scott-and-leo-podcast

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA’s CDRH standards program? Consensus standards database? FDA’s ASCA pilot program?

On today’s episode, we have Scott Colburn, Director CDRH Standards and Conformity Assessment at FDA, and Leo Eisner of Eisner Safety Consultants to discuss what’s currently happening in the medical device industry when it comes to standards.

 

Some of the highlights of the show include:

● New versions of IEC 60601 are in the works; every five years, standards are reviewed to address collaterals, issues, and recommendations.

● Policy updates have been made regarding the appropriate use and recognition of voluntary consensus standards.

● FDA values such standards because of consistency, predictability, and credibility of science-based decisions around patient safety.

● FDA trains staff on standards and provides the medical industry with information on how to use FDA’s programs - working together to improve use of standards.

● Guidance is updated to be more efficient, consistent, and nimble: Process of recognizing and withdrawing standards.

● Describing the changes made regarding declaration of conformity vs. general use of standard.

● Some changes to standards are significant and affect requirements, such as updating normative references.

● Declaration of Conformity is a legal statement that shows you followed a specific path and applied a standard in accordance with its intent.

 

LISTEN NOW:

 

Like this episode? Subscribe today on iTunes or SoundCloud.

 

Links:

IEC 60601

Center for Devices and Radiological Health (CDRH) Standards Program

Recognized Consensus Standards

Scott Colburn

Division of Industry and Consumer Education

Eisner Safety Consultants

FDA Guidance Document on Voluntary Consensus Standards

FDA 510(k) Submission Process

FDA’s ASCA Program

Greenlight Guru

 

Quotes:

“ I still get twisted and tied up and confused from time to time on standards.” - Jon Speer

“Writing a standard takes quite a bit of time, effort, energy, and pulling a lot of resources together.” - Jon Speer

“The importance of standards cannot be understated.” - Scott Colburn

“Our agency really values voluntary consensus standards because of consistency, the predictability and the credibility that they give toward making science-based decisions.” - Scott Colburn


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:                     Standards. Standards. Standards. Oh my goodness. These things seem like they're changing and evolving all the time and it seems like its impossible to keep up with what's going on. I mean, are you up to speed with the latest, greatest on IEC 60601? What about the FDA CDRH standards program, do you know what's going on with that? And what about the updates to the standards database? And this new ask a program, pilot program that FDA will be rolling out? Oh my goodness, so much going on in this space. And that's why I'm thrilled to have Scott Colburn with FDA and Leo Eisner with Eisner Safety Consultants 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 and VP of quality and regulatory at Greenlight Guru, Jon Speer. And I'm pretty excited about this podcast because, you know, it addresses the topics that, my goodness that's confusing for those of us in the medical device industry trying to bring new products to market, and align with all of these standards and guidance out there. So I have two experts on today's podcast. And we're gonna talk about the latest updates on CDRH standards programs and IEC 60601 Series. So joining me today, I have Leo Eisner. Leo is the Principle Product Safety and Regulatory consultant at Eisner Safety Consultant. I refer to Leo is the IEC 60601 guy, so you can call him that too. So, Leo welcome!

Leo Eisner:                    Thanks Jon, appreciate it. Its good to be back.

Jon Speer:                     Alright, and I also have joining us, Captain Scott Colburn. Scott is the Director of standards and conformity assessment program at FDA Center for Devices and Radiological Health. So Scott, welcome to the Global Medical Device Podcast!

Scott Colburn:               Thank you Jon, glad to be here.

Jon Speer:                     Alright, and I thought we would just dive in because, you know, I've been doing this for a long time. And even though that's the case, I still get twisted and tied up and confused from time to time on standards. And one of the biggies, especially for a lot of products out there these days is this 60601 standard. And I know Leo, you've got that standard memorized. I don't know how many pages it is today, but I now you're the world's expert on that standard. But you mentioned that there's a draft of 60601-1, Edition 3.2 along with some additional collateral standards in the works. Can you talk about what's going on with this standard and all the ancillary parts and pieces to it?

Leo Eisner:                    Sure Jon, appreciate that. There's a couple of things I need to sort of define up front before I get into the details a little bit, because otherwise I'll be repeating long terms and stuff. So, one thing is we have a short list project, which is now also called the amendments project. These are the issues that are being dealt with in the draft you just mentioned, edition 3.2 or third edition with amendment 2, and the associated collaterals. Collaterals, for those that don't know, are 60601-1-XX, like 1-2 is ZMC, 1-6 is usability. Then, there's the long list project, which will be the fourth edition of 60601, and yes that's way in the future, its probably 2024 or later when it starts officially. Then its lots of acronyms which I will try to explain as I go through things.

Leo Eisner:                    So, the progress goes back to 2015 in Kobe, Japan we met. And 62A which is the sub-committee under TC62, which is the technical committee, or the mothership, issued a resolution. And that resolution, the basic concept was how are we gonna figure out of these 500+ issues that have been collected, what's the criteria that's for the short list vs. the long list projects? And that was a long process. Also, how are we gonna vote as national committees? And lots of other details.

Leo Eisner:                    Jumping forward a little bit, in Daytona, FL, the CAG, the Chairman's Advisory Group for 62A, which I'm not on, the members of the CAG reviewed these 500+ items and tried to do a baseline sort. These are shortlist projects, this is long list. Then we had to go to the national committees, and then Frankfurt, about October of 2016, 62A had a meeting and we had a live vote. Took a day and a half to go through those 500+ items. We took 2 to 3 minutes per item to vote. It was insane.

Leo Eisner:                    The applicable maintenance teams and working groups out of that vote were determined for the short list project. And we were on our way to writing the first committee draft, which is the first step in the process for existing standards.

Jon Speer:                     So, what you're telling me is, writing a standard takes quite a bit of time, effort and energy and pulling a lot of resources together.

Leo Eisner:                    That is an understatement and one thing that's really bad about standards development that I see, its a lot of graying of the brain trust. And there's not a lot of replacement on the front end. So, we're losing people, not gaining people in a lot of cases. Cause a lot of companies can't afford to have someone to go to all these meetings. You know, there's the ANY costs, the ANTSY costs for US membership to be on the committees. Then there's all the travel costs and the time and the expertise, outside the meeting and inside the meeting. So, its very expensive for companies and its a challenge for me too since I'm self supported.

Jon Speer:                     Yeah, so I mean obviously standards, you know they change from time to time and I assume many times standards are changing to keep up with what's state of the art. But Leo, do you have some idea or, can you provide some explanation for why are we seeing the changes to the 60601-1 and collaterals? Why is this happening now?

Leo Eisner:                    The basic reasoning thing is that we did amendment one of third edition around 2012. And that was the 83rd edition cause there was a lot of confusing aspects of it. When amendment 1 is significantly better than 3rd edition, and I always say that, and I think FDAs agreed to that. And OSHA agrees with that a lot. So, at the end of 2015, the secretary said we're cutting off all future input at that point, and we're gonna start looking at what is amendment 2. Because we want to start planning things. So the line was drawn in the sand for the short list projects, for issues coming in. Other than there's a couplet hat have been added in since, but those were urgent issues.

Leo Eisner:                    Input submitted to the secretary included content generated. They did a- every five years we do a systemic review of standards. So we did the general standards success 60601-1 and the collateral standards. And that was done by the national committee skipping input in the voting system NIAC And the working group, 14 recommendations added, is part of this, which was the interpretations group. That have posed, there were certain issues that were published which I think were up to item 230. I'm a member of this group as well. And this is one of the working groups in the short list project.

Leo Eisner:                    Then, issues were collected by the secretariat, of the 62A secretariat, and also conveners over the years. And lastly, open issues since amendment 1 were happened. The output of the national committee during the Frankfurt meeting, which I mentioned briefly, was the short list vs. the long list. So the criteria for the short list project included five items. Safety gaps, problems for regulatory bodies, inconsistencies within the 61 series of standards, especially the general one, collateral is a short list project focused on, technical errors, and the update of key standard references. And the line in the sand for the long list project hasn't been set yet.

Jon Speer:                     I see. Alright. So, Scott, I'm always curious too. You know, obviously thank you so much for joining us today. Its always great to hear the agency's perspective on these types of topics as well. I know there's been a ton of work, I'm sure you've been very involved and your teams been very involved. And the consensus standards database and information. But are there any policy updates on the appropriate use and recognition of these voluntary consistent standards at FDA?

Scott Colburn:               Yeah Jon, there's been really a whole series of updates. And I'll walk through some of them. But I want to echo Leo's sentiment about the importance of standards cannot be understated. From a regulatory agency, even at just the national level, but more importantly when we're working with global standards, the global use of the regulatory authorities is also paramount and very important. And that's kind of where a lot of the updates of our language that we put in the appropriate use voluntary consent standards guidance comes from.

Scott Colburn:               In the end we're really trying to show you know our agency really values voluntary consensus standards because of consistency, the predictability and the credibility that they give towards making science based decisions which helps support how do standards for them to a regulatory agency ability to make an appropriate regulatory decision that's designed around patient safety. And for all these things about standards that are about becoming a key aspect to this, one of the things we really want to show is that we are really committed in, to ensuring that standards are high quality and can be used for regulatory purposes. And FDA is one of the leading fronts in doing this in the medical device sector.

Scott Colburn:               But in general, just about how government participates in standards, we sent out over 650 different committees and working groups at the national and international level. We have over 350 expert liaisons just in CDRH alone that sit on those on a number of different specialties and standards across the agency across all the different modalities and processes that you can imagine. So its quite a commitment. And it takes a lot of work, and we don't really see that in the development of these processes and products. And because of that we also want to be a part of the ability to help some of these and lead some of these and work with our stakeholders across the industry and academia as well as the patient advocate that are part of the process. So we become very important.

Scott Colburn:               To give you kind of an outline of what our guidance document is about, it really stems right off the roots of the program that's designed under the Food and Drug Modernization Act back in 1997, which gave us that authority to formally recognize a standard, either in all or in part, and added the ability for us to accept the formal declaration of conformity to recognize standards. And that becomes very important because that allows us to have a dialogue with our sponsors by saying we feel pretty confident about these standards, and we'll accept the declaration of conformity, with the appropriate supplementary information as dictated by the standard skills and the way that the test methods and results are indicated in such standards. It gives us the opportunity to lower the regulatory burden but also to lesson the burden for to our sponsors on how they describe, how they met certain aspects of testing, and to give us that nice confidence in the fact that they're using these standards to help outline a bigger picture towards the safety and performance aspects of devices.

Scott Colburn:               21st century chairs back in 2016 give us a really big lift for us to communicate a little bit more about what it means when a standard is recognized. And one thing is it allows us to now  communicate our determination and rationale and purpose for why we are recognizing standards, whether complete standards. But more importantly if there's a part of a standard we don't recognize, we're allows to describe a little bit about what is it that prevents us from recognizing that complete standard that we can communicate to the user of the standard, we have a better chance of getting that first time testing correct without going back and forth for additional information and clarification.

Scott Colburn:               And so the 21st century allowed us to do that. But also made sure that we are training our staff on the appropriate use of standards, as well as providing industry the right piece of the information and education, so they understand how to utilize our program. So the agency is unveiling a series of different CDRH modules online, as well as updating guidance documents, and doing outreach such as this to just try to inform all of our stakeholders including our sister agencies within the US and sister FDA CDRH's across different countries and regulatory authorities who all kinda work together to try to improve our overall use of standards.

Scott Colburn:               So to really try to get to the meat of what are some of the big changes that were done? Going to the whole foundation of what's in our recognition database, we have what's called supplementary information sheets. And these are documents that we have, one for each standard that's recognized that lists the pertinent information to help a sponsor, as well as the review stuff, to understand how that standard fits into its support for the Declaration the Conformity outlined by FDA's recognition.

Scott Colburn:               And what we've done with the 21st century chairs and the appropriate use guidance is added in a few things to help make it a little bit easier for a sponsor to figure out is this standard is the appropriate standard for us to use before they may even have a chance to purchase that standard. So simple things like adding the scope of that standard as well as the rationale for the recognition, or non-recognition, or part of the standard is being added. And you know, not to just only add things, but we also removed a lot of aspects from those two editions that we felt were no longer necessary. And so, removing certain things like, what the device was effected by the standard, what are the processes effected, or what's the type of standard. That's usually described right into the scope of the standard anyway. So its right upfront in the more, in the better defined way which is the intent of the standard is designed. And so, from that we're able to take up along and go into describing better in how the standard is designed to do. And I want to just highlight three areas that this guidance really kind of updates that changes from what we'd be doing in the past, to be a little bit more nimble and a little bit more efficient in how standards can be useful for both the regulatory side as well as sponsor submitting.

Scott Colburn:               The first one is discussing FDA's intent to recognize a standard. In the past, we have always waited on the publication of a federal registered notice that sometimes comes out, maybe two times a year, maybe if we're lucky we can get three or four out in a year, but it's never predictable. We never know how long it's gonna take to get through all those processes and if you really think about it, what is it that we're trying to say? We're trying to give information to the public on a voluntary program where sponsors may choose, if they wish, to use a standard for which we will accept the declaration of conformity.

Scott Colburn:               So with the guidance now, is the fact that we can in advance of the federal register notice, describe our intent to recognize a standard by updating our recognition database prior to the publication of our federal register notice, thereby giving sponsors and staff the opportunity to utilize that standard towards a declaration of conformity before the federal register notice goes out.

Scott Colburn:               So that becomes real important, especially when we're trying to get standards up to address public health concerns, or major overarching issues like cyber-security, or certain new technologies that are coming about. And maybe just because of some administration things that are going on, federal register notices are being backlogged, we now can communicate to our recognition database in a much more nimble and much more efficient way. The use of those standards to support a declaration of conformity and we feel really positive that this will really help out all staff and sponsors.

Scott Colburn:               So the intent to recognize will be one big area. On the other side, what we have also learned through the comments that came in from our stakeholders is that, recognizing new standards and then withdrawing those older standards isn't always as easy to the manufacturers as it may seem. And while we're always trying to recognize the newest version of a standard as early as possible, we do recognize that that can have a big impact in how a sponsor's communicating use of standards in their submissions.

Scott Colburn:               Therefore what we are also instituting is transition periods for standards that are going to be withdrawn by a newer version of a standard to which it will be replacing. So what you'll start seeing now is instead of just a complete withdrawal of a standard immediately upon recognition of a newer standard, there will be a transition period that will be outlined in that outgoing standard for a period of time where both standards will be recognized. That way if someone's submitting a submission and it comes in on a Monday, but on Friday those standards were removed, that submission isn't left with a bunch of declarations of conformity to standards that are no longer recognized.

Scott Colburn:               There will be a period of time where both of those standards will be together, the appropriate use of them will be explained so that way a manufacturer will understand how their declaration of conformity will still be able to be used, even if it's a standard that's going towards a withdrawal.

Scott Colburn:               So depending on the type of standard, we're looking at giving different lengths of transition periods. In the area of 60601 sponsors that have been using those standards, it's familiar with this type of information because of the impact that, especially the most recent amendment has had on the manufacturers use of the risk management files and how that impacts the overall quality system.

Scott Colburn:               What we really wanted to find is where else does this impact, when we do these types of withdrawals? We found that we need to be consistent across the board. And with that you see where we are going towards on that.

Scott Colburn:               The last update I really wanted to talk about is how we are describing and really trying to imprint the culture of, "What is the declaration of conformity versus a general use of the standard?" Section 514-C of the act which our program is based upon states that FDA will recognize standards to which we'll accept the declaration of conformity to.

Scott Colburn:               I want to make sure that that's very clear in that it's not one of those, "We recognize standards that then we decide which ones we will accept the declaration of conformity to." The declaration of conformity's acceptable to standards that are recognized.

Scott Colburn:               The culture on both sides, both with sponsors and how they indicate the use of standards as well as sometimes how regulatory authorities accept the declaration of conformity doesn't always seem to have followed the tense of the law. The guidance resets that to ensure if you are utilizing a standard that is recognized by the agency, and using it in accordance with that recognition, we'll accept declarations of conformity to that standard.

Scott Colburn:               What we've also added is that when we speak about, "What is a declaration of conformity?" We're speaking it into the terms of how it is actually defined in the IEC standard 17050-1 and the supplemental information that is provided in the 17050-2 of that standard. And we feel that this will allow us to get a lot more in line how other regulatory authorities use the declaration of conformity by outlining the general requirements of, what are those elements? As well as the supporting documentation to support such declarations.

Scott Colburn:               Because we know most standards do not lend themselves to, "I declare conformance of standard, full stop." Signed by responsible individual, there's a lot of information that needs to be supporting the documentation of that declaration because of maybe different options that are employed or the end points of the test methods are not complicit in the standard, and we have a number of other potential issues.

Scott Colburn:               The guided tier helps outline, what is the level of information that we would expect to see from the manufacturer to adequately support the declaration of conformity to a standard into submission.

Scott Colburn:               So I think I'll hold there for updates, there are a few other things like that but these are the main impact ones that I think are most important to us.

Jon Speer:                     Well I appreciate you sharing those insights, and folks I just wanna remind you that we're talking with Scott Colburn with FDA CDRH. Scott's very involved with standards and conformity assessment program at FDA and also talking with Leo Eisner, Leo is with the Eisner Safety Consultants and you can refer to him as, "The 60601 guy."

Jon Speer:                     Very insightful, and I always like to bring this back to, "Well, why does this matter?" And a lot of our listeners, I know, are very active in bringing new products to market and some people, I assume that they don't have an appreciation for the value that standards can play in their product development efforts.

Jon Speer:                     Leo and Scott you both have provided some insights to that, maybe in that vein, Leo I'll start with you a little bit on this. Obviously you're very involved in 60601, why should I be paying attention to what's going on with the changes to the standard as a medical device company? Why does this matter so much? I know that these things change every so often but so what? Who cares, right?

Leo Eisner:                    Well, you probably would care as a design manufacturer or design developer, because as things change that's gonna affect your requirements, your product specifications, your requirements inputs, the whole design development process. So there's a bunch of changes going on in amendment two, and some are significant, including updating some of the normative references. Normative references are the standards that we refer to in 60601-1 for example.

Leo Eisner:                    So 14971 the risk management standard for all medical devices, not just electrical, is being updated currently to third edition. It looks like, currently, it's gonna get published around December 2019, it's a rough date. That's getting referenced in amendment two, in the shortlist project.

Leo Eisner:                    Same with 62304 is going through a significant change to second edition for them, and it's cold software now, instead of just software, or medical software  I think. There were major issues with this last CDV vote, so I heard, literally in the last few days, we're talking about possibly a third committee draft. Which is unusual, going anything past a second committee draft, if even doing a second committee draft.

Leo Eisner:                    So I suspect the September 2019 publication date that they show on the website currently will shift. And depending how the shortlist project falls out, which now I heard yesterday, is shifting by another seven or eight months, we're talking June through August or 2020 now, getting published. We might be able to still sneak in the 62304 second edition, but it depends on the timing there.

Leo Eisner:                    Then there's usability, IEC 62366-1 will be updated as well, but for 601-1 it's just in the definition section, it's the usability of medical electrical equipment standard that's gonna reference it a lot more, which is the 60601-1-6, I know it's a mouthful.

Jon Speer:                     Yeah, well I mean that's helpful and I think you gotta keep your finger on the pulse enough to know where these things are moving. But obviously some of those things that you mentioned, we're talking a year or longer before we would expect to see these updates.

Jon Speer:                     Do you have any tips or advice for a medical device company who, maybe they're in the midst of product development right now, and they don't anticipate doing a submission for let's say 12 or 18 months from now, how important are these changes to these standards going to be to the thing that they're working on right now?

Leo Eisner:                    It really depends on the country that you're dealing with, how the standards apply. Because in the US and Canada, once you submit, as long as you don't change your product in the future, which you will over time of course. You don't have to update to the most current version of standard for that country, like Scott said. FDA has to recognize consensus database.

Leo Eisner:                    Health Canada has a list of standards, harmonized standards that are listed, which for 601 is so far behind state of the art it's ridiculous. And that's a political issue that I'm not gonna get into, it's not worth it today.

Jon Speer:                     But that's a really good point, you talk about state of the art, by the time a standard becomes published, it's got some age to it.

Leo Eisner:                    Yes, no question about that.

Jon Speer:                     But I think that's important for companies to understand who are listening to this is, a standard, at least in my very simplistic way of applying what it means is, it's an accepted practice, it's an accepted way of doing things so to speak.

Jon Speer:                     Scott, you mentioned it a couple times a moment ago about the declaration of conformity and having quite a bit of experience putting together 510(K)s pre-submissions, things of that nature. In my past, I know how important that declaration of conformity can be, so can you maybe speak to that just a little bit?

Scott Colburn:               The declaration of conformity by definition, is that. It's a legal statement, it's a responsible statement and it's showing that not only did you just take the standard and apply it to how you feel it fits, but you're also following the standard in accordance with its intents for how a declaration would be accepted.

Scott Colburn:               In the United States the declaration of conformity, especially the regulatory requirement in the regulatory environment is a legal statement. It is a legal statement that is responsible by the organization who is making it, indicating that it is truthfully being done in accordance with how the outline of that standard is done.

Scott Colburn:               That way it becomes a confidence relationship builder in terms of understanding how testing was conducted, was it done in accordance with how the scope of that document was put there. And how does that fit in then to the whole world picture?

Scott Colburn:               One thing I always do say is, "Well the declaration of conformity is paramount to how standards are used and their importance, in an of itself is not a clearance or an approval to a product, but it does really start defining how the pieces of that puzzle are being filled in through the use of standards."

Scott Colburn:               In certain product areas, especially in the 60601 space, where we start having particulars to certain areas that do a really nice job of walking through all the essential performance and outlining the basic safety calls that device should be conducting.

Scott Colburn:               And doing the appropriate work of how the most recent amendment applies risk management, you can get really close to describing all the necessary features of what's needed to approve your submission by the appropriate use of those standards. Your declaration of conformity is your pathway to describe how you met that standard appropriately.

Jon Speer:                     Yeah and I may take it a step further, Scott and folks, if you have a device that you're developing, for example where it's an electrical medical device and you do not have a declaration of conformity to 60601 and the applicable parts and pieces that may apply to your product, it's gonna do more than raise an eyebrow when it gets to an FDA reviewer.

Jon Speer:                     Scott mentioned, this is important because it is an accepted series of activities, sometimes it even describes specific test methods that one should do to be able to demonstrate that a certain aspect has been addressed. If your device is electrical in nature and you have not done a declaration of conformity to 60601, it's gonna raise a flag.

Scott Colburn:               More importantly too, what we're looking at in the use of the series is appropriate use, if you have a collateral, that collateral standard or a particular standard, that particular standard will call out the relevant collaterals and how to use the base standard to establish your essential performance.

Scott Colburn:               What we want to see is, how are you appropriately applying that particular standard to try to really demonstrate how you have defined your basic safety and essential performance. That's a really important aspect because that's where the agency starts seeing variations in how a manufacturer, or even a customer that maybe their contracting with, applies that process and so if we get people to appropriately use the right standards in defining their criteria.

Scott Colburn:               It allows us to have that better understanding versus if they're just using the -1 standard and kind of not really mapping their product how it was addressed, then the use of that standard we get a lot of variability. Of course with that you start seeing questions coming back, which only slows the process, and we want to try to not do that.

PART 2 OF 3 ENDS [00:32:04]

Scott Colburn:               Coming back, which only slowed the process, and we want to try to not to do that when we're using standard. The whole idea of recognizing standard is to lower burden on both parties as much as possible, to get to the areas that standard's don't adjust.

Jon Speer:                     Yeah, it's a really good point. And Scott, you mentioned something a moment ago about the FDA "Consensus Standards Database," and folks, this "Consensus Standards Database," has come a long way in recent years. So Scott, whatever role you played in that, thank you efforts should certainly be applauded on that. But Scott, you made a really interesting point earlier. Because, Leo, you could tell us all about how expensive, you know, if you were to go out and purchase standards. I wouldn't advise that, because it can get very expensive, very quickly. But I would advise going to the "Consensus Standards Database," as kind of that first stop to evaluate, Okay, what are the recognized standards in that one two-page summary that Scott referred to is really great source for you to identify possible standards that may apply to the things that you're doing. So Leo, Scott, do you have any other tips, or advice for people to try to determine which standards apply, and how to go about assessing and evaluate those, rather than just buying them?

Leo Eisner:                    Sure, the first thing I do a lot of time is called "Scan the IEC," and also the ISO sites. Putting in terms that are common to the product, like [inaudible 00:33:38], or "infusion sun," products are fully infusion pumps, but I've seen clients use parts of the standard. The other thing, is there's a guidance database in FDA, which is extensive. The search terms are a little more rigid sometimes. From what I have seen from personal-use that you might have to try multiple shots at it, and also, going into the "Standards," database on the FDA web site, and putting in terms that are common to your product, that are particular to your product. Because there's a lot of products out there that use multiple, particular standards, like ETG, and SPO2, etc., that you need to go searching through the sites, the regulators that you want to work with, any "standards," databases that are out there, IEC, and ISO. You can steep the scope of the standard, and the scope of the standard will give you pretty good idea if it could apply or not.

Leo Eisner:                    The only drawback that I hate about IEC, and ISO, well not only I should say, one of them, is that they stop the scope, so unless you really know what scope is, it's hard to evaluate whether that standard is going to fully apply, or partly apply to my device sometimes. Which is a struggle. So at that point, you may want to try to contact either Test Lab, or a consultant, or some other standard's development expert out there.

Jon Speer:                     Yeah, and I was just made aware of this program that's FDA recently, and I'll be honest, I didn't know it existed.  But Scott, I'm putting you on the spot here, but are you familiar with the "DICE," organization within FDA?

Scott Colburn:               Yes, yeah that's our consumer assistance group, and they're there to try to help answer, and if they can't answer, field questions that come in from any stakeholder, really.

Jon Speer:                     Yeah.

Scott Colburn:               And a lot of them end up coming towards the Standards, you know?

Jon Speer:                     Yeah.

Scott Colburn:               They're kind of a catch-all for a lot of different questions. But yeah, it's a very helpful resource that would be of good use, and a lot of times too, there's ways to contact different parts of the pre-market office, to see if you need to come in, and ask for some formal questions where you can get the "Official Response," back as well. And that's the Pre-Submission process that is available, so if you're planning to do a 510(k), which you're not quite sure of how certain things might apply, you may want to think earlier on in your development process. And know that having a formal Pre-Submission come in, that you saw that they call it, and helps open up doors of communication, and show that you're a responsible organization as well. That really cares about trying to communicate what you've done, and to kind of know as well what other things that you might need to do that aren't apparent in the "Standards," area, or maybe, it's listed in the "Guidance," that might be a little bit older, and/or your product has newer technology, and you just need to figure out, "How can I apply these tools to get the right-level of information to support a positive regulatory decision?"

Jon Speer:                     Yeah, those are really good tips. So Scott, I know we're doing a webinar with you, and with Leo, later this year on the "ASCA," program.  And I'm told ASCA is kind of a buzz-word from FDA lately. Can you explain a little bit about what ASCA is, and what is significant with this new pilot program?

Scott Colburn:               Yes, I'd be happy to. We're really excited about this new program that we have, abbreviated under "ASCA," A-S-C-A. It stands for the "Accreditation Scheme for Conformation Assessment." Overall designs have improved the pre-market process by increasing confidence in, and reliance upon the decorations of conformity, to certain FDA recommended standards, in a voluntary pilot program. I will say again it is a pilot program. It's designed to figure out how to help the agency improve it's confidence, and understanding, and initiate new areas of communication with stakeholders that we don't regulate. And what I'm speaking to are the testing laboratory community, and what we're seeking about accreditation, in an accredited lab, the accreditation body in that community. We really only experienced relationships, and how the products are tested to stand, by going directly to the manufacturer. And with most manufacturers, as we know being small manufacturers less than fifty people. A lot of times testing was conducted in a third-party environment, and in many of those cases, those are in an accredited organization. And we really have no appreciation or understanding of how that has impacted. And sometimes we don't even see how that's translated in a pre-market review submission.

Scott Colburn:               So if the idea of this program is to tap the lives of prominent, and increasingly prominent role that standards play ... like science and practice, and work with accreditation bodies to help understand how are they determining what testing labs are competent underneath their scope of accreditation, to the standards that we are trying to focus on? And try to see what we can do by building a relationship, providing information, and even education to those laboratories, so that way they go under contract with the manufacturer, and are doing testing to certain standards. They have that perspective of what the regulatory agency is looking for, and how things are tested. Because as we know with 606, the one world, that's not a standard that's written as a recipe in a cook book. It has a lot of options out there to which to consider. And when you have to do that, we want to make sure that the labs are clearly able to provide a test report that reflects how a manufacturers define their essential performance. For example, or why certain test methods were chosen over others, and how does that fit into the bigger picture, so manufacturer can take that information, make an appropriate declaration of conformity, and the agency having confidence in that approach of how the testing is done.

Scott Colburn:               What we're hoping for is the need for consultations internally, and the regulatory side. You know, the request to complete-test or report reviews, and in addition to information of diminish, as our confidence in testing labs and abilities grows, and how manufacturers are purport to legalizing those laboratories towards certain standards. And those FDA manufacturers will benefit from the uniformed decorations of conformity, with that ultimate goal of what we already speak to, is that one test, test once, means everywhere.

Jon Speer:                     Yeah that's an exciting program, and folks I encourage you to pay attention to what we're doing at Greenlight Guru, because as I mentioned we are going to be doing a webinar later this year, on the "ASCA Program," with both Leo and Scott. And I guess, gentlemen, before we rap up today's session, any last minute tips or pointers that you'd like to offer our audience in the meantime?

Leo Eisner:                    One I would bring up, which Scott and I have talked about many times. Especially around the "ASCA Program," is that FDA has gotten more focused on the essential performance of the 601 series of standards, including the basic or general standard, 60601-1. And Scott mentioned briefly that they're looking at test lab has looked at an analysis that a manufacturer has done, and why there is or isn't essential performance. If there isn't there better be really good justification, and that analysis will be looked at by the FDA, almost guaranteed. Because I've had several projects, in last two-or-three years I think, that have come about just because of the essential performance questions from the FDA. So it's one really big concept to be aware of I think.

Jon Speer:                     Alright great. Scott, any last-minute tips or pointers for our listeners?

Scott Colburn:               I think to add on to what Leo said, is to just listen to what the whole theme of what everyone's been talking about. The whole purpose of what we're trying to do is improve the relationship of how the agency understands, and sees the appropriate-use of how risk management is applied into the variety of different settings. And we know that 60601, has a huge foundation for the use of ISO-14, and 7-1, and risk management. But this goes across almost all standards, and really at the crutch of how regulatory science, or assessing substantial equivalents and safety infractions is based upon the assessment of risk. And what we're really trying to do is improve the internal, and external understanding of appropriately applying that both the standard, as well as to just the overall process. It kind of then allows us to use all of the different resources, rather than whether it's using guidance documents, or other standards that may or may not be cited, but then apparent standard.

Scott Colburn:               And so this is really a part of that genesis. The idea of ASCA, get this in bulk, in the areas of testing, and the testing environment. We've been very much involved over several decades with the development of standards, and we have a great history of recognizing standards. We want to bring that up to the next level, by doing the same thing with the relationship, and the testing community. So that we can help provide any perspective, but just as much in all of the importances, understanding the rigors of what does the accreditation process entail? What does that mean towards quality of testing, and how data then can be used to help expedite regulatory decisions. 

Jon Speer:                     Terrific comments Scott, and folks, I want to thank Scott Colburn. Scott is the Director of Standards and Conformity Assessment Program, at FDA CDRH, And as you have probably picked-up from Scott giving a glimpse of the ASCA pilot program, and if you've been paying attention to a lot of the other pilot programs that are in progress at the agency right now. This is a new FDA. This isn't the FDA from ten, or even five years ago. It's a much more collaborative, a much more progressive organization, and it's really out there to try to bring new technologies to the market to help improve patient's lives. Which is very much in alignment with what many of you are trying to do with the products that you're designing and developing. So FDA is very much a collaborative partner with industry these days, so pay attention to these pilot programs. Because they are out there to try to make life a little bit easier for all of us, and ultimately help improve patient's lives.  I also want to thank Leo Eisner, folks he is the "IEC 60601 Guy." If you have any questions about timing, and the nuances, and the specifics of 60601, and all of the collateral standards that are impacted by that series, I would encourage you to reach out to Leo as well. You can find him very easily, go to Eisnersafety.com, and learn more about what he's doing. But gentlemen, thank you so much for being guests on the Global Medical Device Podcast, today.

Leo:                              Thanks Jon.

Scott Colburn:               Thank you Jon. It's been our pleasure.


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