.

Mike Drues: Well, obviously, you know, we, we devoted two sessions to this very important topic and I'm, and I'm really glad that we did because it gave us an opportunity to get to, to do a deeper dive into several of the topics that we talked about.

We still have not hit the bottom of the ocean, however, but I think we, we, we, we definitely got well below the surface so just I'm not going to add any new information to wrap this up.

I'm simply going to reiterate what I think are a couple of the more important points to remember or common themes from part one and part two. And then as always, Eddie, and feel free to add whatever you think is important as well.

First of all, remember, for a prescriptive device, the intended user is the healthcare provider. It may or may not include the patient.

However,

for an OTC device, the intended user may only be the patient. Now, it's important to understand that the vast majority of devices that are OTC now, just like drugs, they started out as prescriptive and then they went OTC later.

So in that particular case, the intended user is both the ACP as well as the patient. However, now we have more and more devices that were never intended to be prescriptive devices and are now only intended to be used by the patient or the caregiver.

In that case, then it's not the healthcare provider, it's only the patient that's the intended user. And perhaps most importantly and most simply is when we talk about the primary difference between OTC versus prescriptive devices, the way I sort of like to summarize that is with an OTC device,

we are taking the healthcare professional totally, completely and utterly out of the loop. Obviously, the patient could ask the doctor, you know, before using a OTC device, but they don't have to.

And so we have to take that into account in our labeling, we have to take that into account in our design controls, in our risk management and our usability in all of those things.

And ask ourselves for all of the things, all of the testing that we did in order to get this device onto the market for a healthcare provider,

which of these things have the potential to change, for example, create new or additional questions of safety, efficacy, performance and so on when they're used by a late user as opposed to a healthcare professional.

I know these things sound kind of commonsensical and I think, to be honest with you, Eddie, and they are 100% common sense to me because I think all good regulation should be common sense.

And if the regulation does not make sense, it shouldn't be regulation. Is that over naive, Eddie?

Etienne Nichols: Yeah, I can see where you come from and I think just to echo what you're saying, I think regulatory strategy really needs to match your business strategy. I mean, they should, should blend at some point if you want to launch an over the counter, but your risk profile doesn't support it.

Forcing an OTC pathway. I mean, some devices belong in professional hands, so just the, the risk matters. I guess I'll just echo that.

This is really good. I really appreciate it, Mike. I appreciate your willingness to spend this much time on a topic and to, to, to cover all of the different aspects that we covered.

It's really the OTC versus prescription has kind of been a proxy to talk about a lot of different things and hopefully no one noticed that. But I think it's really powerful when we're able to do that.

To take this almost as an example, to really apply a lot of logic across the landscape. So it's good.

Mike Drues: You're welcome. Happy to participate. And as I said me, you know, with Greenlight, you know, we have dug into some of these individual topics that you just mentioned in much more detail than we did in this two parter.

So I would encourage the audience to check out those resources if, if it's relevant to you. And if you can't find them, just send me an email. I'd be happy to help however I can.

Etienne Nichols: Yeah, we'll try to put those links in the show notes so those of you who are listening, feel free to check that out. Send us a comment on LinkedIn or direct email.

Podcastreenlight guru. We'll have Mike's email in the show notes as well, so you can reach out to either of us. We'd love to hear your feedback on this topic. Love to hear more about the topics that you'd like to hear about.

So if you want to reach out, we'd love to hear that. For now, we'll let you get back to it, Mike and those of you who've been listening, thank you so much.

We will see you all next time. Everybody take care.

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