Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.

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Some highlights of this episode include:

• EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.

• The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.

• The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.

• Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don’t work? Both the regulatory and quality burden is higher for companies in the medical device industry.

• Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. 

• Don’t waste the FDA’s time. The EUA needs to be a part of a company’s overall regulatory strategy to determine how it fits into the bigger picture.

Links:

FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Webinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

The End of EUA Is Coming Soon

FDA - Medical Device Overview

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from THIS EPISODE:

“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there’s things that you should be doing and frankly you should have already been doing them.” Jon Speer

 “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues

 “Basically, it’s a very, very special kind of pathway. It is not an approval. It is not a clearance. It’s an authorization.” Mike Drues

 “If you’re not building a plan, a strategy, and starting to execute that strategy, you’re going to be leaving the market with your products.” Jon Speer

Transcription

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: This episode of the Global Medical Device podcast, I catch up with Mike Drues with Vascular Sciences, and we talked about EUA. And I guess the reason we chose that particular topic, FDA recently came out with a couple of new draft guidances describing transition plans, such time when EUA termination has been announced. And we don't know when that is right now and we'll know when the announcement is made, I'm quite sure, but nonetheless, the reason we wanted to do this podcast is for those of you that have products that went through EUA pathway to get to market, there's things that if you want to keep those products in the market post EUA, there's things that you should be doing. And frankly, you should have already been doing them should. You should be proactive. You shouldn't be waiting until you get an announcement from FDA that says it's going to end on such and such a date. Yes, those transition guidances are helpful sort of, as far as laying out steps and processes and details and that sort of thing. But frankly, a lot of this is really about having a good strategy for your business, a good regulatory strategy, a good transition plan, and there's things you should be doing now. So I hope you enjoy this episode of the Global Medical Device podcast. Hello and welcome to the Global Medical Device podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me today is of course a familiar voice and familiar face on the Global Medical Device podcast, Mike Drues with Vascular Sciences. So Mike, welcome.

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

Jon Speer: Happy holidays. I suspect this will be a new year post, so Happy New Years to all of those listening. Hopefully 2021 was a great year and hopefully 2022 gets off to a great start for all of you. But Mike, you said something to me recently, and I think it's timely. And we like to talk about things that are sort of timely and relevant and the topic is really about FDA EUA. Yes, you and I have talked a little bit about that before, but FDA's come out with a couple of draft guidance documents, and we'll get into that here in a moment about transitioning, I guess, away from EUA. But before we get into that, a great place to start, can you remind folks, what is EUA? When do you use it? Maybe a quick overview of that.

Mike Drues: Yeah, great question, Jon. And as always, thanks for the opportunity to have this very important discussion with you and your audience. Just a reminder, a friendly reminder, Jon, you mentioned that you and I have talked about this before. In fact, we did a podcast on this and I did a webinar on EUA, the emergent authorization, for Greenlight back in April of 2020.

Jon Speer: Yeah.

Mike Drues: And the reason why I wanted to just point that out, not to toot my own horn, but that was literally at the beginning of COVID. COVID, depending on who you ask, began roughly about February or March of that year. And we did our first podcast and I did my first webinar on the EUA in April. Since then, of course, lots of people have jumped on the bandwagon, but I just wanted to point out that you and I, we talk about things oftentimes long before everybody else does.

Jon Speer: That's true.

Mike Drues: So as a reminder to the audience, the Emergency Use Authorization, or EUA, is one of the many pathways to market that me device companies can use to bring devices onto the market here in the U. S. Specifically the EUA, and I'll just read a portion of the regulation to you, Jon, it may allow for unapproved medical products or unapproved uses of approved medical products to be used in an emergency situation to diagnose, treat or prevent a serious or life- threatening disease or condition, like COVID for example, when there's no other adequate approved or available alternative that exists. And so basically it's a very, very special pathway. It is not an approval. It is not a clearance. It's an authorization and that's going to have important ramifications as we continue our discussion. Prior to COVID, the drug and the biotech industry have been the primary users of the EUA coming out with vaccines for anthrax and Ebola and Zika virus and a few others. But it really wasn't until COVID that the medical device industry really started using EUAs. And in the last two years or so, since the pandemic has been going on, FDA has authorized more than 800 EUAs for medical devices for COVID specific indication. As I'm sure you're aware, Jon, and people hear about them in press, COVID tests and future diagnostic tests, for example, PPEs, personal protective equipment, as well as ventilators and respirators and let's not forget, of course, the COVID vaccines that are now available. These are all on the market today under the Emergency Use Authorization, or EUA. And one final reminder, just as we sort of give the audience a recap of the basics of the EUA, EUA 101 so to speak, the regulatory burden for an EUA, whether it's for a medical device or a vaccine, the regulatory burden is lower than it is for a traditional approval, for example, a 510( K) or De Novo or PMA or on the drug or biologic side of the world, an NDA and just to illustrate, I'll read a small portion from a typical EUA letter. It says, and I'm quoting," The device," whichever the device that we're talking about here," when labeled consistently with the labeling authorized by FDA is authorized to be distributed under this EUA, despite the fact that it does not meet requirements otherwise required by applicable federal law." Let me read that last part again. They are granting into EUA despite the fact that it does not meet the requirements otherwise required by applicable federal law and in the same boiler plate letter that pretty much every company gets when they get an EUA authorization" it goes on to say in justification," Based on the totality of the scientific evidence available to the FDA, that it is reasonable to believe that the device may be effective for emergency use in treating patients for," whatever it's indicated for," during the COVID pandemic, when used consistently within the scope of the authorization letter." The reason why I bring that up, Jon, is I know there's some regulatory verbiage here, but it's a point of great frustration to me when I hear politicians on the TV, or even sometimes people coming from FDA on the TV saying that the products that are coming onto the market are just as safe and effective, they meet the normal FDA requirements, when that is factually incorrect. And I'm not suggesting that this is a problem. On the contrary, the justification is something is better than nothing. We have a pandemic, so putting these products onto the market in the short- term is the benefits probably outweigh the risk. But to say that these products meet the normal regulatory requirements, I'm sorry, Jon, maybe it's just me, but that is a factually incorrect statement and that does have ramifications when we get to the topic of today's discussion, Jon. And that is if a device company has a device on the market today under the EUA and they want to keep it on the market after the pandemic is over, what are they going to have to do to keep it on the market when that EUA expires? So I know Jon, I went through an awful lot of stuff, including some regulatory gobbledygook. I'm sure it was probably not clear to you or your audience. How would you like to dig into any of what I just mentioned?

Jon Speer: No, it was pretty clear and well, we don't have the benefit to getting real time audience feedback in the moment, but that point you made about assertion that is often made in the media about these EUA products being just as safe and effective and so on and so forth as quote" normal medical devices", I think, is important. I mean, it could be, but that's not the barrier to entry, so to speak. The burden of proof is not that from an EUA perspective. It's a completely different mechanism and process versus a more standard, traditional regulatory type of submission, whether that be a 510( K) or De Novo or a PMA, so very different processes for sure. And I think that's important to understand, because we've seen this at Greenlight, we've been contacted in the past couple of years by, I don't know, easily dozens, probably hundreds, I don't have the actual statistics, of companies who were pursuing EUA products. Some of which were already medical device companies, many of which were not medical device companies. And I think that that's created some challenges, I guess. We'll just leave it a little vague so to speak, but it's going to be interesting. I mean, you sent over a couple links to some draft guidances. FDA has already started to socialize, I guess, transition plans for whenever we're out of this pandemic and out of this EUA state. Do we know when that EUA process, I think the terminology that you used, EUA termination date, has that been publicly stated as," It's going to be on this date." Do we know that yet?

Mike Drues: Yeah. Great question, Jon. First of all, and again, I just have to remind our audience that this is something that I tried to stress even in the webinar that I did back in April of last year, because this to me is nothing new. Remember I said a moment ago, the EUA is an authorization. It is not a clearance or approval. It's an authorization and it is a temporary authorization. Let me read one more line from a typical EUA letter because FDA makes it very clear. It says," This EUA will cease to be effective when the HHS," that's the Health and Human Services," declaration that circumstances exist to justify the EUA is terminated." So all of these things will go away, eventually. The question is how soon? One of the things that I said at the very beginning of COVID was I think a reasonable expectation is to give companies about a six month notice when the EUA is going to be terminated. And in fact, that's now what FDA is proposing, to give companies a six month notification. And by the way, Jon, one thing that FDA did not point out, but I think is a reasonable assumption, is why should all EUAs be terminated at the same time? That to me, makes absolutely no sense. I think what would make more sense is terminate, for example, COVID diagnostic EUAs at one point, terminate ventilator EUAs at another point, terminate PPE EUAs at a third date and so on. It's going to be contingent on the medical necessity of that particular product, not the overall EUA process.

Jon Speer: Because all those EUAs, I mean, just those few examples that you mentioned, they all have very different indications or intended uses. So yeah, let's apply some logic to the decision. That makes a little bit of sense, although I just said regulatory, so...

Mike Drues: Well, I was just going to point out, I always try to, as a biomedical engineer, Jon, apply logic. It's what I call regulatory logic. Whether the rest of the world, including my many friends at FDA, subscribe to that same theory of that same school of regulatory logic, I'm not always sure. But here's the thing, you asked me originally, the question, specific day. Quite frankly, that's purely a political decision and this is something that I said back in that webinar as well. It is when the Secretary of Health and Human Services declares this pandemic to be over. That is purely a political decision. And while you and I can certainly speculate as to when that might be, next January 1st or whatever it is, it is 100% speculation. Much more important to me, Jon, and this is the advice that I've been giving to my customers since the very beginning of COVID, this has not changed one word and that is if you have a product that's on the market... Oh, let me take a step back for a second. If you have a product that was on the market prior to COVID, in other words, you had a device on the market under a 510( K) or a De Novo or a PMA, and you got an EUA for it by adding a COVID specific indication, then you pretty much don't have anything to worry about because your product is going to be able to remain on the market. However, if you have a product on the market that is only on the market because of an EUA and doesn't have a 510( K) or De Novo or PMA or something else, and you plan to continue to have that product on the market after the pandemic, after the EUA has expired, you better darn well start getting your ducks in a row right now. I would not wait for any six month warning or anything else from FDA because I think, to be a bit kind here, I think it's interesting that FDA is planning on giving many companies a six month warning. The underlining assumption there is that they're going to be able to get a 510( K) or a De Novo within that six month period of time. I don't know about you, Jon, but that's a pretty optimistic estimate.

Jon Speer: Just to unpack that a little bit. A typical year, my memory's a little fuzzy. I know you know these statistics oftentimes better than I do. But if I recall in a typical year, FDA reviews something like, it's less than 1,000 510( K) s, if memory serves. Is that right?

Mike Drues: Actually, no, Jon. It's actually a little higher than that. It's typically around three or 4, 000 510(K).

Jon Speer: Okay. Three or 4, 000. All right. Regardless, we're talking about you said 800 devices have received the EUA during the pandemic. That would represent a pretty substantial percentage of normal volume of FDA's workload for 510( K) s. Eight hundred versus a few thousand, I mean, that's a pretty large percentage.

Mike Drues: Well, it might Jon, but we have to be a little bit careful with our numbers here to do an apples to apples comparison because I can't give you specific statistics. I'm not even sure if there are specific statistics under MDUFA. I would love to see them if anybody has seen something. But at least in my personal experience, Jon, the vast majority of EUA devices are not in fact new devices. In other words, these devices were already on the market prior to COVID like a ventilator, for example. You might have a ventilator on the market for whatever indications and then the company decides they want to specifically advertise it for COVID, that in most cases would require an EUA. But if the company, once that EUA times out, as I said before, that company can continue to have that device on the market. If they want to add as a label expansion to their 510(K) or whatever it is, a COVID indication, they can certainly do that. So the majority of devices I don't think are going to require a brand spanking new 510( K) or De Novo, or if they do, it's just simply going to be a label expansion. But a small number of devices, those devices that have EUAs that are not on the market for something else, those are the devices that are going to be most affected here. And to be honest with you, Jon, if the companies that have products like that in that category that I'm just describing, if they sit around and wait for FDA to tell them what day to do this, they're-

Jon Speer: It'll be too late. I mean, of course there's no absolute here, but whenever a company asks some high level advice on the amount of time that one should expect from start to finish to get a 510( K) cleared from the moment that you submit, I'm like usually it's... You should plan on probably about six to nine months. I mean, there are exceptions to that, for sure. But yeah, let's just hypothetically say FDA says the EUA termination date is, and I'm making this up folks, I don't know this, January 1, 2022, then that would imply by July 1, 2022 that companies need to get their products through the FDA submission process and approved and cleared or whatever the appropriate verb there is in that case. And that's just not enough time.

Mike Drues: Yeah. And I would say Jon, for the benefit of our audience, I would take all the dates that Jon just mentioned with a huge grain of salt. I would put them in the same category as the numbers of days that you see in guidance documents. I would take those with a huge grain of salt because FDA will say, for example, we intend to respond within 60 days or 120 days or whatever it is. They don't say that they will. So bottom line, I would be proactive in this regard, not reactive. And more importantly, Jon, just to show you and our audience that maybe the end of COVID, at least in the regulatory or the EUA sense, is closer than some people might think. There is evidence of this even right now. For example, I have a couple of devices that very recently have gone to FDA with EUAs that have been denied because those particular categories have now been deprioritized by the agency. In other words, I have one device in particular, it is a COVID diagnostic device, and basically FDA has deprioritized it basically saying," Hey, we've already got a bunch of these. This is not a priority for us anymore." Although it's interesting in this particular example, Jon, as you probably know the vast majority of COVID diagnostics are either immuno- diagnostics or molecular diagnostics. In other words, they either... On the immunology side, they look for an antigen or an antibody related to COVID or on the molecular diagnostic side, like a PCR, a polymerase chain reaction test, where you're looking for either a gene or a specific sequence of As, Ts, Gs and Cs that's specific to the COVID virus or the capsid of the COVID virus. Well, the interesting thing about this particular device that was just prioritized, Jon, was that it works in a totally different mechanism of action. It is not a immuno- diagnostic nor is it a molecular diagnostic. It is a totally different mechanism of action. Obviously, I'm not going to get into the details of it, but basically FDA has lumped it in with the other molecular diagnostics basically saying that it's not a priority anymore. And now the company is thinking how should the company push back on the agency? Because they're basically saying, well, you should consider doing this as a De Novo. Well, we can do it as a De Novo and we, in the long term strategy, is to bring that product onto the market for the long term as a De Novo. But let's be honest, Jon, that's going to take a year or probably more so what good is getting a COVID diagnostic onto the market a year and a half from now when the immediate need is right now? Our President, just days ago, just said that there's still an unmet need for COVID diagnostics. And yet at least in certain situations, Jon, FDA is deprioritizing certain COVID diagnostics. That doesn't make any sense to me.

Jon Speer: It doesn't make a lot of sense to me either. I don't watch a ton of news, but heard the announcement that I think the government was going to purchase something like 500 million COVID tests or something of that nature and distribute those to people. But then they're like," Oh, but those won't be available until February or March." And everyone else who needs these at home diagnostics, the lines are terrible and there's not enough tests or there's nothing on the shelf and that sort of thing. So it does seem a little interesting, but nonetheless-

Mike Drues: And the other thing that I would, I was just going to say, Jon, the other thing that's interesting, potentially problematic about the EUA, I said earlier, it clearly has a lower regulatory burden than a traditional clearance or approval. It also has a lower manufacturing or quality burden as a traditional 510( K) or De Novo. And I'll just read one more sentence from a typical EUA authorization letter, and I would love to hear your thoughts on this, Jon, as a quality guy. The letter says," FDA is waving applicable CGMP requirements, including quality system requirements with respect to the design, manufacturer, packaging, labeling, storage and distribution of the authorized medical device under the EUA." My question to you, Jon, is this a good thing or is this a bad thing? We've already had examples in the past. For example, in the LA Times, it was reported early in COVID that there were 170 ventilators that shipped to hospitals that were either broken or defective or did not work in some way. So here's my question to you, as well as to our audience, Jon. What is worse? Not having enough ventilators or not having enough diagnostic tests or having a bunch of ventilators or diagnostic tests that don't work very well? And then the other thing that our audience has to keep in mind is when they transition from an EUA to say a 510( K) or De Novo kind of a product, not only are the regulatory burden going to be higher to get the 510( K) or the De Novo, but the quality burden also going to be high. It's going to revert back to what it would be normally without the EUA, without the COVID. So do you see this as a potential challenge for our industry and the companies in them, Jon?

Jon Speer: Well, short answer, yes. Longer answer, I remember when I first read that statement about quality and GMPs and that sort of thing basically being waived, it was a head scratcher to me because that implies that manufacturing a medical device and the inherent quality that one would expect from a medical device is too burdensome. I mean that could be an interpretation. And I don't view that as burdensome. I mean, I look at my role as a medical device professional, I have an impact. What I do has an impact on the quality of life and the devices that I'm involved with certainly have an impact on that quality of life. I want it to be a positive impact, so I always question that. Why should the GMP criteria be lifted for something that is essentially performing as a medical device, granted the-

Mike Drues: Well, why indeed, Jon. I think the justification, it's similar on the regulatory side, it's similar to the whole justification of the EUA and that is we're not living in" normal times" with the COVID pandemic emergency certain shortcuts, and for the lack of a better term, I will use the word shortcuts, certain shortcuts are justified. And I have no problem with that in the short term, but in the long term, not so much. And I would like to think, Jon, and I think that you would probably agree with me on this, that the basic regulatory principles and the basic quality principles would apply across the board, whether we're talking about in a healthcare emergency or not. Would you agree with that Jon?

Jon Speer: A hundred percent and it's a little bit armchair quarterback and very much after the fact. I would've rather have seen FDA put some language into the initial COVID regulations, I guess that's the right word, that maybe waved it temporarily, but requested maybe as part of an EUA that the company provide a plan as to when they would be able to address certain things like GMPs and that sort of thing. But like I said, it's armchair quarterback. It's a moo point.

Mike Drues: And let me give you a perfect example, Jon, because I think that this is going to be a wake up call-

Jon Speer: I think so too.

Mike Drues: For certain players in our industry. I have a new customer that's just come to me recently. They're in the category of device where they have a device on the market now under an EUA. They do not have 510( K) for it yet. They did a pre- sub meeting with the FDA in anticipation of getting their 510( K) or their De Novo. It's still not exactly clear which pathway that we're going to take yet. And they did all that prior to working with me. But they came to me because they were genuinely surprised. The response that they got from FDA with the pre- sub is, Hey, the data that you gave us for the original EUA was sufficient for the EUA. It is not sufficient for a 510( K) or a De Novo. And basically that was a big, how do you want to say, eyeopener for the company, Jon. They thought, to use a regulatory pun here, they thought that they were going to be able to essentially provide the same information, information that was substantially equivalent to the information that they provided in the original EUA. And I told them, hey, you don't have to tell me any more details than that. But what I can tell you with a hundred percent certainty is that the regulatory burden and similarly on the quality side, the quality burden is higher for additional medical device than for a COVID/EUA medical device. And one other thing that I would mention, Jon, on the post- market surveillance side, the requirements for an EUA for post- market surveillance have been relaxed compared to what they would be for a non EUA device, which begs the question. A lot of companies are thinking about using some of their post- market surveillance information, if they have any, as real world evidence to support their 510( K) or especially their De Novo. I love that suggestion, Jon. As you know, I'm a big fan of using real world evidence, but remember the requirements for collecting that information during COVID are not nearly as stringent as they are for non- COVID devices. So whether that's going to be an option for many companies in the immediate future, time will tell.

Jon Speer: Man, we could go on and on about all of that. But in the interest of, I guess, providing insights and helpful tips and pointers to companies that may be in this EUA situation with their products, I mean, the fact that the FDA has published two draft guidances about the transition from COVID and EUA, should one, imply that this is a sign. The fact that FDA is saying, hey, here's a draft guidance that's describing what one needs to do to transition away from EUA. It's pretty blatant, right? It's a pretty obvious sign.

Mike Drues: It is a pretty blatant sign, Jon, to use your phrase and I like that phrase. In my opinion, it's nothing new. As I said before, I said exactly the same thing two years ago at the whole beginning here, but this is the at least first official sign that FDA is moving in this direction. And I think in that sense, it's a good things. It's trying to be a little bit proactive in getting industry and getting companies in this industry to be aware that, Hey, EUAs are temporary. There is going to be an end. We don't know exactly when that is going to be yet, but we want to remind you that there is going to be an end. I personally, Jon, I don't need FDA to remind me of that. To me, that's a statement of the obvious and I've been saying this to customers two years ago. But for those people that don't have the benefit of having a good regulatory consultant on their team, I don't mean just a regulatory consultant, but a good one because a good regulatory consultant does not need guidance like this from the agency. This is just to me common sense. But at the end of the day, companies should be prepared. And if a company wants to be passive and wait for FDA to give them a specific date, okay, fine. I mean, that's their decision. But in my view, Jon, I would much prefer to be proactive. I would get that process going already if it's not already going so that you're not caught in between. I mean, to me, that just makes common sense.

Jon Speer: So if you're a company listening who has a EUA product and it doesn't have any other 510( K), De Novo or PMA without a COVID indication, basically what you should hear from our conversation is that you need to get going. You need to start that process. I think FDA even suggests that whether or not this makes sense or not, we can tell about that too, but even suggested possibly even engaging FDA on a pre- submission. But nonetheless, you need to start the ball rolling because if you're going to wait until that date is announced, there's a pretty good chance that you're not going to get through all the steps and the details and all the processes that you're going to need to go through in order to keep your product to market. So basically, you're probably going to add exit the market maybe before you wanted to. So you need to get ahead of this right now.

Mike Drues: I would agree a hundred percent with that advice, Jon. I think that's very prudent advice, but I would actually take it one step further.

Jon Speer: Sure.

Mike Drues: I would also not make the assumption, as one of my new customers did prior to starting to work with me, that the regulatory burden for the EUA is the same as what it would be for a 510( K) or De Novo and therefore, all we have to do is essentially resubmit the same information for the 510(K) or the De Novo as we did originally for the EUA. I would not make that assumption at all. On the contrary, if you have a device on the market that's only on the market as an EUA and not under some other regulatory identity, I would, for all intents and purposes, Jon, recommend forgetting what you did for the EUA and starting out with a blank piece of paper and ask yourself the question, okay, if you were bringing this product to the market for the very first time as a 510( K) or especially as a De Novo, forget about what you did for the EUA. What would you need in terms of benchtop testing, maybe animal testing, maybe even clinical testing to support that submission? And then once you do that regulatory burden assessment, then you can go back and say, okay, what data can we cannibalize? Can we repurpose from our original UA? And what data can we also cannibalize or repurpose from the period of the time where the device is on the market, under the EUA( i. e., post market surveillance or real world evidence) and then do a gap analysis to see okay, of all of the data that I have through today, what's the difference between that amount of data and what I will need for this new submission? And that's the kind of analysis, that's the kind of strategic thinking that a really good company will go through even before taking this to the FDA as a pre- sub. Because otherwise, you're going to run into the same situation that this other company ran into. Hey, what you did before is not enough for what you're wanting to do next. And that's the proverbial, the deer looking into the head. Wouldn't be surprised.

Jon Speer: I know we try to stay away from finite timelines, but to give folks listening a bit of perspective, with a timeline element to it, let's imagine that you submitted a pre- submission today. You make this assumption that I can essentially submit the same information for my 510( K) as what I did to get EUA for my product. But I'm going to verify, so to speak, that assumption by getting a pre- submission with FDA. Well, for all intents and purposes, that's at least a 60 day process. And some branches aren't even accepting pre- subs. Now I don't know if that's changed. But anyway, so that's at least two months and now FDA comes back and says, oh, we don't agree. You should do X, Y, and Z or whatever the outcome is. So now you're at least two months behind. So do the math folks. If you're not on it, if you're not building a plan, a strategy and starting to execute that strategy, you're going to be leaving the market with your products.

Mike Drues: I couldn't agree more.

Jon Speer: All right. Anything else you think is pertinent or important for folks to take home on this impending EUA termination that may be coming to us soon?

Mike Drues: Well, good question. Just to recap, so keep in mind that an EUA is one pathway to market for certain medical devices, but it's only one. And remember, you need to have an overall regulatory strategy. I had a customer come to me, which actually I decided not to work with because they wanted me to help them with their EUA strategy. And I said, okay, fine. I'm happy to do that. But what about your overall regulatory strategy? And they said, no, no, no, we don't need help with that, just with the EUA. I said, well, thank you very much, but I don't want to work in that kind of a situation because that's like asking a surgeon to do surgery with one arm tied behind their back. You need to understand, I don't mean you literally, Jon, but our audience needs to understand that the EUA needs to be part of your overall regulatory strategy. How does it fit into the big picture, whether you're going to have a 510( K) or a PMA or something before or after and so on and so on. So that's one thing to keep in mind. Another thing to keep in mind is, as we've talked about, these are all going to time out sooner or later. We can speculate the dates, but it doesn't matter. They're definitely going to go away and you need to have a transition plan of your own. FDA is starting to put together a transition plan, but don't wait for them to do it right. You need to be proactive and do it yourself. Don't assume that the amount of data or evidence that you gave them for the original EUA is going to be sufficient for your next submission, because I can just about guarantee it probably won't be. And finally, don't waste FDA's time. Go to FDA with a well thought out, well anticipated plan. As a consultant for the agency, Jon, and we've talked about this before, some of the stuff that I see come into the agency, especially in the area of EUAs and pre- EUAs, it is 100% crap. I hate to be so flagrant about it, but that's the most polite word that I can describe it. It is literally just a bunch of you know what. So make sure that you know what you're doing, you have a well thought out plan and if you don't or if you don't have expertise in all of the different areas, then seek out people who do, because none of us, myself included, can be experts in everything. But we have an obligation to go to the FDA and be professional and be able to not just explain to them what we're going to do, but why we're going to do it.

Jon Speer: Absolutely.

Mike Drues: That's advice, Jon, you've heard me give many times, not just to an EUA, but to regulatory across the board and just plain in the medical device business. I don't know. Maybe, Jon, I'm naive. Maybe I fell off the turnip truck yesterday. But that's my approach to this game and in the 30 years that I've been playing this game, I've been reasonably successful doing it.

Jon Speer: Yeah.

Mike Drues: So those are some of my final thoughts, Jon. Is there anything else that you would add to the list before we wrap this up?

Jon Speer: Well, I don't know if we beat the topic to death, but the time to take action is definitely upon us. It probably has been upon us for quite some time, for those who have EUA products. If you don't know what to do or how to do it or how to define a strategy that makes sense and all those sorts of things, I mean, do ask for help. It is okay to ask for help. It is, in my opinion, less acceptable to not ask for help and just plead ignorance because you're making devices that impact quality of life. I keep coming back to that. So ask for help. And Mike Drues with Vascular Sciences, one of, if not the best, regulatory resource you can have in your corner. He thinks about your challenge as a medical device company and your regulatory strategy, frankly, a lot differently in a good way, than anyone else I've ever interacted with in this industry and have been doing this myself for 20 plus years. Great person to have your corner, so reach out to him. I want to thank Mike. It's been a bit since you and I, at least our calendar time, have chatted, so it's good to catch up. And I think this is a great timely topic and I'm sure the next time we chat, we'll find another one. But thank you, Mike, for your insights on this.

Mike Drues: Thank you, Jon. Always a pleasure and happy holidays to you and to our audience and all the best in the new year and I look forward to continuing having these discussions together.

Jon Speer: Absolutely. And folks, if you are just a regular medical device company, or maybe you're a company that does have a EUA device on the market and you need some help figuring out what GMPs are or what quality systems are, how to document and manage design controls and risk management and all the things that you're going to need to have in place as a real legitimate compliant medical device company, well Greenlight Guru, we have products and solutions that can help you. We have the only medical device success platform on the market today that's designed for the medical device industry by actual medical device professionals. So we're working with hundreds and hundreds of companies across the globe, quite a few of which actually have EUA products and we're helping them make sure that they can continue to stay in market after this EUA period ends. So if that's something you want some help with, then reach out to us, www.greenlight.guru. We'd be happy to have a conversation with you and help explain our products and services and understand your needs and requirements and see if we have something that might work for you, so check it out. As always, thank you for listening to the Global Medical Device podcast, the number one podcast in the medical device industry and that's because of listeners like you. So thank you for continuing to do so and continuing to spread the word to your friends and colleagues. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device podcast.

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