Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, Jon Speer is talking to Mike Drues, who is a frequent guest on our show. He’s the president of Vascular Sciences and a guru on all things related to regulatory compliance for medical device companies.Jon Speer and Mike discuss a new program that’s just been announced. It’s a pilot program on accrediting test organizations. The potential is that test compliance will be more consistent and that the process will be streamlined. 

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Some highlights of this episode include:

• The background of the Accreditation Scheme for Conformity Assessment (ASCA): When it came about, when it should be implemented, and what it’s going to be used for.
• How current politics have impacted the development of this new program.
• Some of the challenges that the ASCA will likely bring about.
• The importance of asking the right questions and running the right tests.
• Thoughts on what to do if a regulation or a particular type of test is not appropriate or not possible.
• The potential pitfalls of putting testing labs into a position where conflict of interest is a real concern.

Links:

Greenlight Guru

Jon Speer on LinkedIn

Mike Drues on LinkedIn

Vascular Sciences

IEC 60601

ISO 10993

Memorable quotes from this episode: 

“The theory is that this will help streamline and expedite the workload of the FDA and make it easier for medical device companies to know what the FDA expects.”

“Some people try to separate regulation from politics, which makes no sense. Where do the regulations come from? The politicians.”

“If the regulation doesn’t make sense and we follow it anyway, is that a problem with the regulation, or is it a problem with us?”

Transcription:

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

Jon Speer: I'm glad you tuned in to this episode of the Global Medical Device Podcast, the guest on this episode is Mike Drues from Vascular Sciences, and Mike and I talk about this new program that's just been announced from the FDA, it's a pilot program on accrediting test organizations and the intent behind this is to potentially help streamline and improve the consistency from test compliance with respect to FDA recognized consensus standards. So, some pros and some cons and Mike and I talk about some of those on this episode of The Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast, this is your host, the founder the VP of Quality and Regulatory at greenlight.guru Jon Speer and I have my friend, a familiar guest voice you've heard often on the Global Medical Device Podcast Mike Drues, Mike is the president of Vascular Sciences and a regulatory expert, that works with medical device companies and regulatory bodies. Like FDA and Health Canada among others. Mike good morning.

Mike Drues: Good morning, Jon.

Jon Speer: Well you sent me a note the other day about something that we could chat about, and I must say that it was intriguing to me. So the topic is this new program that's sponsored by the FDA, where they're looking to do some sort of accreditation with testing firms and test organization. So, I thought we jump into that a little bit. So give me a little bit of background, what do you know about this program?

Mike Drues: So Jon, what you're referring to is officially being called The Accreditation Scheme for Conformity Assessment or the A-S-C-A, ASCA. This was publicly announced just a few weeks ago, but we've had some internal conversations about it at FDA for some time. If all goes as planned, it's supposed to be implemented by 2020 so just a couple of years from now. And basically what it means is to set up, at the moment it's a pilot program to set up this program to certify or to accredit various testing labs and agencies, such that when they do a particular test of a medical device as part of the regulatory clearance or approval process, then FDA will know that the test was done properly, according to the accepted methodology that the data was analyzed and so on. So that, quite frankly, FDA can then just accept the results, so to speak, without really reviewing it in more detail.

Mike Drues: The idea, of course, the theory is that this will help streamline that this will help expedite the workload of both the FDA and at the same time, make it a little easier for companies, medical device companies, in this case, to kind of know what FDA expects. So there are, similar programs to this in Europe and other places, in the world. That's in a nutshell what the idea is here.

Jon Speer: Yeah. There's a good article about this from RAPS and we'll be able to share that with the audience as well. But the way I understood it, really the scope of the program is for these accrediting some test labs and specifically focused on FDA recognized consensus standards, which that list is pretty large, and that seems like a big undertaking.

Mike Drues: It certainly can be and I don't see pragmatically speaking that this is gonna happen all at once, obviously, this is going to be an evolutionary thing, but before we get into the details, I can't help but interject. Why is it especially at this particular point in time that FDA is announcing this? It's not that I'm saying that it's a bad idea. We'll talk about that in a moment. I think it does have some advantages both to the FDA as well as to the industry but let's also be honest here, there's some politics. Because FDA... Let's put it this way, with the new administration in place and the new FDA Commissioner who just came on board literally weeks ago there's a lot of pressure to reduce the size of the agency to reduce the funding of the agency and from a political perspective, not to be cynical, but one could easily see this as a play to minimize FDA's workload. That is if a company has hired some other test lab to do a particular test, and they're certified, then it really becomes nothing more than a check box, a tick box on the form. This particular test was done, yes it was done by an accredited third party. Yes, the results were acceptable. Yes, move on to the next thing. So let's be honest, there is a bit of politics involved here as well.

Jon Speer: Yeah, well, that's an interesting... No, I guess when I first read this, I... I didn't see or really think about that spirit and trying to reduce the level of government, so to speak, with respect to the FDA, it seems to me, that this is going to actually potentially increase that. So how do you think that's... I know we're not clairvoyance per se especially when it comes to regulatory bodies, and what the FDA is doing, but I do appreciate the spirit in which, that this, the promise that this, this program holds. But at the same time, I'm a little uneasy about that.

Mike Drues: Well like everything, Jon I think there's good things and bad with regard to the political commentary that I mentioned a moment ago, it's not surprising that... That that was not mentioned in the RAPS article or at least in any other public sources that I've seen thus far because quite frankly, most people, especially in the medical world, they don't like to involve politics. In some cases, they don't even want to acknowledge that politics is part of our regulatory system. As a side note, I find it fascinating how so many people, they try to separate regulation from politics, which to me makes absolutely no sense because where does the regulation comes from? It comes from the politicians. That's not necessarily a bad thing or a good thing, but it is a fact. But anyway, back to the point of this particular program.

Mike Drues: I think overall there could be some advantages both to the FDA as well as to industry, but I see some challenges as well for one is... Well, let's put it this way. There are a lot of folks that view testing. And again, first of all, let's remember that medical device testing is a very broad term, it can include mechanical or bench top testing, like for example, strength testing or fatigue testing something like that, but it also can involve computational testing it can involve animal testing it can even involve clinical testing, so if this pilot program becomes acceptable, will eventually it be expanded, so that we can farm out, so to speak, our animal testing even our clinical trial testing to third parties. It's an interesting question that certainly takes us a step in that direction.

Mike Drues: Another thing to think about and, in my opinion as an engineer much more, it's one thing to talk about having somebody accredit the methodology and the data analysis, but who's going to be asking the question: Are we doing the right test? So many times in my world, Jon and I'm sure you've seen this happen, as well, where a medical device company brings a device onto the market under say the 510k they will just assume that they need to do all of the same tests for their particular medical device as the company that did the predicate before them. And I do not make that assumption because in some cases there are some tests that we need to do, in some cases there are some tests that we might not need to do, maybe we need to do something else. Maybe it's not applicable maybe it's not even possible to do it.

Mike Drues: So I have a problem as an engineer, when people approach testing methodologies as just sort of a tick box on a form. Did you do this test? Tick. Did you do that test? I'll share with you a quick example and then I'd love to hear your thoughts on this, Jon.

Mike Drues: One of the cool things about my job is I get to walk into lots and lots of different medical device companies, and one of my favorite questions to ask people in R&D or manufacturing or what have you, when I see somebody doing a particular test, a bench-top test for example, I'll ask them why are they doing this test? And more often than not, they'll say, "Because FDA requires us to do that test." I say, "Okay fine, fair enough, but if FDA did not require you to do it, would you do it?" "Absolutely not. It provides no use for valuable information."

Mike Drues: On the other hand, I walk into the same medical device companies and I see that they're not doing a particular test. And as a professional biomedical engineer, I think they should be doing that test, and I ask them why they're not doing that they'll say, "Because it's not required." So I have no problem having an accreditation system, a pilot program like this in place, but one of the questions that we need to always be asking ourselves, which we should not farm out on anybody is, are we doing the right tests? Jon, what are your thoughts.

Jon Speer: Well, it's, from being that, sitting in that engineer seat. I can understand both sides of that equation, I can understand. Well, I should be a prudent engineer and I should easily or definitely put my brilliant mind to work, and all those years of education and experience to work and identify the types of testing, and the types of standards that are applicable to my product. Sure, I get that, that's makes a lot of sense from a philosophical standpoint. And then I can also see the side where I'm a little conflicted.

Jon Speer: I want my submission to get through as simply and quickly as possible through the agency so sometimes, I may look at... Well, what did the predicate product do and what testing did they apply what standards did they apply and that becomes my list, my checklist, so to speak, which is as you noted, for several reasons, not necessarily the best practice. So I'm a little torn. And I think one of the things that seems to be driving some of this is, is the standards that we have in the industry today. They're not getting simpler: They're getting more and more and more complex and you have to become an expert in each of these standards in order to even understand what they're asking for, sometimes, which is crazy. So as an engineer, I'm trying to be an expert in this product or this technology that I'm developing now I also have to become an expert in all these crazy complex standards and it seems like every few months there's a new version of this and a new version of that, and a new standard for this a new guidance for that. How in the world can one keep up?

Mike Drues: Well, that's a terrific question, Jon, and let me come back to that in just a moment, with regard to the first part of your response in terms of taking the path of least resistance through the FDA, or through Health Canada or EU or any regulatory authority. Listen, I hear 100% of what you're saying, to quote a famous politician: I feel your pain. There are many times I have done a test or I've suggested to a company to do a test, even though I as a professional biomedical engineer, I think it is totally, unnecessary. Why? Because it's a test that we can do in a short period of time, in a little bit amount of money and then it just simply becomes a tick box on the form as opposed to having to go to the agency and saying, "Here's the test and here are the reasons why we're not going to do it."

Mike Drues: So one of the important lessons I've learned from my wife from being married, which I apply to my professional practice all the time is you have to pick your battles, if there's a test that you don't think is necessary, but it is something that you can finish in a short period of time for a little bit of money, it might be better to just simply do it to sort of suck it up, so to speak, and keep your political capital for a battle in the future worth fighting.

Mike Drues: On the other hand a couple of years ago, I had a device, this was in a different country, where they were insisting on us doing some pretty sophisticated biocompatibility testing that was gonna take probably about six months and cost hundreds of thousands of dollars. And most importantly, as a professional biomedical engineer and an expert in biomaterials I did not think that that was necessary. And this is a line where, this is a situation where we did draw a line in the sand and say, "Look, this is not necessary even though other people have done it before, for all of the following reasons... " So you do have to pick your battles.

Mike Drues: Well, coming back to your second point Jon in terms of the complexity of testing methodologies you're exactly right. In fact, one of the justifications for FDA bringing out this program is read to: "Many standards are highly complex and require a substantial specialized knowledge to interpret and imply correctly. This is a challenge for manufacturers and FDA alike." This is, as I said, directly from part of the announcement from FDA of this program.

Mike Drues: Well, with all due respect to my many friends in industry and at FDA, and this might sound a little blunt, or a little harsh to some, but I would say if somebody doesn't understand a test they have no business doing the test. Einstein, very smart guy. Einstein said, "If you can't explain something simply you don't understand it well enough." So, in my opinion, and again, this might sound a bit harsh to some people, but it's our job as engineers working in this industry, to understand how to best test our devices in order to show that they're safe and effective, in order to show that they will do what we plan to put on the label, and so on. So regardless of how simple or how complex it is, it's our job to understand that.

Mike Drues: And to your point about testing and guidances changing and evolving quickly. Well, that's probably a good thing because we don't want our testing methodologies to be stagnant, we want to continue to improve them. Is that a bit of a challenge for us to keep up? Perhaps, but that's part of the... That's part of our job. Don't you think Jon?

Jon Speer: Well, I'll say yes, and I'll say no. Yes, it certainly is our job to keep up with state-of-the-art, and I realize state-of-the-art is always evolving, so it is important for us to keep up with that. However, in my opinion, sometimes these standards when they're revised it doesn't feel like they're necessarily evolving to keep up with state-of-the-art.

Jon Speer: A good example, at least in my humble opinion, is the evolution of IEC 60601, the standard for electrical safety for medical devices. It seems to me that, that particular standard, over the past couple of editions has kinda gone the other way. It's created a lot of busy work and a lot of extra effort, especially around the area of risk management. And I realize that the people who write that standard, they've got a, a dubious responsibility to try to make sure that they've incorporated a ISO 14971 and best practices for risk management into that standard, but some of the practices that are now expected as part of that, that whole testing process become for many, many people I've heard specifically on that version of that standard is a little bit egregious and a little bit overly burdensome. So if, in fact, standards do evolve to keep up with state-of-the-art that's one thing, but if they're evolving to create more busy work that's a completely different thing.

Mike Drues: Well Jon, you're completely preaching to the choir on that one. I take the same approach to testing and consensus standards as I do to regulation in general, and that is if the testing or if the regulation makes sense then by all means follow it, but if it doesn't make sense and we follow it anyway, is that a problem with the system or is that a problem with us? So, if in a particular situation and I spend a pretty fair amount of my professional time doing exactly this for companies if in a particular situation, the testing doesn't make sense, or the testing is overly burdensome as you just described, then we need to go to the agency if it's here in the United States to the FDA for example. And I usually do this in the form of a Pre-Sub and I say, "Here's what the testing suggests but in our particular case, it's not appropriate." I probably wouldn't say it's overly burdensome, I would spin it a slightly different way.

Mike Drues: But I would say, "It's not appropriate or it's not possible for the following reasons, and here's what we propose to do instead." And by the way, a lot of companies will do that in actual submission in a 510k for example. Well, you're certainly allowed to do that. I would never do that because you might as well just put a red flag over your submission saying to the FDA, "Don't even waste your time reading this just kick it back to us right in our face." 'Cause you're gonna just about guarantee that your submission is rejected.

Mike Drues: So I always take things like this to the agency in advance as I said, usually in the form of a Pre-Sub, but it can be done in other ways as well to make sure that everybody buys into that. Probably one of the things that bothers me the most about this particular announcement Jon, as we start to wrap up our conversation and again, this is right out of FDA's announcement of the program, it says FDA will not review reports from accredited test labs except as part of a periodical quality audit. Or if the agency learns of new information relevant to a devices safety or effectiveness. Well, to me, we are really farming out a lot of the responsibility of the FDA here to a third party. And while, philosophically, that's not necessarily a bad thing, that's potentially problematic. It would seem to me because this is taking us first of all that's going to... It goes back to what I said earlier about politics.

Mike Drues: It really is going to reduce the workload of FDA which means they can do more for less money. So there's the politics, again, but more importantly, we're putting a lot of trust, a lot of faith in these accredited third party testing labs. At the end of the day, we are talking about people's lives here. In some cases, we're talking about putting something in somebody's body for the rest of their life, to save their life or something. So, maybe what we do and this is a suggestion we have not really discussed at least not that I know of, at FDA, maybe for this particular FDA pilot program at the moment, we take a page from the third-party review program and we limit it to low and perhaps moderate risk medical devices. In other words, for testing, that's gonna go into a class one or a class two device you might be able to use a program like this, but if you're working on a class three device, at least for the moment, until we get a little bit of history on this, we exclude testing, that would go into a class three. Is that a concern to you, Jon? And if so, what do you think of my potential solution to that problem?

Jon Speer: Well, let me start with your potential solution. First, I like the idea because that really de-risks the process or the potential behind this program and treats it as a true pilot. Let's start with those devices that can benefit the most. We're talking about a class three device, it's gonna go through PMA. I would want there to be a lot more control in place and a lot more scrutiny about what was done. So, I liked the idea of the class one and class two.

Jon Speer: As you talked about your point, the other thing that was coming to mind is one of the things that we're seeing actually now in the European community with respect to registrars and notified bodies and I will pose the question. It's really to be determined, I suppose, but one of the things that we've seen in that European model with registrars and identified bodies is just a few years ago, there were dozens and dozens and dozens of organizations who were qualified to be notified bodies, and registrars.

Jon Speer: And now what we're seeing is a huge contraction of the bodies that are certified and accredited to perform those particular task. And I wonder, if with this type of program that the FDA is posing, if we'll see a similar sort of thing, whether it'd be a lot of labs that now want to become accredited to this program to the FDA in order to drive revenue and those sorts of things. Just the control on this is something that is concerning to me, I guess.

Mike Drues: Well, that is definitely a concern to me as well, Jon and here's another not so hypothetical situation. I have several companies that I'm working with right now where we have to do a variety of biocompatibility testing and we have some very good biocompatibility labs doing the testing for us, but let's think about this for a second, as we put more and more responsibility in the hands of the testing lab. Is that not the proverbial putting the fox in charge of the hen house? In other words, most of these testing labs, they, let's be honest, their revenue is a function of the number of tests that they do. And so if we are going to try to justify not doing a particular test because it doesn't make sense, that means that the testing lab is not going to be making as much money because they're not doing that test. And so the potential for conflict of interest here is in my opinion not something that we can overlook.

Mike Drues: So look, at the end of the day, what it comes down to is one simple thing, regardless of how much or how little we farm out to testing labs or even to the FDA for that matter, the ultimate responsibility is on us, on the manufacturer, it's our product, the buck is supposed to stop with us. We should be responsible obviously, for what we do, but we should also be responsible for what we don't do, and why we don't do it. And let's put it this way... And you and I have talked about this before, Jon. I hear a lot of companies, they tell me they're afraid of the FDA. Well, a company should not fear the FDA, they should have a healthy respect for the FDA, but who should they really fear? The product liability attorneys, because those are the folks that can really impose some significant damage when we don't do our jobs properly.

Mike Drues: And I would argue that that's perhaps not an entirely bad thing because that's part of the medical check and balance system. So I think as we wrap this up, it'll be very interesting to see how this pilot program shapes out. I think as I said at the beginning, like everything, there are advantages and disadvantages. I think overall, the advantages could outweigh the disadvantages here, if we do it properly. And I think, as I just suggested earlier, limiting this at least initially, to class one and perhaps class two devices might be a way to kinda stick our toe in the water, so to speak, without diving in full force.

Mike Drues: But at the end of the day, it could be beneficial to the company, but I can't emphasize this enough, if you in your company do not have enough technical expertise to understand completely what your testing lab is doing and not just what they are doing, but what they are not doing, then I would suggest not to be self-serving, but you need to get somebody on your team perhaps not as a full time employee but as a consultant who does have more experience and also is not part of that testing lab to avoid that conflict of interest so that you have somebody with a little less skin in the game. One of the things that I pride myself on when I work with companies, and I know you do this as well, Jon, is I will be very honest with them and I will share with them exactly what I think that they need to do and exactly what I think that they don't need to do. And why, from an engineering and a biology perspective, and we work with the testing labs or we work with the FDA to make sure that eventually everybody is on the same page, we're pulling in the same direction. What do you think of that approach, Jon?

Jon Speer: Well, I like the approach. Folks, what it really comes down to is this is your product, this is a device that you're planning to bring to market and this is a device that is gonna help people and ultimately what we're obligated to do as medical device professionals is ensure that the products that we design, develop, manufacture and sell are there to promote and ensure the safety and efficacy of what they intend to do. And standards are really good, good things to embrace and understand because the purpose of a standard is, really, it's an accepted methodology behind a particular area of focus. I did mention the... For example, the IEC60601 electrical safety standard for medical devices. That's a great standard, don't mishear what I said earlier, it's a great standard because it describes accepted methodologies for demonstrating safety.

Jon Speer: Mike's made references to, a couple of times in this conversation, about biocompatibility a wonderful series of standards, ISO 10993 has been established as accepted methodologies for demonstrating biocompatibility. And again, these are all about safety. So, it does become a challenge, certainly for the medical device professional, you do have to understand the role that standards need to play in your device and in your technologies, and not that you need to become an expert but you need to be knowledgeable enough to know what the intent behind each of these standards are and how they apply to your technology. It is a big effort, that it is a hat that you need to wear as those who are out there developing new technologies and new devices.

Mike Drues: I think Jon, just to wrap this up from my side anyway, there's two final points I'd like to leave with our audience today.

Jon Speer: Okay.

Mike Drues: The first is following standards or consensus, existing methodologies is great, if that makes sense, but if it doesn't make sense, we need to figure out another way to do it. And so one of the concerns that I have about a potential program like this is who's going to be asking the question, who will determine if the tests are appropriate and so on. Just remember, once upon a time, everybody thought the earth was flat, the standard was that the earth was flat. And to just even ask the question, "Gee, I'm not sure, maybe the Earth is not flat," you would be considered a heretic, you could be put to death. So, a lot of people think that following a standard is it's the standard because it's the best or it's the right way to do something. In some cases, it may be but in other cases it may not. And we need to be asking those kinds of questions.

Mike Drues: Also following a standard is just about a guarantee that you're working on a me too product, if you're doing something that is truly new or novel, and we've talked about this before Jon, usually there are not standards to follow. And so what will be the... How will a third party agency like this certify a test like that, if we're coming up with the test, the standard ourselves. I don't think that's probably gonna be possible and I definitely want FDA to be reviewing that. So that's a... That's another criteria that I think should be excluded from this particular program, especially if FDA is going to take a more hands off approach to this.

Mike Drues: But the last quick comment that I'll make or just a suggestion, this is a new program, this is a pilot program. To their credit, FDA is looking for comments from industry on this. I highly recommend for the engineers in the audience who have comments or concerns about this to share them with the agency, either directly or a lot of times people do not want to, for the obvious reasons, share comments with the agency directly. So if you wanna do it a little more anonymously, feel free to contact me or perhaps to Jon as well, through Greenlight, and you can share your comments and we'd be happy to anonymously pass them on to the agency as well. Whether the comments are attributed to a particular source or not, I don't think it really matters. What's most important is, do you agree with the substance or do you have a specific concern, or a suggestion on how to improve the program? That's what matters most.

Jon Speer: Yeah, those are great suggestions, Mike. And folks, let me echo what Mike's saying. You do have a voice in this. As he mentioned, this is a pilot program, it's just been announced just a few days ago, so it's still a pretty fresh idea at this point, but the FDA does want your feedback and reach out to Mike, or myself, if you'd like us to provide that feedback on your behalf or feel free to do so directly. And we'll provide links to the latest greatest information on this pilot program that a company's... The conversation that Mike and I have had.

Jon Speer: The last point that I want to emphasize to folks is standards are important for sure, and as Mike mentioned, just because you're following a standard doesn't necessarily mean that you're state of the art. There might be something that's different, that's not captured in a standard. And so for your technology, especially if you're developing something unique and novel. So, all this really becomes part of an important aspect as you're going through the design and development process, understanding how standards fit in or whether they don't fit in, is certainly something that you should be describing and defining as part of your design input requirements, and that's an early step in the design and development process. I would encourage you to spend the necessary time to make sure your design inputs are as comprehensive and appropriate as possible for your technology, because it's certainly gonna drive whether or not standards apply in later stages and your development efforts, what kind of testing is required, whether or not you're gonna have to go to test labs or third party resources or whether or not this is something you do internally.

Jon Speer: So do keep that in mind and if you want a little bit of help learning how to better manage your overall design control process, including how to capture design inputs and how these help drive your verification activities, feel free to reach out to us at greenlight.guru. We have a software platform that's designed specifically to help you manage that particular process. And just go to greenlight.guru, request more information, we'll be happy to chat with you. I wanna thank Mike Drues, President Vascular Sciences for joining me again on the Global Medical Device Podcast. This is Jon Speer.

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