EUA and the Impending Transition

October 26, 2022

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There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. 

Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. 

Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.

Listen now:

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Some of the highlights of today’s show include:

  • Whether there’s an EUA transition deadline yet

  • What EUA companies need to be doing right now on the quality side of things

  • What the EUA transition will look like

  • How adverse events need to be documented

  • The potential for the EUA as the norm in certain situations

  • What to focus on for companies that started with a non-med device then got into the EUA

  • What happens if you go past the 180 days


Rook Quality System

Kyle Rose

FDA Guidance Document

FDA Webinar Slides

Etienne Nichols LinkedIn

Etienne Nichols Email

MedTech Nation

GG Academy

Greenlight Guru

Memorable quotes from Kyle Rose:

“This is going to end, and companies have to figure out what to do to go back to their traditional regulatory path for their device or their expansion of labeling and use to maintain compliance.” 

“You need to start working on this before phase three.” 

From phase one to phase two is 90, from phase two to phase three is 90, and then phase three it says 180 days after implementation”

“If you’re going to build your quality system, I would definitely say you can apply with both FDA and ISO.”

“If you have submitted, and it goes past the 180 deadline into phase three, you’re still able to sell as long as you’re under review”


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.

Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols, and I'm the host of today's episode. In today's episode, we spoke with Kyle Rose on the topic of EUA and the transition away from Emergency Use Authorization. Kyle is the president of Rook QS and works as a contract quality manager for multiple medical device companies, overseeing overall quality strategy, ensuring compliance through documentation and auditing services. Kyle is also a certified quality auditor, CQA, and has regulatory and submission experience for a variety of markets, including FDA, CE mark, Health Canada, and CFTA. We cover a lot of ground. We talk about things like what is the history and known timelines for EUA? What should companies be doing in preparation for the transition? What are the best practices when it comes to complying with the FDA guidance and much more. If you're a company that is preparing to transition away from EUA, I'd like to hear from you. Let us know. We love hearing from those in the trenches, and it'd be great to hear what your experience is currently. Without further ado, please enjoy this episode with Kyle Rose on the EUA and its impending transition. Hey, everyone, welcome back to the Global Medical Device Podcast. This is Etienne Nichols, your host. Today with me is Kyle Rose. Kyle, it's so good to have you back on the show. How you doing?

Kyle Rose: Thanks, man. Great to be back as well. Definitely excited to be back. It feels like it's been a while since I've been on the podcast, but yeah, definitely excited to chat with you and go over some of this EUA transition timeline stuff.

Etienne Nichols: The thing with the EUA, I just wanted to ask you real quick, I haven't seen an actual deadline yet. Do we have an EUA transition deadline yet?

Kyle Rose: They have a draft guidance that proposes timelines, but there is no deadline yet as to when this whole EUA process will end. I think it might be in phases as well. There might be certain products that get termination earlier than other products would be my leaning. From some of the stuff we've heard it, it's still probably sometime next year that they would do this. I don't think it's anything super, super urgent. But as we'll talk about, I think there's still stuff that companies can do to prepare now and probably should do as well just to make sure they're still compliant and we'll be ready when this goes into effect.

Etienne Nichols: And that's a great point. Maybe before we get into what you need to do to prepare for that, I mean, what kind of impact does it have on people once that EUA is over? Do you have thoughts on what the transition is going to look like so far?

Kyle Rose: And just highlighting a little bit about the EUA process for companies that might not be super familiar, during the COVID pandemic, the FDA proposes Emergency Use Authorization. It was for a wide or is for quite a few types of products. Most people think traditionally of your COVID diagnostics and your masks and things like that, but they also have guidances for other things like remote monitoring, tools that are allowed to provide oxygen and different things for people, SaMD devices for treating psychiatric disorders, sterilizers and effectors. There's a wide range of other devices that kind of tie in closely with the COVID pandemic and the public health emergency that also have modifications to their traditional regulatory scope during COVID. The FDA allowed and put out guidances for all of these different types of devices and diagnostics to say, hey, you can either expand your scope or you can put this new device on the market without a traditional 510( k) registration just to allow easier access for these devices, allow people to use them in new settings, such as at home if it was currently used for just in a hospital setting. The FDA allowed more devices to expand their scope, expand their use, and in some cases, go to market without having previously submitted to the FDA. This whole process was really a great tool. FDA provided a ton of information, especially on the diagnostic side on exactly what they're looking for, which some people have seen with 510( k), sometimes it could be hard to know exactly you're searching for predicates and what tests that they do. EUA templates provided a really good outline in what was needed, but the whole transition is this is eventually going to come to an end, right? This is going to end and companies have to figure out what to do to go back to the traditional regulatory path for their device or their expansion of labeling or use to maintain compliance. That's the big thing is, what do we do next? How long is this going to last and what documentation do we need to collect and show to keep selling this device if these companies want to?

Etienne Nichols: I assume there's a lot of companies that maybe they weren't medical device companies before the pandemic, but they jumped in to help out with the masks, like you mentioned, maybe software companies helping with the psychiatric side, so forth. I would hope, of course, we've been in this pandemic for a little while. Likely they know what they need to be doing to be correct as far as... And not just saying,'Hey, I'm an emergency device. I'm just going to go do my thing." I mean, there's processes to become EUA. Maybe you could talk a little bit about that, but also on the quality side. We've got the regulatory side with the EUA submission type thing, but then also from the quality side, what were the requirements there? If I'm an EUA company, what do I need to be doing right now, and then we'll talk about to prepare. What are your thoughts?

Kyle Rose: That was kind of the scary part coming from me as a heavy proponent of quality systems and a quality system consultant was some of the original templates from the FDA specifically for the diagnostics had language in there that said you can skip certain requirements for the quality system regulations. You can skip some designing control on some things like that. Some companies really took that to heart and didn't do much at all, if any, on the DHF and the risk side. The majority of the companies that we worked with, and we've worked with over 50 COVID diagnostics, as well as all the other types of devices as well, we were pretty strong on the you still need to do some documentation. It might not be as stringent as you typically do, but we always said even from the start that you needed to have some DHF and risk in place. Because if you don't document it, how do you know what you're making? Stuff like that. But there definitely were companies that went straight to testing, got an EUA, and even some of the early EUA process that got through, and we've talked to them since then and there's big gaps. They don't have a DHF. They don't have a strong quality system in place. A lot of them, like you said, were coming from not manufacturing devices. We met some carpet manufacturers that started making face masks. We met academic labs that had never worked in any regulated industry and are now making medical devices. There's a lot of knowledge gap and I still think there's a lot of companies out there that got an EUA, are selling product, but still have lots of gaps both on the quality system side and that's going to translate into the regulatory side as well.

Etienne Nichols: I mean, I'll just ask, do you have any numbers as far as who you think maybe their EUA now and they plan to continue after the EUA transition closes out? Or is there a certain number who are going to say, " You know what? We're done with medical device?" Any thoughts?

Kyle Rose: Yeah, I don't know for sure as far as percentage how many are going to continue. I think there are a lot of devices in the market. But as we're seeing even now, the more people I talk to, I'm seeing a lot more people that are having spouts with COVID again, right? It's everyday I meet somebody else that has it. Definitely not going away. I think the need for tests and mask and all that stuff is still going to be there. I would assume most of these companies are going to continue. I would guess if they were the ones that did very little on the quality and regulatory side and then see how much it is to catch up, they might be the ones that are determining whether or not it's worth the investment to keep up with the device and go through this whole regulatory 510( k) process as well. But hard to say how many are going to keep it. I think it did start a lot of companies that saw the opportunity and created a company just from this need for these medical products and this public health emergency. I definitely think there's hopefully lots of companies that were established and help maintain and either pivot into other types of diagnostics or markets or still continue to support COVID related products as well.

Etienne Nichols: Yeah, that's a good point. Probably is going to boil down to a lot of financial side, I'm sure.

Kyle Rose: Yeah, just like everything, right?

Etienne Nichols: Interesting side note, you mentioned a lot of people still are getting spouts with COVID. I currently have COVID. Forgive me if I'm not at a 100%, but they tell me, hey, you should at least be able to be 80. That's where I'm at, so anyway. It's okay. I'll make it.

Kyle Rose: You didn't take a day off at some point.

Etienne Nichols: Not when you work from home. Not allowed. Let's get into the transition. These companies that got their EUA in place, what does that transition look like?

Kyle Rose: That's a good point. A lot of them do have an EUA. There are some that FDA also said, " We're not regulating this. You're able to sell it within this scope, but you don't necessarily have an EUA." There are some that formally submitted EUA. Just to clarify, there are some products like a lot of the psychiatric ones that didn't necessarily have to submit, but they are within that medical scope of providing medical. It's kind of a hybrid of both. A lot of them did have stuff reviewed, some just went straight to market without any EUA or any other reviews. There is kind of a transition for a lot of these that will need rethinking on the regulatory side and additional quality regulatory. But as far as your original question, yeah, FDA put out this guidance in December of 2020 outlining the three phases of this transition period. When they give this date that says the PHE and the EUA process is going to end, everybody needs to comply, their timeline is 180 days from this date. There's a phase one, phase two, phase three that kind of breaks down what you need to do at each section. Within this transition, they've outlined what you need to start to comply with, what records you need to start to populate.

And then if you are one of the devices that fall into the we need to file a new regulatory submission or we need to amend our current for this updated labeling or expansion of use, then you need to do that as well. But high level timelines, there's the initial date and then there's 180 days to the phase three, so six months roughly to do this. Phase one is pretty easy. The only thing that they're really wanting companies to do is to start to comply with the adverse event reporting requirements. Make sure you have your procedures in place for your MDRs, and make sure that if there are any adverse events that happen during this use and you didn't submit them for some reason, that you do submit them to the FDA, which was something I was a little surprised by. The reporting has always been part of the IVD specific EUA, so I was a little surprised to see that some of these allowed for adverse events that weren't reported. But that is part of the phase one is to make sure you have procedures and training for adverse event reporting, and then make sure you submit anything that happened while this device was used under EUA.

Etienne Nichols: Which to your point, that suggests that you should be tracking that currently.

Kyle Rose: Exactly, yeah. If you're not currently tracking that, that is something... Like I said, we've seen companies that have never sold in the US. They didn't necessarily have the procedures in place. Same thing. They had a diagnostic in another country that they were selling and it was very good with protecting COVID and they put it on the market for FDA EUA, but they didn't necessarily have procedures for the FDA MDR reporting. That's a big gap for those companies as well, is making sure that they add that. Because if you're following CE, if you're following ISO, the reporting requirements, as you know, are different for the FDA, right? You have to have that in place and then file those reports as needed.

Etienne Nichols: Those adverse events, do they need to be basically documenting all customer feedback? I don't know. What thoughts can you give there?

Kyle Rose: As you know, the process of getting all feedback and then evaluation. First, is it an adverse event? Was somebody seriously injured or killed? And then second, if that doesn't apply, is it a complaint alleging deficiencies to all the scope of what that is for the FDA? If not, then it's just your normal feedback. But in order to actually be able to identify adverse events, you have to have a process in place and documentation and training of the people involved to be able to identify what is an adverse event, what's a complaint, what's just general feedback stuff.

Etienne Nichols: Okay, yeah, makes sense. Okay, so that's phase one. What about phase two, or did we miss anything with phase one?

Kyle Rose: No, no, that's phase one. Phase two would be 90 days after. This has three kind of parts. The first one is FDA registration. This is if you're planning to continue to sell the device, you need to go ahead and register with the FDA. For companies that have never done this before, pretty straightforward process. Go onto the FDA's website. You pay your fee in the 5,000, 6, 000 per year range and you submit the information on your company. Two or three days later, you're on the FDA's website. And a few weeks, later they send you your registration number. Pretty straightforward process, but it opens you up to you're formally on the FDA's radar. You can get audited, all of that type of stuff. If you haven't done your registration, you'll need to go ahead and do that as part of that phase two, which is 90 days after phase one. You'll also need to comply with the removals and corrections part of 21 CFR, so that's part 806. Make sure you have that. And then if you are a life supporting or sustaining device, there are some requirements notification of that as well. If you are a life supporting, life sustaining device, the FDA wants to have a notification of intent that you continue to move forward with this as well. A little bit more formal process for these higher risk devices that you're going to work with the FDA, they want to know kind of what guidance you were using, what number or submission number if you had an EUA or a previous 510( k) model numbers, manufacturing information around the manufacturer and if you're going to submit and if there's any amendments to your current 510( k). This would apply on some of the ones that might have changed indications, might have expanded the scope of use type thing, then they'll need to work proactively with the FDA with this notification of intent in phase two.

Etienne Nichols: Okay, cool. We got phase one, and then phase two 90 days out. Some of those things that you mentioned as far as registering your company, but then also the device itself. It makes sense. What about phase three? What have we got in that one?

Kyle Rose: Phase three is kind of the coming to the end. This will be the 180 days after the implementation date. This is really where you have to either be in compliance, or you have to remove your device. This is the end of the six month period. This is when you would have to have your full quality system compliance. You need to have compliance to the rest of the 21 CFR. Everything needs to be in place for your device. UDI compliance needs to be done as well. That was a big one that a lot of companies that was waived during the EUA for everything, waived for diagnostic, waived for everything. For anybody that's gone through UDI in the past, they know it's a pretty big process. Just all labeling, all the filing, all that barcode creation stuff, it's pretty big. The UDI, as well as the full quality system I think are the two biggest things. The other one is on the submission side. If you haven't already identified whether or not your device needs a regulatory submission, you need to do that and you need to submit this before phase three. It's kind of phase three is the end of it, but you really should start working on this regulatory submission, whether it's a 510(k), a NOBO submission, a PMA, whatever it might be. You need to start working on this before phase three. If you haven't submitted your new submission, we'll say 510( k) for example, before phase three, they're going to assume you're not going to continue to distribute your device. Phase three feels like it has some extra time. There's an extra 90 days. But really if you haven't submitted, you're already way behind. When this date comes, you should be looking at phase one, we need to really start as soon as we can with a submission, because six months is not a lot of time when it comes to putting together an FDA submission, especially if there's gaps from your design and testing and risk analysis and documentation of software, hardware, all that stuff. Six months is moving very quick to put a 510( k) together. Phase three is really that kind of we're getting close to the end. If you want to keep, you should have already done a good amount of stuff and they should already be talking with the FDA. You should be under the review by that phase three timeline.

Etienne Nichols: That's the part that I kind of wanted to ask you a little bit about from your experience. Let's just assume we've got a company that has... We'll just go with something simple like... Well, yeah, we'll go with the Class I device, I guess. I don't know what all EUAs. I don't know enough about are they typically Class II? Do you know of the breakdown there?

Kyle Rose: It is some Class II. Some of the software ones fall on the Class I as well. There's a little mix of both.

Etienne Nichols: Well, let's just assume we have a device that they don't have a quality management system. They're looking at these dates. Is it 30 days with phase one?

Kyle Rose: Phase one, I think it's 90 days. It's kind of 90, 90, and then phase three.

Etienne Nichols: Is that right? Actually, let's just double check that. I'm sure you got the numbers up there. Phase one, phase two would be 90.

Kyle Rose: From phase one to phase two is 90, from phase two to phase three is 90, and then phase three, it says 180 days after implementation.

Etienne Nichols: Okay.

Kyle Rose: Phase three is really the... They're going to start removing stuff from the market if you haven't submitted. Phase three is really the end of the 180 days, but it's still an ongoing process. If you've already submitted, you can still sell, but you should have already had it in the works and talked to the FDA, gotten something on their radar. You submitted. You're in the process before phase three.

Etienne Nichols: Okay, thank you for that clarification. I think I missed that fact. Let's say we've got a company that doesn't have a quality management system and they're thinking, " Okay, well, once this is implemented or this transition timeline is basically mandated by the FDA, that's when I'll start working on this." Is that really realistic? I know we said it kind of takes a while, but in your experience, what would a Class II device with who they need to submit an 510(k) for the regulatory side, but they also need to implement a quality management system, what do those two things generally look like without being too specific? What are your thoughts?

Kyle Rose: I mean, we typically tell companies six to nine months and that's when the product is pretty close to being finished. At least with these devices, I would assume that they're finished, right? There's no major design changes going on. They've already been selling this through EUA. The product should be at a state that we can go back, look at the DHF, do a gap assessment or an audit of the current design and risk and testing, and then start to build that up to get into an actual 510( k) submission. Hopefully there's data they can leverage from some post- market stuff. Hopefully they did some testing that could potentially go into the 510( k). But as you know, I'm sure looking through companies you've worked with, a lot of times there's a big gap between what companies think the testing is required versus what the FDA actually wants to see and what falls within the actual regulations of device testing. I think six to nine months is what we typically say. I think that's the same approach. You you'd want to start planning a little bit in advance to get this in there.

Etienne Nichols: I definitely would underscore what you said about UDI. If there's someone who's listening to EUA who maybe they're not familiar with a UDI, which could potentially be the case, but unique device identification, that's the specific number that goes on your device and goes into the good ID. All these acronyms that FDA has.

Kyle Rose: Medical device.

Etienne Nichols: Anyway, there's lots of different little nuances. I don't know. Any others that you've seen that you anticipate potentially being a pitfall for some of these companies?

Kyle Rose: I think that the UDI is definitely a big one. I think specifically with our work on some of the CBT or the SaMD psychiatric devices, the FDA wanted kind of a high level, what testing did you do? Did you have traceability? Did you have cybersecurity? But with a traditional software submission for a 510(k), there's a lot more documentation on the risk analysis, all the requirement definition, and then also mashing it to a predicate. That can be a part of it that's really hard too. If you have a device that's indicated for some type of disease or disorder and there wasn't a clear predicate, you might have to go into a De Novo path. Even though you were already selling it under this EUA process, if there's not a clear predicate, it could be pretty hard for you to make the case that you're substantially equivalent to another product. That kind of gap in a lot of those behavioral therapy and psychiatric disorder software devices or digital therapeutics on the actual predicates is something that we've seen working with some of these that might be hard. You might think, " Oh, it's clear we've already done all the testing," but the predicate part can be hard as well as finding a predicate. And then on the diagnostic side, the FDA had a pretty good plan of how many people you needed to test, how many symptomatic not and asymptomatic you needed to test for this actual diagnostic. In the EUA, it's a lot more for the 510( k)s. There's already some 510(k)s that have been cleared for COVID diagnostics, but it's a lot more data that you need to show for that. I think that's a big gap. The EUA templates are great, but you're going to need a lot more data to actually submit your 510( k).

Etienne Nichols: That's a really good point which you mentioned as far as the De Novo process and the potential that you might not. I guess in my mind I could see that could be something a company could be doing right now. Hey, is there a predicate? That seems like a pretty no brainer.

Kyle Rose: Yeah, for sure. It definitely is going to change your timelines. If you're doing De Novo, you might need some pre- submission. You might need additional just regulatory planning and conversations with the FDA. That might go from six to nine months to well over a year quickly. If that's the case and you have been selling and you're currently targeting a medical software therapy type device, you definitely want to look at that early on in the process as well.

Etienne Nichols: I want to ask something else about the adverse events we talked about with phase one and how they need to start reporting those things, as well as submitting anything that had been reported. Question about that, almost feels like a little bit of, I don't know, a loophole. If I'm a company and maybe I haven't been supporting it, it might be tempting to say, " Well, we haven't gotten any." In the event that that happens, obviously aside from the ethical side of lying, I mean, I would hope none of the listeners would be in that situation. But what is the case if you haven't been paying attention to that or if you haven't been recording those, of just not submitting anything, any thoughts on how the FDA could respond?

Kyle Rose: I mean, if you haven't submitted them and you have essentially a backlog of these, then I think you definitely need to have the additional quality paperwork in place that kind of follows along. The adverse event report is part of it, but also you would need to have some carry on corrective actions or design changes or things that say, " Hey, we identified this issue, and then we went through the proper quality system steps to address it and fix it. And now it's no longer an issue." I think trying to say, " Hey, here's a bunch of adverse events that happened and we don't have any solution," is not the best strategy. Definitely doing the full quality system scope of addressing whatever the issue was, investigating was it related to your product or not or your device, and then moving forward with any design changes, labeling changes, software, all that type of stuff that goes with it. But again, this ties back to heavy quality system stuff that needs to be probably documented as well.

Etienne Nichols: It's interesting because I can appreciate what the FDA's trying to do and I actually really am impressed that they pulled this off and they have these devices. I mean, that's really great program.

Kyle Rose: Yeah, it was awesome.

Etienne Nichols: But now they're trying to implement it in phases, but it's a mess. It's kind of, I don't know, like a ball yarn. Can you submit adverse events and say we don't have a Kappa system because we don't have a quality management system?

Kyle Rose: I mean, that's always been our argument. Obviously quality system consultant, I'm a big proponent of quality systems and documenting it, not just because the regulations say, because it improves your company and improves your product. That's been our approach the whole time is you need to have this high level stuff in place for that reason. If you make a bunch of devices and you got through the bench testing, but you put them out in the market and they're not working and you're getting adverse events and complaints, then, A, nobody's going to buy it, but also you have all this regulatory headache that you have to submit and document and do all that as well.

Etienne Nichols: One of the last questions I guess, and we'll ask if we miss anything, maybe we could circle back, there's a transition away from the EUA to terminate it, turn off this program, which obviously a few years out from the pandemic, that totally makes sense. Do you see anything like a potential for this to be something of a norm in certain situations? I know there are different programs as far as... I don't know. What are your thoughts there?

Kyle Rose: I think it definitely was a good program and continues to be. I think a lot of the effort that the FDA did just to provide all this information and guidance around the templates and providing updates and town halls and guidances was amazing and a huge effort. I think it definitely should hopefully leak into other areas that they're providing more of this guidance and more clear identification of what they want companies to do to get to market. I know some of the safety and performance pathways that have been opened up for other devices, but FDA says, " Hey, you don't necessarily have to have a predicate. You can do this testing and submit and you're on." I think that might open up some of the pathways for this as well. They did a really good job with the COVID diagnostics on what exactly they wanted to see and how they wanted it formatted. Hopefully that can go into other things as well in the future. I think that would be great. As far as upcoming stuff, who knows when the next pandemic is coming. Hopefully not any time soon. I think we're all tired of pandemics. At least they have a framework in place on how to address it efficiently and still get products to market that I think are really useful.

Etienne Nichols: Something else that occurred to me, it seems like maybe an off topic situation like a periphery topic, but QMSR. When we have the FDA is planning to align part 820 with ISO 1345, likely when we have this transition, that is probably going to be similar timelines I would assume. That might be worth mentioning. Do you want to touch on that?

Kyle Rose: Yeah, and I think that this kind of path of how they're breaking out the phases and how companies will need to address gaps and move towards compliance I think could follow a similar pathway as well. The QMSR stuff I think will probably be more 2023 where they really publish what they're going to do and what it's going to look like, and then probably a year or two years for actual implementation. We're looking'24, '25, but there will be overlaps. Some of the stuff I've said on the topic in the past is that they already have a really good framework with MDSAP companion audit documents that outlines and already aligns 21 CFR and M 1345. I think the QMSR information is already out there if you want to go look at it that way, but the transition plan I think would follow something like they're doing with the ending of the EUA process. They'll be a guidance document on what you need to do, how it's going to be audited, when it's going to be enforced, all that type of stuff.

Etienne Nichols: I don't want to just load a lot of information that might necessarily be relevant on companies who are, hey, I'm just focused on what do I need to do to be EUA. I'll just ask what your advice is. If I'm a company that is planning to do that QMS, et cetera, planning ahead, would it be best practice to just go ahead and focus, you know what, maybe ISO 1345 is what I should be focusing a little bit more on? I don't know.

Kyle Rose: I think definitely if you're a company that is just selling under EUA, say you're one of the ones that started from non- med device, got into EUA kind of bare bones with your quality system, I think this transition draft document should definitely motivate you to get serious on your quality system and get a plan in place for your regulatory if you continue to sell it. And if you're going to build your quality system, I would definitely say you comply with both FDA and ISO. We've had that approach for all of our quality systems since 2016 when the new ISO standard was published, and we build all of ours to FDA and ISO just because we think it's a more robust and comprehensive QMS. I definitely think if you're going and you're wanting to build it, don't just stick to 21 CFR because it's only going to last a year or two. Go ahead and build it to both. There's plenty of information out there. Obviously Rook helps with that Greenlights design for both as well. I think if you're going to do it and it's your first one, make sure you're complying with both for sure.

Etienne Nichols: Well, this is a great conversation. Did we miss anything? What are some other piece of advice? Anything else?

Kyle Rose: One thing. If you have submitted and it goes past the 180 deadline into phase three, you're still able to sell as long as you're under review. If you submitted your 510( k) and that phase three 180 days deadline has past, they'll still allow you to sell. You'll just have to have some sort of transition plan that you document with the FDA on what to do. If you get NSE or nonsubstantial or they have a ton of additional information requests that might force you to potentially hold your device and not distribute in that timeframe, that's still I think going to be more of a case by case basis. And then opposite too, if you ignore this or continue to distribute, you will get recalled and the FDA will show up, right? It's going to happen. They've already audited some of these EUA devices. They've already recalled a ton of COVID diagnostics. We had a company we had worked with and they had to go physically view them destroying all this product in person. It's serious. If you're not complying and you're trying to sell and you haven't submitted by this phase three, there's going to be a crackdown on a lot of these types of products. Make sure you have a plan. Make sure you're planning early. Now is probably the time. If you're already selling under EUA and you don't have a qms, then there's definitely gaps in the quality and regulatory side for sure.

Etienne Nichols: Quick question, you mentioned a couple scenarios there. If someone gets an NSE, a not substantially equivalent, you may have to hold the product. You also mentioned if you ignore it. But what about kind of the middle section where, well, maybe I should just ask that. What are some other options? What if you're rejected?

Kyle Rose: Similar, if you're rejected, then you would have to kind of pause selling. There are situations where you might have to notify clients in some sort of removal corrections, recall fashion. It really just depends on the product. The life sustaining supporting ones are more strict on that. I would assume some of the Class I is less strict diagnostics kind of in between. I think it just depends on each case by case. But yeah, it's definitely something. If it was me, I'd want to make sure my 510( k) is already submitted and hopefully cleared before even phase one starts, because then you know you're good, right? There's path out there, especially for the diagnostics, to go ahead and start working on this now. I would start working on that. If you are the case of the you might not have a predicate, even though you have a product currently on, then I would start looking at that as well and get some of that conversation going.

Etienne Nichols: Okay, that makes sense. Good advice. Cool. Well, anything else? I mean, I covered a lot there.

Kyle Rose: Yeah, no, I think we covered everything I had.

Etienne Nichols: I think this is good. Yeah, for sure. Well, we'll put some different links in the show notes. Obviously the EUA, some of the draft guidance there. We'll put how you can get ahold of Kyle. Maybe I should just ask that. Kyle, where can people find you, see what you're up to?

Kyle Rose: Rookqs. com is our website. Kyle. Rose @ rookqs, email me. Also, you can contact through our website. We do a lot of stuff with Greenlight webinars, podcasts, so a lot of that stuff on there as well. We have a lot of content on our site as well with this information. I think we have blog post about this as well. Definitely you can look up some of this information on our site if you have additional questions.

Etienne Nichols: I listen to a lot of podcasts and at the end, some people ask you how can they get a hold of you. If you're listening and you just went through, actually shoot them an email. I'm curious how many people we could get to bother Kyle. But anyway, thank you so much for being on the show, Kyle. I enjoyed the conversation.

Kyle Rose: Yeah, thanks again for doing this while you have COVID.

Etienne Nichols: I wasn't trying to get sympathy, but I'll take it, I guess. Good conversation. Appreciate it, Kyle. Good to see you again. All right, take care, everybody. Hey, everyone. Thank you so much for listening. Just a few of the points I took away from this conversation are: first of all, we don't know when the FDA will start rolling out the transition from EUA, first of all. But per the current draft guidance, companies will have 180 days to comply. Secondly, the draft guidance gives a three phased approach to the EUA transition. Phase one, in the first 90 days, manufacturers must start submitting any stored adverse events and should also start preparing marketing submissions if they plan to continue distribution after the transition. Phase two, after the first 90 days and before the 180 days. For devices that fall within applicable enforcement policies, they have to follow 21 CFR part 806, which is reports of corrections and removals and part 807 subparts B through D, which is registration and listing. And then the second part of phase two is notification of intent for certain life supporting and life sustaining devices that should be submitted. Definitely check the show notes. We'll have more detail and link to the draft guidance as well. But phase three is after 180 days, FDA expects manufacturers to comply with statutory and regulatory requirements that are applicable to their devices. The expectation is that marketing submission should have already been submitted and accepted by the fda, including the manufacturer's transition plan. Another point that I got from Kyle is the best in class companies, they're not waiting to be told exactly what to do. They're already working towards compliance with the goal of true quality. If you enjoyed this episode, reach out to Kyle on LinkedIn and let him know. I kind of gave the challenge, shoot him an email, let's blow up his email box. But also I'd personally love to hear from you via email, Etienne. Nichols @ greenlight. guru, or look me up on LinkedIn. You can learn all about what we do if you head over to www. greenlight. guru. We're the only MedTech lifecycle excellence platform. And on top of that, we built both a community and an academy where you can go to join the conversation or learn more about the things we discussed on the podcast. You can find both of those at community. greenlight. guru or academy. greenlight. guru. Next week, we'll be speaking with Carrie Hobb on the subject of customer discovery for medical device companies. Very interesting topic, one I'm looking forward to. Definitely stay tuned. Finally, if you enjoyed this show, please consider leaving us a review on iTunes. It helps other people find us. It also lets us know how we're doing. Thanks, again. You're the best.

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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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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