In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices.

Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes.

Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies.

Key Timestamps:

• [03:15] Introduction to PCCPs and Change Management
• [08:40] PCCP’s origin and application for AI-driven devices
• [14:20] Expansion of PCCPs to all medical devices
• [25:10] Practical challenges and best uses for PCCPs
• [34:55] Submitting PCCPs: Considerations and tips
• [45:30] Potential of PCCPs for non-software devices: 3D-printed knees case
• [52:40] FDA guidance and limitations for label changes
• [1:06:20] Final recommendations and quality system implications for PCCPs

Memorable Quotes:

• “PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn’t a blank check. It’s a pre-validation of boundaries.” — Mike Drues

Top Takeaways:

1. Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays.
2. Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster.
3. Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations.

References:

• Mike Drues on LinkedIn
• FDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissions

MedTech 101:

Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types.

Audience Engagement:

Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications?

Feedback:

We’d love your thoughts on the PCCP framework! Email us at podcast@greenlight.guru with your feedback, questions, or ideas for future topics.

Sponsors:

Special thanks to Greenlight Guru — the industry’s eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru.

Mike Drues: 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: Have you ever wished managing your medical device quality and compliance was simpler and maybe even more fun? With Greenlight Guru's EQMs, you get a single source of truth that connects your whole team. No more juggling spreadsheets or chasing down documents. Everything's in one place so you can focus on what matters, building life saving devices, streamline your workflow and make quality work more enjoyable with Greenlight Guru. Check it out at Greenlight Guru. Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episod. With me today to talk about PCCPs, which I'll tell you what that is in just a moment, is Mike Drews, a familiar voice on the podcast, President of Vascular Sciences. How are you doing today, Mike?

Mike Drues: I'm well, thank you for asking.

Etienne Nichols: Edien, good to have you with us today. So today we want to talk about PCCPs, predetermined change control plans. This is not necessarily something that's new, but it is something that may be new to a lot of people. How do you want to go about today's topic? How do you want to start?

Mike Drues: Yeah, great question, Eddie. And as always, thank you for the opportunity to have this discussion with you and your audience about this very, very important and potentially valuable topic to a lot of medical device companies. If you don't mind, Edien, let me flip things around a little bit. Instead of you asking me a question, let me start out by asking you one. So imagine this very, very common scenario. You have a medical device on the market right now, for example, under the 510k and you as the manufacturer, you want to make a change to that existing device, the device that's already on the market. The question for you, Edien, is what options do you have for making that change? How would you handle that?

Mike Drues: That's exactly correct, Edie. And this is a topic that we've talked about several times under the general umbrella of change management. So just to recap, a company has basically two options to change a 510 device when it's on the market. One is to notify the FDA, and that's typically done via a special 510. Or if it's a Class 3A PMA supplement. The other option is to not notify the FDA to handle it internally, as I think you said via a letter to file. And just as a reminder to you and our audience, Edien, that the most common reason why companies get 43 observations and sometimes even warning letters from FDA is because of change management or the lack thereof. And the reason why I mentioned that is because I've done several podcasts and I think one or two webinars for Greenlight on this particular topic of change management. So if that's a concern, we can put those resources up with this particular podcast. But what if I can tell you, Edien, that there may be a way to get a future change to your device approved by the FDA in advance? In other words, before you make it. Do you think that would be a good idea?

Etienne Nichols: The predetermined part is what I think would be interesting. I do think so. Change control in general, like you said, it's a risky topic, so one that a lot of people don't do well. So once you get that down, if you already know the changes that you plan to make, then absolutely I would want to get that in front of the FDA sooner than later.

Mike Drues: And this is the essence of this quote unquote new PCCP program. Basically it allows you as part of your original submission, whether it's a 510k de novo PMA, whatever, as part of your original submission to get a change to your device approved. And a PCCP is approved. So there is a little more confusion now with the terminology because for you submit a 510 which is cleared and within that 510 submission is a PCCP which is approved. I'm assuming, I'm sure that that's going to generate a whole bunch of confusion in the future, but Nonetheless you're getting FDA's approval, or blessing, if you will, to implement this particular change even before you've made the change. And that's the essence of the pccp. And this is what we're going to get into in more detail. As we continue our discussion. But another interesting sort of historical question to ask edien is where did this idea of the PCCP come from? Is it new, for example?

Etienne Nichols: I think we all like to think we're leaders in a certain way. A lot of people obviously aren't, but it does take courage to get out in front for sure.

Mike Drues: So maybe we should move on and talk about next. What exactly is a PCCP and why it's important.

Etienne Nichols: Yeah, let's talk about it. I mean, there's a couple different. It's a big acronym. FDA loves acronyms and important words in each part of it. So yeah, let's talk about it. Predetermined Change Control Plan.

Etienne Nichols: Oh yeah, totally. It was interesting when I first learned about this because I thought, well, because I remember in my days in manufacturing where we had a product that may have additional, additional features that we were planning on, but we hadn't got the cogs down for whatever reason, but we'd got them conceptually figured out. When I first saw this, I thought, wow, is this going to be a 2 for 1 combo deal on the Madupa? You know, you no longer have to pay half a million for an additional pma. That's an interesting idea.

Mike Drues: This. I've had customers ask me that question, is this a way that we can save ourselves some money on submission fees? And the short answer is, right now, potentially less. Assuming that Congress does not add a PCCP fee on top of the 510k or the PMA, that certainly could happen. Maybe I shouldn't have said that in a public podcast, but. But that certainly is the case right now.

Etienne Nichols: So far it feels like Congress is kind of on the side of manufacturing. I don't know yet. We'll see. But I think it'll be okay. I do have a question though. So kind of talked about what a PCCP is and why it can be beneficial. We mentioned those two guidance documents. Last year was the AIML specific guidance document and I think a lot of people didn't understand or recognize where this thing was coming from. And so they thought, whoa, this is just something special for the software industry or the AI industry. And now this year, I think it was August, we came out with this other guidance document that really is kind of harkening back to the, the original part that came through in the Omnibus Act. But what's the difference in these two? Do you have any thoughts on these?

Etienne Nichols: Yeah, what do you think of the modification protocol? I mean, is that kind of one of the ways they're suggesting getting around the actual data since you simply have the modification protocol that's being approved and assuming you pass that, that's the green light?

Mike Drues: Yeah, good question. And just as a reminder to you and our audience, I work as a consultant for the fda, so I see these issues on both sides. Just giving approval, approval based on a protocol without having data, I think it's going to be difficult for most FDA reviewers to swallow. Now here's my potential fix for that because I like to pride myself in making coming up with solutions, not making excuses. So what I would advise my customer, and this is exactly what I've been doing in the last year or so since we've been using these PCCPs, is include your protocol. But if you don't have the results, if you don't have the data yet, at least include the boundaries of your data so that as long as the data is between X and Y, it will be safe and effective. And therefore we can approve the PCCP even though we don't have the data yet. But in the absence of having data or at the very least having boundaries, you know, acceptance criteria, if you will, for that data, I don't see how anybody with an IQ of more than 5 can improve, you know, something like this. It just doesn't make any sense to me.

Etienne Nichols: Right, absolutely. So we kind of talked about the difference in the guidance documents. What about just impracticality using a PCCP for ML and AI versus a physical device. I mean, do you have any examples you want to kind of explore or what are your thoughts?

Mike Drues: Yeah, I think that again, I think the two guidances that we just discussed are essentially self, sorry, substantially equivalent. And in both cases we need to pre validate, if you will, these anticipated changes. It's not a blank check, you know, you can't just sign the check and fill in the number later on.

Etienne Nichols: Right.

Mike Drues: So the PCCP has to be filled out as much as possible. Here's a quick example, Eddie, and a customer that I'm working with right now. Remember I said before, the recent guidance expands this to the entire medical device universe, including in vitro diagnostics. So right now we are, and when I say we, my customer and I, we are having a discussion slash debate, if you will, because we want to use the PCCP to pre validate some additional labs that can do the analysis for this particular individual diagnostic sample. I don't see, based on my reading of the regulation or the guidance, I don't see any reason why we should not be able to use the PCCP to do that. However, because FDA has not seen this before, you know, they're obviously a little bit of hesitant. I'm optimistic. Again, I have to be careful here because this is a discussion that we're literally happening right now. I'm optimistic that we can address their concerns and we will be successful and probably the first one to set the precedent in this area. But again, this goes back to leader versus follower. You know, it's easy to get a PCCP to make a change that 50 other companies have already, you know, done a PCCP, PCCP for. If you're proposing making, doing a PCCP for something that nobody else has done before now, I think you're in the lead.

Etienne Nichols: When I came across this and people started reaching out to me maybe a year ago about how to utilize this for a device other than AI ML, because most of the people I speak with are not necessarily AI devices. And so they say, hey, is this possible to use? And my thought was, well, sure, I am not, perhaps I'm not creative enough to come up with sufficient examples that I think make sense to pursue. You know, maybe we could come up with some theoretical ones. And, and I've, I've got come up with a few, but I'm not satisfied that they're worth the, the, the juice. Might not be worth the squeeze in some cases, but I'm curious what you think.

Mike Drues: Well, that's ultimately, at the end of the day, Is the juice worth the squeeze? I love. Even though that might not be a politically correct metaphor today, I, I think it's an apropos one because part of the decision of whether or not the company wants to put together this pccp do, you know, develop the Met, maybe even start collecting a data to support a change that they may or may not implement in the future. That's a business decision. So one could make the argument that if you have a change that you definitively want to make, no question about it, then maybe a PCCP makes sense. But if you have a change that you're not sure about, maybe it's going to be dependent on funding or something else. Maybe you don't want to do a PCCP now because you could always do it as a label expansion later on. So there are a lot of different ways to, you know, to skin this proverbial cat.

Etienne Nichols: We talked about label expansion. You mentioned a few different things and I have a few thoughts on different things that could potentially change. And obviously the guidance talks about that. Can you talk about any limits on changes implemented through a pccp?

Mike Drues: Yeah, absolutely. One of the concerns that I have about the newest PCCP guidance that applies to all devices, devices and as a FDA consultant I've expressed my concern to the agency on this already is they make an explicit point that any changes that you make in your labeling, for example, have to be within the original indications of the clearance or approval. And my question is why? Because if you understand not just the letter of the law but the spirit of the law, in other words, if you understand the philosophical intent of the pccp, meaning, as I like to call it a pre validation, why can't I propose a label expansion, possibly even adding a new indication as a pccp? As long as I also include that pccp, the methodology that I'm going to use to, to prove it, and the data that I'm going to collect, or at least the boundaries of the data and so on. So I don't see any reason why, you know, you cannot use a PCCP even to change your high level labeling. Now also keep in mind, Ed Ian, that FDA said this in a guidance document and of course guidance is not binding. So I hope, whether it's me or somebody else, I hope that somebody pushes back on the agency and say there's no reason why you can't, you can't include a label expansion, adding a new indication even in a pccp, if it's done properly.

Etienne Nichols: So what do you think are the most beneficial uses for this?

Mike Drues: As with everything there, there are advantages and disadvantages. Theoretically a PCCP will allow faster label expansions and getting, you know, getting modified devices quicker to the market with minimal or no FDA involvement. But remember Eddie, and the first word I used there was theoretically because in the pccp, as we've talked about before, you still have to include the methodology to support that change. You still have to include the data. So that's going to take time and money to collect. So at the end of the day, I'm not sure, to be honest with you, other than maybe a couple of months of FDA review time, I'm not sure that the company is going to really save anything in terms of time and money. And as a matter of fact, I'm not even sure that the company is going to save anything in terms of the review time because a 510k with a PCCP is probably going to take longer to evaluate than a 510 without a PCCP.

Etienne Nichols: Right.

Mike Drues: So at the end of the day, you know, I'm not sure, again, to use your phrase from before, in, in all cases, if the juice is going to be, you know, worth the squeeze.

Etienne Nichols: Yeah. So if I. So if I just the argument from the other side, then let's talk about the AI side. You mentioned that as when you first kind of had the idea for an additional, I don't know what you called it originally. I haven't listened that. Yeah, how is that more beneficial with an AI device versus a physical device? And I'm going to caveat that question a little bit simply because we've talked about this a little bit in the past where you might have a device that the healthcare professional, the physician who is not regulated by FDA may make some additional changes, tweaks with knobs and different things. And so now the medical, or the medical device itself is anticipating those changes and just going ahead and making those for them. So that, that's kind of one of the examples of a physical product using AI or kind of a comparison. What are your thoughts there though? I mean, how is an AI able to be pre validated when another device may not be so.

Mike Drues: Good question. So first of all, when I refer to artificial intelligence here, I'm talking about what I call true artificial intelligence because I look at a lot of medical devices, and not just devices, but products in other areas that claim to have AI in them. But when I look at them as a professional biomedical engineer, I don't see any intelligence in them whatsoever, artificial or otherwise. So a true AI device is a device that is capable of learning and changing and evolving very much in a Darwinian evolutionary sort of a sense. Whereas a non AI device, dumb software or a physical device like a catheter or a breast implant or something like that, unless it's a modified by the physician, as you just suggested, that device is not going to change itself. I mean you could look at it for a million years, nothing's going to happen to it. So to get past this again, as I've characterized many times, this archaic concept of this locked algorithm, I suggested this pre validation model or now this PCCP model where we create boundaries. We say that the AI can make changes to itself without telling the manufacturer, without telling the FDA or anybody else. As long as those changes are between X and Y and we have validated the X, we have validated the Y and we validated a few points in between so that we know as long as the software remains within those boundaries, it's going to be safe and effective. Right? So that's basically the simplest way that I can explain it. Does that make sense?

Etienne Nichols: But even that, I guess I look at that, not to get too philosophical with the potential for artificial intelligence, to me it's all basically a spectrum of machine learning with just are your boundaries so far that you can't really tell where they are anymore? And so now we think it's artificial intelligence, when really. But that off the table, it still feels somewhat. I mean, let's go back to your Darwinian evolution and is it micro versus macroevolution? There's another discussion we could talk about. But even so, all that aside, I still, I think you could apply the same principle to even like an implant, we have a large size, we have a small size, and we've dilated a few points in between. And we're just going to make whatever size makes most sense. We're not going to tell you exactly the parameters. Fda, I don't know, in fact.

Mike Drues: Well in fact, Eddie, and that's an interesting example because I used exactly that same strategy probably five or maybe even six years ago when I originally helped to bring the first 3D printed knee onto the market in the United States. And what we, you know, ultimately what the company wanted to do was to allow the physician to print any size or shape of knee that they wanted because obviously that's the big advantage of 3D printing. However, from a regulatory perspective, I knew that was going to be a very difficult pill for the FDA to swallow. So instead what we did is we limited the 3D printing of the knees to initially two sizes of knees that we already have today so that they've already been validated, if you will. Then in step two, we go back to the FDA and say we can. We will now allow the physician to print knees as long as they're between sizes X and Y. And then step three of this label expansion is to go back to the FDA a third time and say, okay, you know, orthopedic surgeon, or whoever you are, you can now print any size or shape that you want. Right. So one of the challenges, and I, and I love that you brought that up, is the regulatory logic that I'm using here is exactly the same, even though I guarantee that nobody was using that phrase PCCP, you know, back five or six years ago, especially when it came to 3D printed needs. But that's the logic that we were using. One of the beauties of my approach to regulatory logic, Eddie, and you know, as we've talked about many times, is it's totally agnostic of the technology. In other words, I don't care if you're talking in this case about a 3D printed knee or a piece of software with AI or an in vitro diagnostic or whatever it is, you know, in spite of their obvious technological differences, the regulatory logic is exactly the same. I won't even say substantially equivalent. I will say exactly the same.

Etienne Nichols: Right. So I'm almost seeing that as a prime case where you could, had the PCCP been in place, maybe that would have made sense. Instead of saying, okay, we get to the point where we go back to the fda. Well, that to me is like, well, wait a second. Could that have been a PCCP modification protocol and you're ready to go back?

Etienne Nichols: We talked about some of the disadvantages and the different ways. Maybe we should go ahead and talk about how and when to submit a pcp. I'm kind of leading us far away on these rabbit trails. But how and when do you recommend people pursue this?

Mike Drues: So basically, in terms of the mechanics, the way that the PCC program is set up now and again, it's a relatively new program. There's not a lot of precedent. But the way it's designed or intended to work is the PCCP needs to be submitted as part of your overall submission. So if you have a 510k, if you have a de novo, a PMA, an HDE, whatever it is, you basically add on a PCCP section. And as a matter of fact, because I had a customer ask me this not long ago, FDA has not updated their website yet. Because if you look at the contents of the 510k or the de novo or the PMA, for example, there's no section in there for a PCCP, at least not the last time that I checked. So if you're going to include the pccp, it needs to be part of the submission. Now I strongly recommend putting it in as a separate and distinct part of the decision. Because remember, and for the sake of our discussion, let's just talk about a 510 that has a PCCP within it. It can very well be that the FDA is fine in giving you the clearance for the 510, but maybe they're not so fine about approving your PCCP. Well, if that's the case, I don't want the PCCP to hold up the rest of the train. I want them to be able to go ahead and clear the 510 and maybe in parallel to that we continue to work out whatever bugs there are in the pccp. I'm afraid that if manufacturers kind of co mingle the two together in the same submission, it's kind of like if they fail on one part, the whole ship sinks to the bottom of the ocean. So, so, so that's the quick how and when is that sufficient detail or do you want to go into that a little further?

Etienne Nichols: I think so. Maybe if we go just a little bit further, what would you say? Is there X number of changes? Yeah, I wouldn't go beyond this. Or, and how to make sure that it doesn't kind of stop the whole train like you mentioned?

Mike Drues: Yeah, great question. So another thing that FDA mentions in their guidance is there is no set number of changes yet you can theoretically include as many anticipated changes as you want. However, don't be surprised if that changes. I see the precedent has already been set in the pre sub world. You know, originally you can, you could ask as many questions within a pre sub as you want. Now FDA has put some limits on that. I see eventually the same thing happening with PCCPs. However, regardless of what FDA says or doesn't say about the number of changes, I would keep the number of proposed changes very small, as small as possible. You know, one or two or possibly three at the very most. Again, it depends on the regulatory burden of each. If these are relatively easy changes to substantiate and to make, then maybe three is not that much. But if it's a big change, for example, adding a new indication, as we talked about before, that's a big change, I probably would only include that. And if you are going to include more than one change, I would in your submission, I would not lump them all within one PCCP section. I would say here's my 510 submission, here's my PCCP number one submission, here's my PCCp number two submission, and so on. That way, if there are problems, we can focus on the problems with that one particular part and not the overall part. But at the end of the day, you know, Eddie, and keep it simple, stupid. The more potential changes that you list here, the greater the time, the greater the regulatory burden and everything else. So remember, this is not a panacea whether it actually saves the company any time or money. In the. In the long run, time will tell.

Etienne Nichols: Yeah, and I think when you talk about that 1, 2 or 3, it sounds so linear, but in reality it's just like having additional kids. Suddenly you have so much more room. Relationship dynamics, it's actually an exponential on the amount of work required. So that makes sense.

Mike Drues: That's a good point. And by the way, if you have, say, hypothetically speaking, a PCCP number one and number two and number three, are they dependent of one another or are they independent? In other words, before you implement PCP PCCP number two, you have to first implement PCCP number one. If that's the case now you're, you know, all these things are happening in series or in a linear fashion. On the other hand, if they're independent, you know, in their parallel, then that becomes less important.

Etienne Nichols: Absolutely. When you've asked me at the very beginning what the options are, so now we have a third option to the two, I suppose they still fall under the umbrella of disclosing to the fda. However, my mind thinks very hierarchically, if I can't pronounce that word categorically, and so on. So I think in a stepwise function, okay, if I'm a medical device company, it's kind of a small change. Letter to file is probably the, well, I shouldn't say the quickest and dirtiest, because you should. It's the same level of burden. You just simply haven't given it to the fda. It should be anyway. Most companies maybe don't do that, but you have this level, then you have a special 510k. Maybe you have, like I said, the PMA. I almost see this as somewhere in between, but I wonder if you have any thoughts on where you would see.

Mike Drues: Well, it is somewhere in between. I agree with you, it is somewhere in between. But here's the sort of caveat to that. Right now, the way that this PCC system has been set up, as we've talked about already, is the PCCP has to be submitted within a 510k or PMA or something else. My question, including my question to my FDA friends, is why? In other words, why do we have to embed the PCCP within a 510 or PMA submission? Why can't we have a mechanism where the PCCP is a standalone approval? In other words, let's say we already have a device on the market, we're not planning on submitting a new 510 or PMA for it. The company is thinking about making this change, but while in the process of thinking about it, why can't they submit a PCCP to the FDA to sort of pre qualify that change so that if and when the company decides to pull the trigger on that change, they've already had the conversation with the FDA and they're ready to go. So I see, and if somebody can think of one, please share it with me. But I see no logical reason why a PCCP must be contained with a within a new submission.

Etienne Nichols: I guess the only thing I can. I'm thinking through that a little bit myself and it seems as if the FDA would be looking at it with fresh eyes, as if they're looking at a new submission because they don't have the context of the original device. Of course they'd have to go get that. But it's almost as if what you're suggesting is it would rely. It would require the same level of rigor as a special 510k. Yeah, it's just after the fact, as far as when the company needs it. Yeah, I see.

Mike Drues: Well, I would like to think. I would like to think. And you use the special 510k as a comparator. I think it's a great comparator. I would like to think that, you know, even if FDA cleared this device five years ago or 10 years ago or 20 years ago, it wouldn't make any difference if they didn't know. They would go back and review that documentation because that's the same thing that has to happen if you submit a special 510k for a device that was originally cleared 20 years ago. So Again, I don't see any logical reason. If somebody can think of one, please share it with us. But I don't see any logical reason why we couldn't create a standalone pccp.

Etienne Nichols: Yeah, well, I think it's certainly possible. I am thinking of some of the more human aspects of our intelligence and that is forgetfulness. And you know, once we get to the point where we look at the database the way a computer does. Anyway, there you go. Any other thoughts on positives or negatives for this or practical tips when it comes to submitting a pccp?

Mike Drues: Yeah, great question to sort of start to close our discussion. And by the way, as I'm sure our appreciate, our audience appreciates we're just scratching the surface on this concept. I mean there's so many more things that we could talk about. But just a couple of final recommendations and words of advice. First of all, if you're considering a PCCP in nearly all situations, I would bring that up in a pre sub. That kind of goes without saying. Yeah. Although it will make your precept more complicated because now you're talking about not just your current device but your potentially modified device in the future. So if you're planning on bringing this up in your pre sub, and I've done it before, I would create a very distinct boundary align between the two. Even so far as to say for the first 30 minutes of the meeting we're going to discuss the current device and for the second 30 minutes or 15 minutes or whatever it is we're going to cost, we're going to discuss the potential modification via the pccp because otherwise you're going to get a tremendous amount of confusion as to, well, is this the current device, is this the future device? Yada yada yada, the PCCP should be very, very specific to that particular device, not some class of devices. If you're working on a catheter, for example, and your catheter comes in a particular length or diameter and you're suggesting that in the future you're going to offer a longer catheter or a shorter catheter or a thicker or a thinner catheter that that information needs to be included in detail in the pccgp. Don't leave it nebulous like, well, we're planning on making the catheter a little longer, but how much longer? Quite frankly, we don't know what, you know, what that's going to be, you know, because again, put yourself in the shoes of the reviewer. How can you possibly approve a product that is not Even at design freeze. Another way to think about this EDIEN is this is sort of a virtual design freeze. You're. You're asking FDA to approve a product that does not yet exist. So at least you've got to describe the product verbally. Focus on the changes that you would need to notify the FDA of, either via a special 510 or a PMA supplement. If it's a change that you can implement with via a letter to file, then I would not bother wasting my time with a pccp as long as you're confident that you can do it as a letter to file. Because as I said before, that's a reason why a lot of companies get in trouble. I talked about the dangers of co mingling the PCCP with the rest of the submission. I would create distinct sections and if you're going to have multiple PCPs, I would have section number one for PCCP number one, the next section for PCCP, PCCP number two, and so on and so on. And one last recommendation on the quality side, Eddie, and I don't think I've seen any company do this yet. Maybe this is something that Greenlight wants to think about for your QMS software. Maybe consider adding a section on PCCPs to your quality system. How you're going to implement a pccp, under what conditions would you consider, what would you need to provide to the fda, and so on and so on. So there's a little, you know, you could, Greenlight can sell a new module, you know, to add to the existing, you know, you know, for the pccp. So those are just a few, you know, of my final thoughts and recommendations. I mentioned a few of them in, you know, already and then a few of them new. But at the end of the day, you know, as I said at the beginning, I think that PCCPs are most valuable for AI devices for the reasons that we talked about before. I think PCCCs are potentially valuable for all devices across the board. But whether they, at the end of the day are going to save the company any time or money or any significant amount of time or money, that I'm not sure yet. But I'm glad that we have this new tool if you want to consider it new in our regulatory toolbox. And it's an important tool tool for all of our customers to be aware of and to consider as they're developing their devices and bringing them through the FDA and onto the market.

Etienne Nichols: No great summary. So I had actually thought in the past about design controls, how we have the must have and the nice to have and some companies will not get rid of that nice to have bucket. So we've figured out ways to try to put that in different places. But labeling it as a potential PCCP component might be interesting. I'll have to make that recommendation.

Mike Drues: And by the way, Eddie, and if we ever want to have a kicked up version, a more advanced version of this discussion, you mentioned design controls, one of the topics that are, you know, near and dear to my heart as well as you and the Greenlight folks. Well, what does anticipated use, sorry, anticipated misuse mean in the context of a device that is only proposed and has not actually been implemented yet? You know, what does risk management mean in the context of a device that is proposed but has not yet been implemented? So, you know, truly, you know, not to use too many cliches, but the devil is in the details. And I think it's going to be very interesting for, you know, our industry, including people like me, to try to meld this, you know, this concept of the PCCP into all of the other regulatory and quality regulations that we already have.

Etienne Nichols: Yeah, it will be interesting to see. And I, I have a poll out on LinkedIn. I'm asking, I'm trying to find somebody who's gone through some of this for a, some, some physical devices. So love to hear any thoughts. If you have any, feel free to reach out to Mike or myself. We'd love to hear more. And if you want a further discussion, if it makes sense, reach out to Mike or myself. Let us know. Love to hear from the audience and see what you all think. All right, Mike, thanks so much. I really appreciate you taking the time out of your day to share your experience and your knowledge here. Those who've been listening really appreciate you listening. If you want to learn more, head over to www.greenlight.guru, hit us up at podcastreenlight guru and send us an email. Let us know what you think. We'd love to hear more. And for now, everybody take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on itunes? I know most of us have never done that before, but if you're listening on the phone, look at the itunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.