Explaining the Significance of Voluntary Consensus Standards

January 2, 2019

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What are Voluntary Consensus Standards? Why should you care about them? What role do they play in your regulatory submission process?

In this episode, Mike Drues of Vascular Sciences and I discuss the importance of such standards that affect medical device professionals.



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Some of the highlights of the show include:

  • Guidance and regulation are voluntary. You can comply or not. If something doesn’t make sense, justify why and describe what you plan to do instead.
  • FDA’s guidance document provides information on what standards it will accept and recognize. FDA doesn’t recognize all recognized standards.
  • There’s a correlation between consensus standards and regulatory pathways. The abbreviated 510(k) is the most important pathway for standards.
  • Declaration of Conformity: Provide proof/objective evidence. Companies need to have data/information available, but don’t need to include it in a submission.
  • Don’t assume that FDA reviewers are experts in your technology or standard. A company needs to be the expert that makes FDA reviewer’s job easier.
  • Standards are not hoops that you have to jump through. They can offer significant, strategic, or competitive advantages.
  • Standards that promote the safety and efficacy of your product should be followed, but many are becoming too complicated and don’t make sense.



Recognition and Withdrawal of Voluntary Consensus Standards

Recognized Consensus Standards Database

Latest Updates on CDRH Standards Program & IEC 60601

How to Prepare an Abbreviated 510(k)

ISO 10555-1:2013

De Novo Program

Mike Drues






Greenlight Guru


Episode quotes:

All guidance, all regulation is voluntary. We can either comply with it or not. - Mike Drues

Don’t follow (standards) blindly. Make sure it makes sense to what you’re doing. - Jon Speer

Don’t assume that the FDA reviewers are experts in your particular technology or in (a) particular standard. - Mike Drues

People think that standards are just more hoops you have to jump through. (But) there are some very significant, strategic, or competitive advantages. - Mike Drues


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: Voluntary Consensus Standards. What are they? Why do you care? What role do they play in your regulatory submission process? Well, I've got Mike Drues from Vascular Sciences on this episode of The Global Medical Device Podcast, and we dive into this topic, and its importance to you as a medical device professional.

Jon Speer: Hello and welcome to the Global Medical Device podcast, this is the host, founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. And today we're gonna talk about, I think a pretty important topic, and we'll dive into why I think that's important here in a few moments, but the topic is; What role do Voluntary Consensus Standards have in the medical device industry or medical device regulatory submission process. And when we talk about things regulatory, you guessed it folks, I've got Mike Drues with Vascular Sciences joining me today. Welcome Mike.

Mike Drues: Thank you Jon.

Jon Speer: Well, this topic of standards, I remember many, many years ago, when I was developing some of the first devices that I worked on, and I was discovering standards, it was like a new thing and I was like, "Oh, what is this? And why does it matter? And why do I care?" Because I was doing some testing, and things that were on benchtop testing, things that I thought made good sense and I realized, "Oh wow, there's this standard out there." And I was confused a little bit because I didn't really know what this all had to do with what I was doing. So, I guess probably a good first place to start is, What is a Voluntary Standard.

Mike Drues: Well, it is a good place to start Jon, and let's actually back up even more basic, What's a standard? So simply put, a standard is something that's recognized by somebody else or a group of people. It could be ISO, it could be ASTM, it could be FDA, it could be you and I. It could be just about anyone, anybody, and when it comes to a Voluntary Standard, all standards, in my opinion, are voluntary Jon, whether something says it's required or not, kinda like a guidance or regulations, as we've talked about many times before. I believe all guidance, all regulation, is voluntary. We can either comply with it or not, if it makes sense. But if it doesn't make sense, then we need to justify why we're not going to comply with it, and what we're gonna do instead. And so, the exact same thing when it comes to standards, I see lots of companies that I work with Jon, and I'm sure that you do as well, they will follow these standards for no other reason than simply because they are the standard. That's what they think somebody requires. Even when I ask them. Is that standard applicable? Does it apply to you? No, but they do it anyway. And in my opinion Jon, that's not an approach that we should advocate. What do you think?

Jon Speer: Yeah. Well, yeah, I tend to agree. Just going back to my own personal experience in it. There are a lot of standards that are out there, from a lot of different agencies. ISO, ASTM, IEC and there are many, many other standards organizations. But it's just don't follow blindly, and just, you make sure it makes sense to what you're doing. And I know we're gonna talk about that throughout our conversation today. But FDA recently came out with a guidance document, that has to do with FDA's recognition of consensus standards. So, I guess I'm curious, why do I care as a medical device professional about this newer guidance document from the FDA?

Mike Drues: Well, it's a relatively minor guidance Jon. It's in fact, it's very short, it's only eight pages. But the broader topic of standards, I think, is applicable across the board to our entire industry, because it's something that all of us have to deal with, no matter what kind of a medical device that we're working on. Basically, in this particular guidance, all it does is it provides a little bit of information on how FDA determines what standards that they will accept, that they will recognize, and what standards that they will not.

Mike Drues: It's important for everybody in the audience Jon to remember that FDA has said many, many times publicly over the years that they do not recognize all "recognized standards". And in my opinion, I strongly agree they should not. There are a lot of standards out there that to me, as a professional biomedical engineer, don't make sense. Or, the standard is too low and we need to raise the bar. For example, FDA has said many times that they will not recognize ISO standards across the board. Some ISO standards they will recognize and some that they will not. There is a database on the FDA's website. It's one of the 18 or so CDRH's databases that talk about, or that list the recognized consensus standards that FDA currently recognizes, and we can provide a link to that database as part of the podcast, Jon.

Jon Speer: Absolutely.

Mike Drues: But to me, this all is common sense, and I would actually ask or suggest that FDA to take that database a step further, I would like to have some information in there about the standards that they don't recognize and why they don't recognize them, because as a professional biomedical engineer, Jon, that would save me an awful lot of time.

Jon Speer: I tend to agree, and I know FDA has been doing quite a bit of work on this topic of Consensus Standards. I know at Greenlight we did a podcast with FDA on this topic a few months back, so we'll also provide a link to that so you can I guess learn a little bit more from an FDA perspective on this topic as well. But yeah, as a biomedical engineer, I'm trying to figure out what I need to know, but to your point, it's also maybe equally important of understanding what I don't need to know I suppose.

Jon Speer: But this topic of standards I think it seems to have... You and I have talked quite a bit throughout the 2018 about all the "changes" in FDA with respect to regulatory pathways and alternative 510Ks and special 510Ks and abbreviated 510Ks and all these sorts of things. But I know there's a correlation between this topic of Consensus Standards and regulatory pathways, but maybe we can elaborate a little bit on this. Which regulatory pathways to market are more important with respect to this topic of standards?

Mike Drues: Well, it's a great question Jon. And obviously, standards are important to medical devices across the board and by extension to all medical device pathways to market across the board, whether we're talking about 510K, de novo, PMA, HDE, CDE, what have you? But in particular... Oh oh, and just as an FYI, FDA has recognized about 400 standards specifically for people that are doing 510Ks to declare conformity, I'll talk more about that in a moment. But that the pathway, I think that is the most important when it comes to standards. It's the least commonly used type of 510K. It's the Abbreviated 510k or the... I believe is now calling the alternative 510K, which you and I have talked about in the past. The reason why this is the most important one when it comes to standards, is because the essence of the abbreviated 510K is very, very simple. All you have to show is that you're relying on a existent guidance document, or a special control or in this particular case, a recognized standard. And that's really all you have to do.

Mike Drues: And one of the questions I get from people when they're doing this kind of submission Jon, or if they're just simply relying on a standard for another type of a regulatory submission, do they need to submit the test data in support of that standard? The short answer is no. This is what we call a declaration of conformity. In other words, you can do this in one sentence, you can basically say, "I conform to ISO, blah, blah, blah or ASTM blah, blah, blah, or underwriters labs blah, blah, blah". Period and sign it and date it and that's all that's required. Now I don't usually recommend doing that because that would be the absolute minimum. I have several recommendations that I provide to companies. Do you think Jon, would that be supposed to go into here a little bit?

Jon Speer: Yeah, I think that's probably a good idea because... And let me share a story from my past on this topic too. Well, I was working on a Catheter project years ago, many years ago, and we had... This was more from the outside US lens, I suppose, but it's still, I think, relevant. The design history file of the project that I was working on was the scope of an ISO-1345 audit. And they were looking at standards that we had referenced during the design development of the project, and I had referenced... There's an ISO standard for Intravascular Catheters, I think it's ISO-10, 10555-1 10555-1. And one of the criteria in this standard was about essentially tensile test, or strength test of any bonds within that Catheter. And my testing, my verification testing, I had cited the methodology that's described in that standard and basically showed that we met the criteria. And then the auditor did something that I was not expecting. He went through every clause within that standard and ask where my proof or objective evidence was for each of the different clauses. So I thought I'd share that story, because I think it's pertinent to this topic of declaration of conformity.

Mike Drues: Well, I agree it's part of the... Jon, it's a great example, thank you for sharing that. And definitely when it comes to an FDA audit, the company needs to have that information, that data available. And definitely when it comes to... What I was referring to a moment ago, when it comes to a regulatory submission like an abbreviated 510K, the company definitely has to have that information, that data available. The question that I was sort of getting into is, do we need to provide that data as part of the submission?

Jon Speer: Right.

Mike Drues: And as I started to explain, the short answer is no, absolutely not, at least not necessarily. But you do have to have that information available upon request. So here are my recommendations, Jon, because this is an area that I get questions on from people a lot and I suspect you probably do as well. First of all, don't assume that the FDA reviewers are an expert in your particular technology or in this particular standard. So the first thing that I like to include is what the standard is? Why it applies to our particular technology? And by the way, I always try to provide a reference to that particular standard, if they are not familiar with that standard, or if it's been quite some time since they've reviewed it. And don't even get me started Jon about this business of how many of the ISO standards are copyrighted and you can't just simply provide a link. I mean I think that's ridiculous, but that...

Jon Speer: Yeah. Yes. And folks, let me just elaborate a little more of what Mike's saying, because I get these requests all the time. Like, "Hey, can you give me a copy of ISO blah, blah, blah, standard or IEC standard?" Folks, as much as I would love to, I cannot. Because these are a fee-for-service sort of thing, you have to pay for these on your own, which, as Mike said, that's a whole different topic for a whole different conversation. But it's crazy.

Mike Drues: Yeah. I just think it makes our jobs much more difficult Jon. And one of my philosophies when it comes to FDA reviewers is I wanna make their job as easy as I can. So if they're not familiar with a particular standard or if it's been quite a long time since they've looked at the details of that standard, I would like to be able to just provide a link, "If you're not familiar click on this link and here are the details." But anyway, that's probably not a problem that you and I are gonna solve today.

Jon Speer: I would suspect no, we are not. But it is an interesting point because I'm trying to convey to FDA why this standard applies to my product, it's somewhat of rhetorical question, but how can I effectively do that? When I'm not allowed to actually share that standard as an appendices or a reference. I have to hope or assume that that FDA reviewer is A, either familiar with this standard that I'm referencing already, or B, has access to the latest greatest version of that standard too. So it is a bit tricky, but I'm sure this is why your recommendations are gonna be appropriate for those listening.

Mike Drues: Well, first of all, FDA obviously does have access to the details of standards. I would just like to make that process easier. And I have heard tell Jon, I'm not necessarily saying that I have done this or I advocate this, but I have heard that some people will actually include a standard as an appendix or something as part of their submission. Whether that violates any copyright laws or something, I'm not sure. But anyway there are ways that we can ease the burden, so to speak. My next recommendation, and this happens a lot as well, if you're following a standard, if you're doing a test without any changes to the test methodology whatsoever, then all you need to do is say, "We're following this particular standard end of discussion." However, that doesn't often happen most of the time, because of the device under development or the technological differences. The company may have to make some changes or modifications to that particular standard. That's not at all a problem, but what you do need to do, and I always do this in advance of the submission Jon, in the form of a pre-sub, you do need to say, "We're gonna be following this particular standard, we're gonna be following the methodology as written with the following changes or modifications. And oh, by the way, here's the reason why we're making these changes or modifications".

Mike Drues: And the reason why I always share that with FDA in advance Jon, is because if there's gonna be a question, if there's gonna be a concern or an issue, I wanna find out about it sooner, I don't wanna find out about it at the point of the submission, and then they have the submission rejected because they don't understand why those changes or modifications were made. The next recommendation I have is to make sure that you can explain why that particular standard applies, based on your technology. And what I like to do John, is I will sure up my arguments not just with what I say, but I love to include letters from subject matter experts. And when I do this, and I do this a lot, especially in pre-subs, I will ask somebody, usually from academia, the Chair of Biomedical Engineering at one of the good universities or a surgeon, or it depends on what kind of a subject matter expert you're looking for. But the first thing I say to them is, "I do not want you to say anything about our particular device, and I certainly do not want you to say our device is the greatest thing since sliced bread." Because that's inherently biased.

Mike Drues: When it comes to standards I would ask somebody to say, for example, the chair of Biomedical Engineering at Hopkins, just to pick an example. For them to say, based on my understanding of the technology of the device under development, it makes sense to me as the chair of biomedical engineering, to apply this particular standard to assess the safety, efficacy, performance of the device, and so on. So I wanna make sure that I show my friends at the FDA, it's not just me that's saying these things, it's other people subject matter experts that agree with me.

Speaker 1: And the last recommendation, and I had this question come up as part of a pre-sub that I was doing at FDA just a few weeks ago. Sometimes companies in order to save some time or to save some money, they wanna do the testing themselves. And sometimes they wanna do it not under GMP or somehow other regulated conditions. That's not necessarily a problem, but you do need to explain to the FDA again in advance, ideally in the form of a pre-sub, who's going to be doing the test. You're gonna be doing it yourself, in your company or you're gonna be farming it out to somebody else. And especially if you're not gonna be doing it under GMP, why you're not gonna be doing it under GP.

Mike Drues: This is a topic of a whole different discussion Jon, perhaps we'll have a future podcast on both the justification, not just of the testing that you're doing, but who's doing it and how it's being done. This is one of the most common reasons why submissions are either delayed or flat out rejected by the FDA. And it's another one of these areas where unfortunately these kinds of problems are almost 100% preventable, by doing these things in advance.

Jon Speer: Yeah, yeah. Folks, these are really simple things, but obviously Mike is mentioning them because, just because they're really simple things and what seems to be in the category, the bucket of common sense, they're not applied all that often sadly. And to Mike's point, these are just simple things that you can do that are completely avoidable early on in the process and you need to put in more way or credence into the value that a pre-submission can bring to your process. So all this aside, are there some strategic or competitive advantages for me to engage or consider the use of standards?

Mike Drues: Absolutely. A lot of people think that standards are just more hops that you have to jump through. I'm sorry, I just don't look at it that way. There are some very significant, strategic or competitive advantages. And I'll just remind our audience of two examples. The first is, we talked a little bit about the 510K and specifically the abbreviated 510K a moment ago. Well, one of the big advantages of a de novo, if you end up doing a de novo as opposed to a 510K, is that you get an opportunity to let me say influence the FDA, as to what new special controls, what new standards if you will, will be created as part of that new product code. And if you designed those tests correctly, you can design them so that they're favorable to your product, but at the same time it makes it more difficult for your competitors to match. And that's a very sophisticated use of regulation, you and I have talked a little bit about competitive regulatory strategy before Jon in some other podcasts. That's a very savvy use of regulation in my opinion.

Mike Drues: The second example, of how we can use standards to our advantage. I have a few companies that I work with, where they have folks who are sitting on various committees at ISO or ASTM or so on. And when it comes to developing or adopting new standards, they have inputs, in some cases are quite a bit of input as to what the standards look like. So if you're sitting on one of those committees, and you can have some influence, of course your competitors may be sitting on those committees as well, but if you have some input as to how those standards are written, once again that can be a very significant competitive advantage for you, and at the same time a competitive disadvantage for your competition. Does that make sense Jon?

Jon Speer: It totally makes sense. And I actually encourage folks to try to participate in these activities. For me, for one, there's many, but for one simple reason, there are some of these standards Mike, and again, a different topic for a whole different conversation. But there are some of these standards that in my opinion, are getting to the point where they're extremely unwieldy and it's definitely not practical, and I think they're getting to a point where the standards writers are, they're making things significantly more burdensome than they need to be. Yeah, I understand we have an awesome responsibility in the medical device industry to make sure that the products we develop are safe and effective and meet indications for use. And I understand the role that standards play in this process, but there are some of these standards, and I won't name them right now, but there are some of them out there that are... It is crazy how ridiculous they are in my opinion.

Mike Drues: Well, Jon I could not agree with you more and regrettably, I have to say, every single week, in some cases every day as a regulatory consultant, but more importantly as a professional biomedical engineer, I read regulation, I read guidance, I read standards that make absolutely no sense, and yet people follow them anyway. And that's in my opinion, that's a significant problem. It's the adage the surgery went perfectly but the patient died anyway. Well, it's the regulatory equipment. We followed the regulation perfectly. We did all that FDA asks us to do and yet the patient died anyway. Unfortunately, these problems happen more frequently than some people would like to think. So perhaps we can wrap this up Jon...

Jon Speer: Yeah, sure.

Mike Drues: And get the few final thoughts and recommendations. And I'll start out, first of all, companies obviously should be aware of the standards that apply to their particular technology, but as I said earlier, don't just follow them blindly. Consider them like guidance or any regulation. They are recommended but not necessarily required. If you're not going to follow that standard for whatever reason, you do need to justify why. And in my opinion, although the regulation doesn't say it, your justification should not be shared with the FDA for the first time as part of your submission. There's no better way to get your submission thrown right back in your face than to do that. What you should do is take it to the FDA in advance of your submission, whether it's in the form of a pre-sub up or something else, I don't really care.

Mike Drues: Another thing to keep in mind is when you're meeting the regulatory requirements or when you're meeting a particular standard, that's the academic equivalent of being a C student. That just means that you're passing. That does not mean that you're making a safe and effective product. That certainly doesn't mean necessarily that you're making a good product. So our goal as an industry should not be simply regulatory compliance, or quality compliance, or meeting a particular standard. I think we can really set the bar a little bit higher than that.

Mike Drues: As I said earlier, another recommendation is not simply to justify what you're doing or what standards you're following, you should also justify what you're not doing and what standards you're not following. When I go into the FDA, Jon, and as you know, I'm down there pretty frequently at least once a month, sometimes more. I will explain to them not just what I'm doing, but I will also tell them what I'm not doing and why I'm not doing it. Most people don't do this, Jon, but this is why most people's submissions are rejected, because I wanna take away every possible opportunity I have for FDA to disagree with me. And use the opportunity to create new standards to your advantage, whether you're doing this as a de novo or as a PMA. Whether you're serving on a standards committee, there are some significant advantages of being able to do that, because there is an existing standard that applies to your device or your technology. Remember, you're probably not doing anything new, because one of my definitions of newer novel is that there is no regulation for it, there is no guidance for it, there are no standards for it, there is no reimbursement for it. So that's something to think about.

Mike Drues: And last and perhaps most importantly for our audience, Jon, and I would love to hear your thoughts on this as well. When it comes to your device, when it comes to your technology, when it comes to the standards that you're gonna be following and the standards that you're not gonna be following, the company should be the experts, not the FDA. You, as a company, should know a heck of a lot more about your technology and your device than the FDA ever will. And for Pete's sake, never go to the FDA and ask them what standards apply or don't apply to your particular device. With all due respect, that's your job, that's not the FDA's job to tell you. And I had a friend of mine, just the other day, one of my very good friends who was an FDA reviewer shared with me yet another story. He said he had somebody come from a company, and basically they said, "We're developing this device. It works this way. Can you please tell us what standards apply?" It's like, "Did you go to engineering school? Did you do your homework?"

Mike Drues: So it's a sin on my mantra that I've mentioned many times before, Jon. When it comes to FDA, tell don't ask, lead don't follow. And that this applies to many things including standards. So that's just a few of the final thoughts and recommendations that I wanted to share with the audience. If you have any other examples or any other recommendations, please feel free to share them.

Jon Speer: You know, Mike, I appreciate the insights on this topic. And folks, I would just wrap this up with this thought. Understand that standards can have... In many cases, should have a role in what you're doing as a medical device professional. And there's a lot of importance for a variety of different products that will support your regulatory rationale, your regulatory submission. And there's a few tips that you should all leave with is become that expert, understand what your product does, understand if there are standards that are applicable to your product. And in the case that there's not, be prepared to define the methodology, the testing criteria, whatever the case may be, to demonstrate that that product is safe and that it meets the indications for use. Because this is the big picture, standards are here. The big picture intent of a standard is as we talked about earlier, is it's an accepted way of doing something. And the bigger picture above that, is that the idea behind this is that it's really about promoting the safety and efficacy of your product.

Jon Speer: So understand that that role that standards play, but don't just do it blindly. You have to become that expert in your product and what applies, what doesn't apply, and just tell your story, explain to FDA and other regulatory agencies, the story of your product, what it does? What it doesn't do? Why it does this? Why it doesnt do this? And support it with standards and other methodologies that you've employed during the design and development of that. So, Mike, thank you so much for your time today and enlightening our audience on the role that Voluntary Consensus Standards have and the Medical Device Regulatory Submission process.

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

Jon Speer: Alright. And folks just a reminder I've been talking to Mike Drues with Vascular Sciences, he's an expert in all things Medical Device Regulatory related. So at any point in time if you have a question, you can always reach out to him and contact him. I know he's happy to help you with your strategy and provide a little bit of clarity to this jungle of regulatory issues and challenges that are in front of all of us in the med device space these days. And of course, understand that a lot of what we're talking about today... Have been talking about today, on the topic of standards, this is part and parcel with your design and development efforts, things that you should be addressing as part of your design control, in some respects, your risk management of your medical device product development efforts. And this is a big part of what we do at Greenlight Guru. We have developed a medical device-specific software solution designed by medical device professionals. And there are workflows to manage all of your design and development activities, your risk management activities, and it ties into your entire quality management system.

Jon Speer: So if you need a little bit of help, and a little bit of guidance on simplifying the process and holding it all together, I would encourage you to go to www.greenlight.guru to learn more. As always this is the host of the Global Medical Device podcast, founder and VP of quality and regulatory at Greenlight, Jon Speer.



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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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