GMDP-header-David-Pudwill

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? 

In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.”

Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.

 

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Some highlights of this episode include:

  • New FDA policies may drive discussions and gain different perspectives on EUAs by finding ways to navigate bandwidth and prioritize timelines.  
  • Current Crisis: For the FDA to handle and keep up with EUA requests, it’s open to suggestions and responsive regarding technologies and products.
  • Regulatory ramifications, side effects, and far-reaching implications of digital strategies and policies do not involve a simple rollback of software.
  • New Normal/Status Quo: FDA engaging in data collection and digital health to make decisions. FDA doesn’t intend to object, but use enforcement discretion.
  • Pros/Cons of Caveats: How can devices/studies be monitored remotely to maintain safety and achieve efficacy endpoints by following protocols? 
  • 21 CFR Part 820 vs. ISO 13485: During the pandemic, should the FDA waive compliance requirements to address potential issues, such as device shortages?
  • Global Regulatory Harmonization: U.S. FDA’s alignment and operations with Health Canada is expected to continue. Congress may need to get involved at some point, as well.

 

Links:

David Pudwill (Mr. Regulatory) on LinkedIn

Mr. Regulatory Website

Mr. Regulatory on YouTube

Acknowledge Regulatory Strategies

Emergency Use Authorization (EUA)

FDA - Overview of Device Regulations

Guidance Document - De Novo Classification Process 

Premarket Notification 510(k)

AdvaMed

Code of Federal Regulations (CFR) Title 21 Part 820

ISO 13485:2016 Medical Devices

Medical Device Single Audit Program (MDSAP)

Health Canada

European Union Medical Device Regulation (EU MDR)

Public Health Emergency Declaration

2021 State of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from this episode:

“[FDA is] definitely open to finding ways to navigate the path forward.” David Pudwill

“Once the cat’s out of the bag, it’s really hard to reverse this.” David Pudwill

“How do we appropriately monitor studies remotely and make sure that we’re maintaining safety and achieving efficacy endpoints because we are following the protocol robustly?” David Pudwill

“They retain the ability to enforce the regulation if they change their mind...but they have no intention of doing so.” David Pudwill


Transcript:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: Okay, folks. This is a really good episode. I know you probably heard me say this before, but this is a really good episode of the Global Medical Device Podcast. Joining me is Mr. Regulatory. I'll leave the suspense until you dive in, but Mr. Regulatory share maybe some predictions, so to speak, on some potential policy changes or updates that we might see from FDA as a result of some of the things that have been happening as part of the EUA and the current pandemic. So, 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. I'm pretty excited about this one. I mean, I'll give it away here in a moment. I guess serendipitously I came across the gentlemen that's joining us today. I was participating in Acknowledge Regulatory Strategies, recent Reg AF virtual event, and one of the speakers called himself Mr. Regulatory, and I'm like," I have to talk to this guy." So joining me today is David Pudwill. He is Mr. Regulatory. So David, welcome.

David Pudwill: Hey, glad to be here.

Jon Speer: We'll dive into some of the details, give everybody a little bit more of a background on who you are. So, share our folks a little bit more about your background and how you came to be Mr. Regulatory.

David Pudwill: Yeah. Yeah. So in the pandemic, I guess let's start more recently, we're seeing FDA come out with all of these guidances and information, and just trying to keep up on things for my own purposes and stay current with regulatory guidances. I was trying to wrap my brain around how I would go about that and how I might try to help other people stay current with just the fire hose of information that FDA was putting out. So I started reviewing some guidance documents for myself. I'd done a brief video and hadn't branded anything at that point and put that out on LinkedIn, and then started working with a couple other folks to help put together a video series. We came up with the name Mr. Regulatory, and the idea is to make it more broad than just me in terms of who we're engaging with and getting input foot. But at the moment, I am Mr. Regulatory and I am hoping that we can get some other folks engaged on that front. I'll lead out with just a brief disclaimer, and then give you a little bit more of my background. They're just to clarify that any statements or opinions are my own, and they're not of my current or any previous employer, including FDA. My background is for the last couple of years, I've been at ConvaTec, which is a global medical device company. Prior to that, I was at FDA for almost a decade in a couple of different roles, as a reviewer, as an acting branch chief. And I spent a little bit of time in the office of legislation as well during the 21st Century Cures work that was going on. Prior to that, I worked in the field with a company called St. Jude Medical, so I had some exposure to both engagement with patients in the clinic and in a hospital setting, as well as with physicians. And so my career run the gamut in terms of what I've seen from the commercial side of things to FDA side of things, and now in more of a business regulatory environment.

Jon Speer: Sure, absolutely. Folks, I would even encourage you to go to MrRegulatory.com. It's MrRegulatory, all one word, no spaces, no hyphens,. com. David also has a pretty good YouTube channel. There's lots of great videos. I just was taking a peak at this a moment ago. I realized I'm behind. I haven't caught up with all the latest and greatest episodes. You're pretty busy doing all these videos.

David Pudwill: Not as many as I'd like, but yeah, we're at episode 21. I'm trying to keep up to get back into a cadence of about two a week, which we'd been doing for a while, and then we fell out of, and look to get back to that. So, trying to cover new and old guidance documents. And actually, for the one we just did, I have to give a shout out. There were a couple of people on LinkedIn who had specifically asked for the De Novo guidance.

Jon Speer: Yeah, that's a good one.

David Pudwill: I'll be giving them a shout out on a reference when I announced that one on LinkedIn, but it's already on YouTube. So we are actually taking input from people who give us comments and trying to actually push those guidance reviews that people are thinking are going to be most meaningful for them.

Jon Speer: Folks, I would definitely recommend you go check out the Mr. Regulatory YouTube channel. Just search for Mr. Regulatory, David Pudwill, P- U- D- W- I- L- L. It should come up in the YouTube search. There's a lot of really great content. Getting into the weeds sometimes, but at the same time, if this is a guidance or regulation that's applicable to you, I mean, hearing David's insights are really invaluable. So I definitely would encourage you to do that and pay attention because he's picking up steam, so to speak, on episodes. But David, I want to get to today's topic. You talked about how Mr. Regulatory came to be, and that's sort of related, at least tangentially, to the topic we're going to talk about today. On the Global Medical Device Podcast on the past, we've covered a few different perspectives on EUA, the Emergency Use Authorization that FDA has had in place as a response to some of the COVID situations. But I thought we could take a little bit of a different twist on today and explore if there are some thing or some things that we can glean, or maybe this is a crystal ball of sorts of some things that we might see as new policies from FDA. What do you think?

David Pudwill: Yeah, absolutely. There are ongoing discussions as well, that the AdvaMed is having trying to drive some of this conversation, and definitely FDA. When I've heard from senior leaders in a couple of different contexts, they're definitely open to finding ways to navigate the path forward because as they've been handling all these EUAs, their bandwidth is really, really been up and strained and they're having trouble keeping up, or they will soon, even if they've kept up to date. They've done that valiantly, let's say. I think we're going to start seeing some of these timelines slip. And so, FDA is really looking to try to figure out how they keep up with everything. And they're open to suggestions. So I know a couple people have already provided some suggestions, but if anybody does have any input for FDA or recommendations, definitely send them in my direction and I'll put you in touch with people who you can pass those suggestions on FDA through.

Jon Speer: Yeah. Just my observation of the current state of affairs, specifically with respect to EUA, I think there's been some really, a lot of positives. There's been some side effects as well. I mean, the positives have been how responsive the agency seems to be with respect to technologies and products that are meaningful and needed in this pandemic time that we're living in. So that's been an awesome thing to see how responsive the agency has been. But what are some of the side effects that have happened from that?

David Pudwill: Yeah. So a couple side effects, let's say, that are more far reaching, I mean, there are definitely some side effects in terms of this situation, where FDA has put out a lot of guidance saying the various things that they do not object to in the current crisis. That has some far reaching implications for us when it comes to both the digital space where it's really hard. And we talked about this a couple months ago at the Acknowledge Regulatory Strategies, a couple of sessions about the fact that once the cat's out of the bag, it's really hard to reverse this. I was on a conference call where a Dr. Maisel, who's one of the senior leaders at FDA, had been discussing some of this specifically around digital. I mean, one of the pieces of feedback from those of us on the call on the industry side of things was really that you can't just roll back some of these updates. So if you allow something from a software standpoint during the COVID a crisis, it's not a simple roll back of software because you have all these different business compounding changes. And so you might be able to pull out a feature or you might be able to pull back some of these things, but it's not as simple as maybe I think it sounds. We do have people at FDA who understand that. But I think sometimes from the policy- making standpoint, there's maybe an expectation that," Well if you put a feature in, you can just pull a feature out," without thinking about all the ramifications there. So, I do expect a lot of digital software development is going to be more or less permanent to some extent and FDA will talk about the amount of time that they're expecting to allow some of these more lenient policies to remain in place. And hopefully, people are taking that time if they're impacted to collect the data that they're going to be able to use in future submission. So, I do expect to some extent, some of this is going to get sorted out in, let's say future 510(k) or other submissions to FDA, if you are regulated.

Jon Speer: Yeah, I think the timing of that, it's interesting too, because just, I guess it's now been a couple months, FDA announced the official formation of the Digital Health Center of Excellence. It seems like this would play pretty nicely with some of those initiatives as well.

David Pudwill: I'm sort of the opinion. They might not have done this intentionally, let's say, at FDA, but there's been a long time push to provide some more flexibility and Congress has been pushing for this for a couple of years. I would suggest that senior leadership even at FDA has been pushing for this. And there's been a little bit of reticence on the part at the branch chief or now division director level at FDA. To some extent, this has pushed in the directions that senior leadership and that the Congress has wanted FDA to move in. Hopefully, everything goes well because we're now setting the stage for again, that data collection and a new status quo for how FDA is going to engage. And if this goes badly, I mean, that's not great for the current situation or anybody impacted, but also just for the whole state of the landscape when it comes to digital health. We will see, I think, the situation either become a little bit more open and consistent with what we've seen the guidances go out and push now. This might be the new normal. Or if it goes badly and FDA sees negative ramifications from the decisions that they've made to deal with the pandemic, I think we'll potentially see a lot of clamping down. I'm hoping for the former, that things continue to open up. And this seems to be the direction the FDA is pushing.

Jon Speer: For sure. I've had quite a few conversations with folks from quite a few different perspectives and backgrounds. I recently had some conversations with some folks that are involved on the clinical research, clinical investigation side. I know at first, well, actually the first few months of the pandemic, it seemed like a lot of clinical investigation and clinical studies and things were pretty much came to a screeching halt unless you were developing something in the COVID space, but it seems like what I'm hearing anyway, that that activity is starting to pick up a little bit with some caveats. Can you maybe elaborate on some of the caveats and what are the pros and cons of those?

David Pudwill: Yeah. I mean, some of this is really an expansion in, let's say, remote monitoring of studies, and that's both in terms of, let's say, the remote monitoring, people oftentimes think about with, let's say, a digital device in your home or on your person, where maybe there's remote monitoring of cardiac signals or some other sort of relevant physiologic parameters. But then you've also got remote monitoring of study of the study itself. So where you might have a monitoring set up more locally in the past, and you might have different clinical specialists or people who are expert in helping nonclinical studies on site, you now have a lot of those folks working remotely and really trying to navigate how do we appropriately monitor studies remotely and make sure that we're maintaining safety and achieving efficacy end points because we're following the protocol robustly. There've been some guidances that have gone out on this for both areas, both in terms of device remote monitoring, as well as clinical study remote monitoring. Was there something else you wanted to get into maybe in terms of caveats and directions?

Jon Speer: That was really the gist. I mean, it's consistent with some of the feedback that I've heard, where a lot of these studies, once they've resumed, they've had to go to more of a remote monitoring. At first, it was trying to figure out the nuances, because this was a change. Now, granted it is 2020, and the technology extensively is there for folks to be able to do that, so maybe this is a positive change and hopefully one that we can work out the kinks, but one that I see it being extremely beneficial when we're not in a pandemic situation.

David Pudwill: Yeah. And I think initially, the expectation was that this was going to be, let's say, primarily for COVID kinds of studies or things that were mission critical, but it's gotten to the point where just any study you're looking to run, you can't just bring the entire world to a complete standstill for all the fact that we're more or less locked down in various parts of the world where we're having any virus spread. But the interesting thing is I think the implications now of remote clinic visits. I've seen a doctor by video now. I'm sure-

Jon Speer: Same. Yeah.

David Pudwill: ...a lot of other folks already have. It's interesting. We're starting to leverage the technology that we've had available for some time, and I think a lot of medical device companies as well, not just in terms of the clinical study inside of things, but even in terms of manufacturing and what personnel is on site for manufacturing and what we're doing in terms of other kinds of functions. I'm sure you've dealt with it from the quality management side of things and in terms of some of the clients that you guys support. It's a brave new world in terms of what we're doing remotely that I think many companies never would have considered doing remotely. Hopefully, it allows us to get to a point where we can actually get more robust data because we're actually fully using those tools and maybe more consistently collecting information remotely because that's all we have to go on. And so maybe we're even getting better information than when people were physically onsite and had a level of comfort maybe with what they were seeing that may or may not have been documented.

Jon Speer: Absolutely. Folks, I want to remind you all that I'm talking with David Pudwill. David is Mr. Regulatory. You can learn a lot more about him and his background by going into www.mrregulatory.com. Again, it's www.mrregulatory.com, all one word. You can also check out his series of videos on different guidances and regulations and whatnot by visiting his YouTube channel. Just go to YouTube, search for Mr. Regulatory David Pudwill, and you'll have at present time, 21 episodes to consume. It sounds like there's going to be quite a few more here in the near future, so check that out. I also want to take a moment to remind you a little bit about Greenlight Guru and why we're here. Our mission as a company is to improve the quality of life. We do so by providing a medical device- specific software platform to help you manage your quality management system. We have workflows that are designed for medical device professionals by actual medical device professionals to help you manage design and development risk, document management change control, post- market quality events, like CAPAs and complaints and so on. So if you're interested in learning more about how to build a robust quality management system via a cloud- based software platform, go to www.greenlight.guru to learn more. Request a demo, and we'd be thrilled to have a conversation with you to learn more about your needs and see if there might be some opportunity for us to help you out. David, predating COVID by... Gosh, I'm trying to think the first time that I heard this, but it's probably been a couple of years now. There was this discussion or maybe this comment that was thrown out there about FDA migrating away from CFR Part 820 in favor of 13485. It's interesting, because in current times, the current situation, do you feel like that that's pushing the FDA closer to that? I mean, I think the last time I saw something from the agency, it might have been earlier this year that express that there would be a timetable and that this is still an active initiative and that sort of thing. So, where do we stand on that particular topic?

David Pudwill: Yeah, I think that's another one where FDA to some extent is using the flexibility they have to continue driving these long- standing initiatives. So we've seen in a number of these guidance documents that have come out where FDA is actually waiving the requirements to be compliant with Part 820 for devices that comply with ISO 13485. Now, it's a narrow instances and primarily to address potential issues around shortages. Generally, they're recommending that this is not necessarily a last resort, but it's sort of lower down on the list of preferences for which devices you would use potentially. But FDA is pushing this, where they're starting to, at least in terms of the pandemic response, recognize 13485 in place of Part 820 for devices that are made overseas potentially and aren't already compliant with Part 820. So, we're seeing that movement. I think we're seeing that with MDSAP audits. I just had the pleasure of being part of the MDSAP-

Jon Speer: All right.

David Pudwill: ...audit. So, it is interesting to see just there as well. I mean, we already have clearly identified from that side of things where the differences lie, let's say between 13485, and then the regional requirements for those MDSAP countries, those five MDSAP countries at the moment. Fingers crossed, maybe we'll get the UK in there or something. So we're seeing movement here. I expect further harmonization. We see FDA pushing on the pre- market side as well still to try to further harmonize how they're operating. I mean, I just came across an interesting thing where it's the FDA online portal that you have to create an account on to actually register certain products in Canada, for instance. So we see closer alignment between Health Canada and U.S. FDA, and I fully expect that that engagement and that harmonization to continue. Definitely, Shuren's end goal is to try to get to a place where you don't have to figure out five different or 10 or 20 or 30 different ways of doing something.

Jon Speer: Yeah, absolutely. I remember when this topic first surfaced a while back that one of the rubs or the knee- jerk reactions that I heard was," Oh, the 820 is free. There's no charge for that, but you have to pay for ISO 13485." It's only a couple of hundred dollars folks anyway. Anyway, but I heard that how in the world can FDA dictate some sort of policy where it requires somebody to purchase something and that sort of thing. So certainly, Congress is going to have to get involved at some point. But it seems like the ISO community is paying attention too, because I think it was in August or something like that, I believe, and I'll find this link and I know I have it somewhere, but I believe there's a read- only version of 13485 that's free. So it seems like the ISO community is very interested in this harmonization as well.

David Pudwill: Yeah, I expect it to go one of two ways, right? So either the U. S. regulation gets updated to reflect 13485. So effectively, it's, let's say, free because at least the U. S. version of it, which is sort of harmonized is. Or potentially, you get to a place where... And probably the nearer term is where FDA gives you two options, because this is what they're doing, maybe on the pre- market side of things, let's say with 510(k) and some of where they'd like to get to it. And then I did this with a stead 510(k). I reviewed one of these when I was at FDA actually. It was a bit of a beast to go through. They didn't quite get it right yet because all this information's in there. And if you've got an FDA reviewer, even a trained FDA reviewer going through all of this, I expect you to get more questions. If you submit something in that kind of a format with information, they normally wouldn't see, even if they know better than to ask about it. But the thing that I expect to see is that we're going to get to a point where maybe you have two options. You can follow 13485, or if you so choose, you can follow Part 820. And probably, that's a middle term solution. And long- term probably Part 820 either completely harmonizes or or becomes obsolete and FDA abandoned that at some point in the distant future maybe, but we'll see. I mean, people don't generally object to, let's say, using the biocompatibility standard, ISO standards, but I don't know.

Jon Speer: I just think it's a good move. Personally, I'm a kind of a quality nerd, so bear that in mind. But whenever the 1345 2016 version came out, I mean, it was... And I've been doing this for a long time. I mean, any company that has an interest or potential interest in pursuing U. S. and EU and other global markets, chances are you're architecting your quality management system to meet the criteria of 21 CFR Part 820 and ISO 13485. Yes, it's entirely possible. It's a little bit more on the front end, but once you put it in place, it's not that big of a difference. And then when 2016 came out, I was like," All right, these are maybe three or four steps, even closer to being in sync with one another." So I think there's been a very concerted effort by all parties involved to move towards this harmonization goal, especially with respect to quality management system criteria and requirements.

David Pudwill: You can see that with FDA's, let's say, engagement in standards committees. I think there are a couple of outliers where FDA is maybe pushing the envelope in directions that the standard probably doesn't go in. And so you're still going to see a little bit of a disparity between what they fully recognize and what the standard ends up being. But FDA has been very, very active in standard development for a number of years. This has been part of the grand plan to some extent, is to get to a point where the standards do align with what FDA expects to see so they don't have to have a separate standard or something above and beyond that they expect you to do that's not in the standard itself.

Jon Speer: All right. So I want to ask a question about something that... It's come up from time to time over the years. It's always been a little bit of a head- scratcher. It seems to have come up more often in this EU, excuse me, EUA environment that we're in. And there's two phrases that sometimes you'll see or read from FDA. And the first is quote," FDA does not intend to object." And then the second is quote," Enforcement discretion." Holy cow, as a receiver of that information, I'm like," What does that mean?" What do you think?

David Pudwill: It's interesting because FDA has outlined effectively their willingness to allow devices on the market without pre- market clearance or approval for a lot of these do not intend to object sort of situations while retaining the expectation for notifying FDA that you're doing so, that you're putting the device on the market. Even though you don't need, let's say, their pre- clearance, they're expecting that you're going to do MDR reporting and outlining the potential need for a product recall. It's setting the stage potentially even for, I mean, maybe an alternate pathway to market products that may or may not fall within their statutory authority to some extent. It's like if FDA basically says," We're not going to..." It's the same thing with enforcement discretion to some extent. They basically say," We have the authority to regulate it. We have no intention of regulating it." But usually, that fallen in line with, let's say, direction from Congress, where Congress says," We don't really think that you should be doing this." FDA says," Well, we can. We have the the authority to do so." But this is where, let's say, with digital devices and mobile medical apps and all of this, FDA has used that enforcement discretion language a lot, where they basically set up regulatory framework. They've done that in other areas as well, but where they retain the ability to enforce the regulation if they change their mind effectively, but they have no intention of doing so. And they've made it fairly clear that they're not planning on enforcing the regulations in these areas. They clearly outline what that looks like. It gives a little of, let's say, stability within the industry. So you're not worried that FDA at any moment might change their mind because they've come out and they've clearly said," Look, we plan on using enforcement discretion here. But if somebody really egregiously crosses the line, we might do something about it." It's where that stands now. But with this, FDA does not intend to object. It's an entirely new paradigm to some extent. And FDA is allowing devices to be marketed more or less, or with new indications or without pre- review by FDA in areas where the regulations are pretty clear that they should go to FDA.

Jon Speer: Yeah. Now, there is something that I think listeners should be aware of, especially those who might have EUA devices on the market. I don't want to mislead folks. This is not implying that if you have EUA in the pandemic and EUA state is over, that you can continue. I mean, there's still an expectation that were applicable that companies need to follow on with 510(k) or De Novo or whatever the case maybe. Correct?

David Pudwill: Yeah. And FDA has laid out that there's going to be some kind of a grace period, let's call it, between the end of the public health emergency, which is how they've termed it. So between that date of whenever the public health emergency is determined to be over by the secretary of health and human services, between that point and when marketing applications would be required. And the expectation is, I mean, we're talking about probably in the range of six months to a year, in some cases maybe more, depending on what FDA comes to determine in an area by area specific situation. That's just between, let's say, when... That's not even necessarily covering removal of products from the market. That's the end of when you can continue selling products. So for anybody who's in this space, and as you would recognize, you might have product out there for a long time after that. Let's say, six to 12-month window, you sell your last product. A year after the public health emergency ends, hopefully you've now gone and collected some data, so you can get submission into FDA. And FDA might even grant additional ability to continue marketing as long as you have a submission under review. I can't say that's going to be the case, but this is the kind of thing that we've seen in the past, where FDA is going to give you a cutoff date for when you need a submission in, or you have to stop marketing. But if you get a submission into FDA, you might be able to continue marketing until you actually get your clearance or approval for that product.

Jon Speer: Yeah. Folks, I mean, it's definitely not entirely clear how that's going to unfold just yet, but do hear what David is suggesting that you have some responsibility here to take it to the next step, because at some point in time that next step will be applicable. And you've got this opportunity now. You've done an awesome service to the world by bringing your device to help in these circumstances that we're all living in. So continue the progress, gather that data, move forward with the appropriate and applicable submission.

David Pudwill: And the clear recommendation from FDA at the highest levels, I would say, and this probably goes down all the way to the lowest levels as well, as a former reviewer, I'd give you the same recommendation, don't wait to come in with a submission. If you've got the data that you think will get your product actually on the market, FDA is strongly encouraging you to come in as early as you can. And some of that is just to get yourself a priority status, because we are seeing some of these review time slip. Probably if you're one of these products that had an EUA, you get some level of prioritization, such as it may be in terms of FDA's review because you're one of these products that would potentially assist in the pandemic itself, but you want to get your place in the queue, if you can, as early as possible, even if it takes a little while for FDA to get around to giving you a clearance. The sooner you can get into FDA, if you've got the data you think is sufficient, go ahead and move forward with that. Don't delay until FDA tells you, you have to have your submission in by such and such a date. And then you find out that your submission is on eCopy hold. I don't know. I don't expect that to hold you up necessarily, but these are the kinds of things. The clock doesn't start until you're off your eCopy hold. You've paid your submission. We just ran into an issue where because of the way the fiscal year falls, if you request the PIN, let's say the payment, for the wrong calendar year, and then you submit just a couple of days later, well, now you haven't paid the right amount. So you've got to plan for some of these things as well, and figure out your timing so that you're not ideally submitting right after the beginning of October because it'll be a different fee structure. So, watch out for that kind of stuff as well.

Jon Speer: All right. David, we've covered a lot of grounds here today on this. Man, I've enjoyed this. Anything else that you think is important for listeners to glean from recent events and what we can learn on a go- forward basis that we haven't covered?

David Pudwill: Yeah. I guess the last caveat I would give listeners is that FDA has been doing an amazing job, I would say, in this pandemic and with all of the EUA burden. There have been some device areas in particular that are impacted both in terms of submissions, but also in terms pre- submissions. So my general recommendation to people is to get a pre- submission into FDA if you've got any questions, as you're trying to pull things together or figure out what testing do, if you've got the time to do so. But just be aware in the current situation, some of those pre- submissions are not actually being accepted by FDA. So just be aware of that as well, as you're thinking about submission timelines and what paths to take, that FDA is actually telling a number of submitters for pre- submissions that they don't have the bandwidth, or they've just rejected certain pre- submissions. And they tell companies just to submit your actual, let's say, 510(k) or IDE or other submissions rather than go through this pre- submission route, because they just don't have the bandwidth to deal with it.

Jon Speer: Yeah, makes sense.

David Pudwill: So be aware of that. Be aware of that. And otherwise, I would say even with that caveat, don't be shy about getting in front of FDA as soon as you can. Be aware that maybe they won't be able to accept your pre- submission. But even if you're early on in the process, very early on put together what it is that you'd like to engage with FDA on. As things open up a little bit more and as FDA's workload drops, hopefully a little bit here, or as they get more resources and staff to cover that gap, hopefully we'll see more engagements, so do. I mean, my strong recommendation, everybody, is engaged with FDA early. If you come across some issue, don't wait for it. I don't know. Keep on keeping on. We're all in this together.

Jon Speer: We are.

David Pudwill: I really do appreciate all of the good work that you guys in the Greenlight Guru team do. I can't speak highly and well enough-

Jon Speer: Thank you.

David Pudwill: ...for everything that you've done. So it's been a great experience as well on my part. It has been a great time chatting with you. Thank you.

Jon Speer: Oh, absolutely. David, thank you so much. Folks, again, help me, I guess, give a virtual round of applause to David Pudwill. David Pudwill is Mr. Regulatory. Go check him out, www.mrregulatory.com. Check out that YouTube video. If you haven't checked out either, you've got some catching to do, that there's awesome content from someone who's been on both sides of the fence, so to speak, and has a lot of insights and knowledge to impart upon the industry. So, David, thanks again so much.

David Pudwill: Thank you, Jon.

Jon Speer: Folks, as-

David Pudwill: Have a good day.

Jon Speer: Oh, absolutely. Folks, as always, thank you so much for being a listener of the Global Medical Device Podcast. It's because of you why this podcast is still the number one podcast in the medical device industry. So, share the word with your friends and colleagues. And to David's earlier point, if you have suggestions or topics that you'd like for us to dive into, send me a note and we'll be happy to do so. As always, thank you, and until next time. You have been listening to the Global Medical Device Podcast.


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

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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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