When to Throw the Least Burdensome Flag on FDA

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? 

Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.

In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.

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Some highlights of this episode include:

• You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.
• Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.
• Despite some trite responses, the FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.
• Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.
• Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.
• The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.
• Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.
• The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.

Links:

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

FDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles

510(k) Submission Process

Investigational Device Exemption (IDE)

ISO 10993 - Biological Evaluation of Medical Devices

Code of Federal Regulations (CFR)

Medical Device User Fee Amendments (MDUFA)

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from Mike Drues: 

“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”

“We should respect the FDA, but at the same time, they should respect us.”

“The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”

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: What if you submit your 510( k) or your IDE or other type of submission to FDA and you get a response and you think the information that's being requested is overly burdensome? What do you do? Is there a process? Do you just accept it and move on? Well, these are great questions. Well, the good news is there is a process. There is a methodology that you can deploy if and when these scenarios come up. And of course who other than to talk about this is Mike Drues with Vascular Sciences. We dive into the at least burdensome approach and this pilot program that FDA has, and yes, you might even be able to throw a flag on the play. But we talk about all the ways to escalate and to deal with and to manage if and when these scenarios come up on this episode of the Global Medical Device podcast. Hello and welcome to the Global Medical Device podcast. This is your host and founder at Greenlight Guru Jon Speer. And joining me today is Mike Drues with Vascular Sciences, the regulatory guru that I'm sure many of you are familiar with if you've listened to the Global Medical Device podcast in the past. Mike, welcome.

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

Jon Speer: Absolutely. You brought something to my attention recently that I had to confess before we hit record and dove in that this was news to me, even though it's not technically speaking super new and the topic is, I guess, FDA or CDRH has a pilot program. I'll use air quotes around that. We can talk a little bit more about that in a moment, about least burdensome flag I think is what the pilot program or something to that extent is called. But I guess maybe that's a great place to start. What is this all about, this least burdensome issue or this pilot program that is available through FDA, CDRH?

Mike Drues: Yeah. Great question, Jon. And just to put sort of a scenario around this to help our audience understand why this is important and when they might use it. Imagine if you do a pre-sub meeting with the FDA or even worse, you make a submission to the FDA and FDA asks you to do certain things, maybe biocompatibility testing, maybe usability testing, what have you, that you think are overly burdensome. The question is, what option do you have if any, to push back? If they're asking you to do something that you think from an engineering or a biological perspective is not necessary, if you think they're asking you to do something that maybe your competitors have not had to do, what kind of options do you have? And so that's sort of the context around. To set the stage, first and foremost, I would say to you and to our audience, that if that's going to be the situation, we really want to find out about that sooner rather than later. In other words, it happens all too frequently as you know, Jon, and we've talked about many times that company makes a submission, a 510( k) submission to the FDA for example, only to come find that FDA wants more data, more testing, more whatever it is. And I don't want to go too late but really that should have been found out long ago. Ideally, as you know Jon, I'm a big fan of the pre-submission meeting, the pre-sub, that's when we should find out. When we find that out, the first thing that we want to try to do is try to understand why. Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they're looking for this information. In other words, Jon, if FDA tells us," Well, we know of a problem that's happening with another similar device and we want to make sure that that problem doesn't happen here." Okay, that's fair game. That's FDA's doing their job. That's what they're paid to do. But if they give you some trite response and believe me, Jon, I've actually heard this before," We're essentially FDA. We can ask you to do whatever we want." I'm sorry, Jon, but that doesn't cut it. Find out from them what specific reason that they have. And then the last piece of advice is ultimately you have to decide if this is worth fighting over. As my wife likes to say," You have to pick your battles." Some things are worth fighting over and some thing are not. At a high level, Jon, that's kind of the context of the discussion. And as we'll get into in a moment, this option that companies have to throw the least burdensome flag as FDA likes to call it but I just want to make sure that you and our audience understands the scenario leading into this discussion first.

Jon Speer: Yeah, it makes sense. And as you were describing that, I was reminded about a project that I worked on. It's probably been at least 10 years ago and it could have even been longer ago but the scenario went like this, I don't think pre-submission was a vehicle or an option then or at least it wasn't in vogue or as popular or as well understood maybe as it is today. But nonetheless, we felt like we had a, I will say pretty clear and cut and dry submission. And we knew this going into this but it was for a wound care type product. And one of the components of the wound care was a polyurethane foam material, I think. At least at that time, there were literally two raw material manufacturers of this particular foam in the world. Every wound care product that had this kind of foam was getting it from either supplier A or supplier B. And we worked very closely with one of the suppliers and they had indicated to us that they had done a litany of all the applicable and appropriate biocompatibility tests. They provided enough evidence to us, summaries and things of that nature to corroborate that. And they had indicated they had some sort of master file with FDA and actually authorized FDA to access that particular file on our behalf. That was the weight we were leaning on from a biocompatibility standpoint. It's already been done for the exact intended use to the latest, greatest versions of 10993 and so on and so forth. Here's the letter authorizing FDA to access that file on our behalf. We get into the submission and we got AI letter from FDA, from the reviewer. He was adamant that we needed to do the full battery of biocompatibility tests. And I don't have to tell you this but that was going to be eight to 12 weeks worth of time and cost.

Mike Drues: Ca-ching, ca-ching, ca-ching.

Jon Speer: Ca-ching, ca-ching. Costs at least 50 grand if memory serves, it might have been more than that but something that we didn't obviously plan for that delay. I felt like we were proactive enough to think about that before we went to the submission. And so we came back and explained our rationale and this person was adamant this reviewer was like," No, you must do that and because I'm FDA." I kind of had that experience.

Mike Drues: And these are purely hypothetical scenarios, Jon, of course these never happen in the real world. And as an aside, I always get nervous when I hear somebody refer to a, to use your phrase Jon, a cut and dry submission.

Jon Speer: Yeah, I know.

Mike Drues: Because in the 30 years that I've been playing this game, rarely do I run into a cut and dry submission or what I like to call a slam dunk 510(k). There have been a few of them but rarely is it as simple as that.

Jon Speer: Yeah. Again, the story I shared is hypothetical, maybe real story that I shared, at least happened 10 years ago. This lease burdensome flag, this is newer. It's been around for a couple of years. When did this go into effect?

Mike Drues: This particular guidance came out in draft form in 2019 but the concept has been around for a very long time. But maybe to lead up to that point Jon, because that is one option that a company has when they think that the FDA is being overly burdensome but it's not the only option and it's not the first option. Maybe we should take these in order of escalation. I break these options into two camps. First are what I call the informal options and then the formal options. Informally, the very first thing that you should do as the company is as best as you can, as I said a moment ago, understand the concerns of the agencies and then work with the review team, specifically the lead reviewer, to try to come up with a compromise, a meeting of the minds. You want to try to solve of this as best as you can. And by the way, Jon, this could be a topic of another discussion. There are a number of techniques that I have in my repertoire to do that. I'll just share one as a quick example. If I know that there's not consistency across the review team, in other words, if I know that certain reviewers are okay with what I'm proposing and other reviewers are not, I will literally pit one FDA reviewer against another. Kind of like a child will pit mom against dad. And I've done this very successfully. In other words, even though as I work as a consultant for the FDA, when I'm working for a company, I'm sort of an external guy, why not have somebody within FDA fight my battles for me? And I've done that a number of times, you have to be a little careful how you do that obviously, otherwise it could blow up in your face but that can be done. The first step is to work with the reviewers and the lead reviewer to see if you can come up with a compromise as the lawyers like to say, a meeting of the minds. The next, the category of informal is you might have to use your word from earlier Jon, escalate it. You might have to kick it up a notch. In other words, you might have to get the division director or perhaps even the branch chief involved. And by the way, I never, ever, ever do this in writing, Jon. In other words, what I will do is I will contact that person via email but my email is going to be very, very short and basically just ask them," Hey, can we set up a 10 minute meeting, a phone call?" And the reason why I like 10 minutes is because it's usually short enough that you can do it under the radar. In other words, without getting a lot of people involved in scheduling and all this other nonsense that just keeps things from moving along. And I don't say anything in the email about what I want to talk about on purpose because what I want to do is I want to have a discussion. I want to be able to voice my concerns and see if we can come to a meeting of the minds. And if we can, then we put that down in some form of documentation. In other words, it's kind of like, what's the expression, Jon, about sausage making? You never want to watch as the sausage is being made.

Jon Speer: If you watch it, you would never eat it.

Mike Drues: Correct. I don't want to document how the sausage is being made. What I want to do is I want to document the final product, the final sausage, once we all agree of what that sausage is going to look like and what it's going to taste like and so on. And to some in our audience, Jon, the regulatory folks and the quality folks, that's probably considered heresy, oh my God, have conversations and not document. But I'm purposely being very pragmatic here. Under the category of informal advice, those are the first couple steps that I would offer.

Jon Speer: Yeah. Can I chime in and ask?

Mike Drues: Please.

Jon Speer: The reaching out to the branch chief is interesting. I think I heard you say you do request that meeting via email. You don't pick up the phone and try to connect with that person.

Mike Drues: Well, you could do that too. I'm old fashioned. There is something to be said. One thing that a lot of people seem to forget nowadays is that the Earth was able to get around the Sun for a very long time, without email, without texting, with all these. There is something be said for just pick up the darn phone and say," Hello."

Jon Speer: Do you think you have, because when you're doing this, you're contacting them as Mike Drues, Vascular Sciences, not as a representative or an identified representative, if you will, of company ABC or whomever you're calling on behalf of. Do you think that gives you an advantage?

Mike Drues: Yeah, that's an interesting question, Jon. In most cases I am calling on behalf of the company.

Jon Speer: Okay. They know you calling for this guy.

Mike Drues: Correct. Correct. Now, in some cases I will make a blind inquiry but I don't know that that's part of our different sort of a scenario. Let's just assume that I'm a representative of the company, just like a regular employee.

Jon Speer: Okay. You have this conversation, this informal undocumented conversation, you have this meeting of the minds and those scenarios where there's agreement and alignment, do you then follow up with documentation at that point?

Mike Drues: Yeah.

Jon Speer: Okay, cool.

Mike Drues: Yeah, absolutely. Once we do get the meeting of the minds, the agreement, then we just agreed. And so there's full transparency. I'm not trying to hide anything or cover up anything. We do all that we can informally to see if we can make this work. If we can't be successful in spite of our best attempts to work this out amicably, then it might be necessary to start to get a little more formal. And that brings us to the next option, which is literally what FDA calls the least burdensome flag. And this is something that's mentioned in all additional information request letters or at least it should be. Although interestingly enough, as I was thinking about our conversation today, I did remember one situation fairly recently where we got an AIR, an additional information request and that least burdensome flag was not in there. And I pinged the lead reviewer. I said," Copy, but I don't see it in there." He said," Yeah, you're right. I forgot to include it." And I sort of made a joke about it. I said," Well, and this is good that this company has a good regulatory consultant that knew this option and told them about it because if they didn't they wouldn't have known about the option."

Jon Speer: Yeah. Because I think a lot of times when companies get these AI requests, I think you mentioned this earlier, it might have been before we hit record but I think a lot of people would just like, well, we got to do it because they say. There's no question. Even if you don't understand it, it's sometimes just go along blindly, follow through with the things that are being requested for.

Mike Drues: Well, this is on a personal note, Jon, this is a huge frustration of mine with so many in this industry. Not in, just in the medical devices but I see the same thing in the drugs as well. They will unconditionally do anything and everything that FDA will ask them to do. And I just have a huge problem with that. Like I said at the beginning of our discussion, Jon, if FDA has a legitimate concern, then fair enough, they have the obligation to tell us what their concern is but FDA cannot just say," Well, we want you to do this because we're the FDA." We should respect the FDA but at the same time they should respect us. That's a two way street. And I don't think there's anything unreasonable when we ask the question," Hey, why are you asking me to do whatever it is that you're asking me to do?"

Jon Speer: Totally. Have the conversation, understand why the request is being made. Digest it, discuss it amongst yourselves, so to speak, to determine, okay, does that make sense? Does it not make sense? And in the event that it doesn't make sense for whatever the reasons are, then you throw this flag and say, and how does that happen? Is this a phone call, an email? Is there a form? How does that work?

Mike Drues: Great question. In anticipation of our discussion, I actually printed out.

Jon Speer: Oh nice.

Mike Drues: The least burdensome section of which is supposed to be in all of these AIRs but as I said, at least in my experience, I gave you that example of one that was conveniently omitted, conveniently omitted. I just thought I would highlight a couple of these and this is totally boilerplate, Jon. There was absolutely nothing unique here. And as a matter of fact, since I did voice a few of my other personal frustrations earlier, let me add one more to that list. So much of what FDA gives us in terms of written feedback is boilerplate. And I don't know about you, Jon, but when FDA says to me in a written response," Oh, consult this guidance and do what it says in this guidance." Is it just me or is that patronizing if not condescending? It's like gee, why don't I see if there's a guidance out there? I would've never thought of that. Anyway, I'm not trying to be cynical but I'm being very serious here. I respect the FDA but I want them to respect me as well. This is a two way street. Specifically with regard to your question on the least burdensome flag. What it says in this boilerplate explanation and some of it is pretty good. The goal of the least burdensome flag is to quickly address FDA requests. And please keep in mind that that's government using the word quickly. Their connotation of quick might be a little different than your connotation of quick. Quickly address FDA's request that submitters do not believe are least burdensome or when submitters believe that they are being held to a different standard than the legally marketed predicate devices. This is, as I said earlier, if you think that FDA is being overly burdensome in asking you what to do, based on the biology and the engineering, if you think they're asking you to do something that your competitors have not done, then this is when you can throw this least burdensome flag, which metaphorically speaking, Jon, this is exactly like football when the referee throws the flag on the field. They further go on to say that there are several criteria that you should meet before you submit your request. Before you throw this flag. First of all, you should have tried to address your concerns with the lead reviewer, as well as division management before throwing the least burdensome flag.

Jon Speer: All the informal mechanisms that you mentioned.

Mike Drues: Exactly. Gee, there's a thought, before making a complaint to your company, talk to your boss first. There's an idea I would've never thought of. The second thing that they say here is that your flag should be generally limited to topic area. For example, biocompatibility, sterility, reprocessing, usability, whatever it is limited to. Okay, fine. If you have, let's put it this way, Jon, in FDA's defense, if you think FDA is being more burdensome in more than two areas, you've probably got bigger problems going on here. And anyway, we'll leave it at that. And then the last sort of minor thing they say here is if you're going to throw this flag, you need to do it within 60 calendar days of FDA issuing you your AIR or your deficiency letter. I think that's reasonable. It's statue of limitations. Because they don't want these things to linger around for many, many months or years or whatever. Those are the criteria according to FDA's own least burdensome flag description that FDA would impose. That's basically the mechanics. Does that make sense, Jon?

Jon Speer: It does. Yeah.

Mike Drues: All right. Let's take it one step further. Let's say you do everything that you can working with the reviewers. You can't come to a meeting of the minds. You talk to a little bit of the management yourself. In spite of your best attempts, you still can't come to a meeting of the minds. You throw the least burdensome flag and you still can't come to a meeting of the minds. The question is, what option, if any, do you have now? Well, now you're really into the big leagues. The best option here, maybe best is not the right word, the most powerful option, it's what I call the nuclear option. Because it's my option of last resort is you can take your case to the ombudsman's office. Now this is totally independent of CDRH. In other words, the ombudsman is not part of of CDRH. They report directly to the office of the commissioner. If you remember the old TV show, Jon, the People's Court, it's kind of like the Judge Wapner. And I'm really dating myself here.

Jon Speer: I remember that show. My dad used to watch that all the time.

Mike Drues: Or Judge Judy or whoever the heck is doing it now. I don't know. But basically what you do is you present your case to the ombudsman, the reviewers present their case to the ombudsman. And at the end of this process, the ombudsman will decide, okay they think that the reviewers are correct or the company is correct. Now in the 30 years that I've been playing this game, Jon, I've only had to do this a handful of times. It's my nuclear option or option of last resort. Can you think of why, Jon, it's always an option that I share with all of my customers, but why do I say to them, it's an option of last resort?

Jon Speer: This is data that influences your company's relationship and maybe your own personal relationship with FDA and CDRH. There's a good chance that you're going to engage or interact with them in some way, shape or form at some point in time down the road, whether it's in a new product submission or maybe during an FDA inspection. And if you're perceived as a hostile witness, so to speak, you may get a different sort of behavior. Hopefully not but that would be my suspicion as to why you want to tread cautiously with this.

Mike Drues: You're exactly correct, Jon. To simplify I think what you just said, remember the adage, you can win the battle but ultimately lose the war. And that's exactly why I call it my option of last resort or the nuclear option. The reason is it is possible and this has happened to me now a couple of times, where the ombudsman sides with me and says that the reviewers overly burdensome. Well, sooner or later, as you just suggested, Jon, I'm going to be dealing with those reviewers again, either on the same device or perhaps a future device. When I walk into the room, are they going to be thinking, oh, there's that whackadoodle Drues guy. Last time I'm going to make his life a living you know what today. Now, I will would like to think that those things don't happen in the real world, Jon, but I also did not fall off the turnip truck yesterday. I know that those things do happen. The ombudsman is a path. It's a legitimate path but it is in my opinion, the path of last resort.

Jon Speer: Okay. That challenge or escalation to that point in the process, that challenge is, I think we described that pretty well. Are there downsides or challenges to escalating matters that you can think of?

Mike Drues: Yeah. Great question, Jon. The short answer is yes and no. It really is both. As I said before, you need to pick your battles. Some things are worth battling over, some things are not. My advice there is very simple. If it's not necessary to fight, then don't fight and save your political capital for a future battle. But if it's something worth fighting over, then by all means, put up some resistance. Obviously you want to be respectful of the agency. They've got a very important job and I will never diminish the importance of their job but on the other hand, I have a healthy respect for the FDA, Jon, but I do not worship them. I do not put them on a pedestal. I do not assume that they are my teacher, my professor, that they somehow know more than I do. As a matter of fact, if they know something more than I do, Jon, then that's indicative of a whole other set of problems. I should know just as much as FDA if not more about my product than they do. And don't worry, sometimes people ask me," Well, we don't want to ruffle anybody's feathers." Well, that's not a concern to me. If there's a legitimate reason why you should ruffle somebody's feathers then by all means, if you're not making waves, you're not paddling. If you get kicked in the rear you know you're out in the front. I guess my message there, Jon, is very simple, have a respect for FDA. As I've said before, physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time. There's nobody that has a higher respect for the agency than I do. But there's nobody that will push back on them harder when it's necessary, when I do think they're being overly burdensome. And a number of times I've been in that situation. Am I successful a 100% of the time? No, but I can tell you that I'm far more successful than I'm not.

Jon Speer: Yeah, yeah. Embracing some of the informal mechanisms that you described. Those make great sense because just having a conversation with the reviewer first and foremost, having the pre-submission interaction is probably mitigates a lot of these challenges and issues. I've got to imagine more than anything else but in the event that you do get the AI request and you feel it's a little burdensome, getting that clarification from the reviewer, maybe they didn't understand your perspective or what have you. And I've had that moment happen too, where the reviewer's like," Oh, I understand."

Mike Drues: That's happened. Let me give you another example, Jon. I guess as I'm getting older, I'm sort of disclosing more and more of the ingredients that go into my secret sauce that do achieve the results that I am proud to say that I achieve in our industry. You've heard me say many times, Jon, that I characterize the entire relationship between the company and the FDA as a poker game in every sense of the word. And let me give you a quick example of that. If FDA is asking me to do something and I do not think that it's justified, do not think that it's necessary, I can give you a number of examples in many areas, including as you talked about earlier, biocompatibility. Then one of the techniques that I will often use is I will say to the reviewer," Okay, Mr. Or Mrs. FDA Reviewer, I'm happy to discuss whatever additional testing you're asking me to do," and I want Jon you and the audience to pay particularly close attention to on how I'm parsing my words here because I'm parsing them carefully. I'm not saying that I'll do what you're asking me to do. I'm saying happy to talk about doing what you're asking me to do. But before we do, can you please point out to me where in the regulation it says that I need to do what you're asking me to do. In the poker metaphor, Jon, this is the equivalent of calling their bluff. Because if FDA says," Well in TFR blah, blah, blah." In other words, if there's a regulation that I don't know about, then shame on me and I'm not doing my job and quite frankly, that's professional incompetence. Fortunately for me, that doesn't happen very often. What is much more common is the reviewer will say," Oh gee, I don't remember. Let me look it up and get back to you." Well, more often than not Jon, that phone call never rings. That email never arrives. What I'm doing is I'm calling their bluff. Again, I want to be really, really clear with you and our audience. I'm not advocating taking shortcuts. I'm not advocating or endorsing avoiding certain testing that I think as a professional biomedical engineer is necessary. That's absolutely not what I'm doing here. But what I am doing is I am saying whatever we do, that needs to be justified. There needs to be a reason for doing it. And in my opinion, Jon, the reason for doing something like testing is not because it's written down in some regulation somewhere, it needs to be justified based on the biology and engineering. Does that make sense?

Jon Speer: A 100%. And I want to reemphasize a point that you made that hopefully is so obvious that it should never be mentioned to begin with let alone mentioned twice. But my goodness, if you are a regulatory professional, you need to know every single nuance, twist, turn, regulation. I would even say it's probably even a really, really, really good career move to also be memorizing all guidance documents doesn't seem pragmatic but knowing where the guidances are and which ones are applicable. And do your due diligence before you even put pen to paper or finger to keypad to type anything that you're sending to FDA first and foremost.

Mike Drues: I couldn't agree with you more, Jon. And to me, that's a no-brainer. It's like, before a car you're supposed to know the rules of the rule and imagine getting a ticket for not stopping at a stop sign and you go to the judge and you say," I'm sorry, your honor but I didn't know that when I saw this great big red eight sided sign, I was supposed to stop." That to me is, maybe it might sound unkind to some people, but that's professional incompetence.

Jon Speer: Yeah, it is.

Mike Drues: And so that to me goes without saying. But what I think is more important to understand Jon, you mentioned memorizing the regulations. I wouldn't advocate that for anybody and I never even ask my, as a matter of fact, I tell my graduate students," Don't memorize. That's a total waste of time. I want you to understand what I like to call the regulatory logic. That's infinitely more important than what the words say." But anyway, that's topic of a different discussion.

Jon Speer: But I think there's lots of good nuggets here. First and foremost, the obvious, know the regulations are the logic and navigating. That's important. We've talked a lot about different, I guess, communication tactics and techniques and escalation. Aside from those things, are there other things that you think are important about least burdensome flag and this approach that hopefully you never have to take but realistically you might have to a time or two, is there something else here you think is important as we wrap things up today?

Mike Drues: Yeah. Great questions, Jon. Just to kind of put all of this together and to see the big picture, to see the forest through the trees, so to speak. If you think for whatever reasons that FDA is being overly burdensome, if they're asking you to do certain things, certain kind of testing, again I could give a litany of examples that you think from an engineering and or biology perspective is not necessary, that maybe competitors have not had to do. First and foremost, work with your lead reviewer, work with the review team, try come to an amicable solution, try to compromise, which seems to be in Washington DC, impossible to do anymore. And by the way, one of the best definitions of compromise that I've ever heard, Jon, is when both sides of the table go away a little bit unhappy. If both sides, the company and the FDA is a little bit unhappy, that's probably a good thing. That's probably means you have a good compromise. Next step would be to escalate it, still informally to the division director or the branch chief and see if you can work something out there. But if that doesn't work, consider throwing the least burdensome flag. And finally, if that doesn't work, consider going to the ombudsman. You do have options in these kind of scenarios. You do not have to just do whatever FDA asks you to do unconditionally. And by the way, Jon, FDA cannot tell you to do anything. And this is something that a lot of people do not understand. They cannot tell you to do anything. I'll let you in with a little secret, Jon, when FDA in their written feedback says," We suggest that you do this, or we recommend that you do that." That's code speak. That's political correct phrasing for FDA saying that we expect that you're going to do this unless you come back with this other one. FDA cannot tell you to do something. You always have the right, if you will to go to the FDA and say," No, that's not appropriate," or," No, that doesn't make sense." Or in some cases, maybe it's not possible and here's what we're proposing instead. Finally, Jon, last and certainly not least, definitely have a healthy respect for the FDA but make sure that they respect you as well. This is a two way street and I'll be honest with you, Jon. I have to be a little bit careful what I say here in a recorded podcast that's going out to a big audience. You and I are fortunate, we have a pretty big audience. I work on the FDA side of the table too from time to time as an FDA consultant. I sometimes will ask a company to do or maybe I'll ask the question, why did they not do something that I don't think is necessary as a professional biomedical engineer, just to kind of see how they respond. In other words, if they respond back to me," Okay, fine. No problem. We'll do it."

Jon Speer: That's that's a pro tip right there.

Mike Drues: I'm not going to respect them as much. Obviously there's no tick mark on any regulatory form that says for or 510( k) or De Novo or a PMA, you have to be respected but I think you understand the point I'm trying to make.

Jon Speer: Couple things that I'll leave the audience with, at least summarize that last point I think is great. The respect thing I think is important. And I think the thing that I'm hearing you communicate is me as med device company and you've said this couple times maybe today and certainly in previous conversations that we've had. I better know my product better than anybody else. And I better know what I did and why I did it and what I didn't do and why I didn't do it. And I should feel that submission, whatever it be, a pre-sub, a 510( k), et cetera, et cetera, I should be able to stand behind that as whole and complete to support my case for, in the 510( k) path demonstrating substantial equivalence. And if you challenge me and I cave in, that shows that I didn't really know. I should be able to come back to you and say," Well Mike, we did this because of this. And we didn't do this because of this." And then we can have the meaning of the minds. I think it's a great test that you're putting companies through because there's a good chance they're going to get that test with a reviewer at some point in time. Getting prepared for that scenario I think is good. The other thing that I think is important is of course you know your product and your device, hopefully of course, better than anyone else. Certainly anyone from FDA. Just because you get an AI letter, is not the end of the world. It's not put on your gloves, time to fight necessarily. At least in my experience and not always but sometimes there's just a misunderstanding or a lack of knowledge. They don't know my story as well as I do. This is why it's good to have these informal conversations and get a clear understanding and get on the same page. That's another point.

Mike Drues: I agree with you, Jon. And I think that's a good recap and I know we're trying to wrap this up but if I may offer just one last.

Jon Speer: Yeah, please do.

Mike Drues: Pragmatic observation. Because unlike a lot of my regulatory friends who seem to live in what I call theoretical world of regulatory affairs, I don't know what universe that's in but I live in the real world. You mentioned about getting questions from the agency, not necessarily a bad thing. That's true but think about this. And again, I have to be a little careful what I say here. I have had reviewers admit to me privately they would never say this publicly and I'm sure my FDA politician friends at the FDA are going to get upset when they hear this but it doesn't change the fact that it's true. They have told me that they will send a company a question for no other reason than to stop the MDUFA clock because they have too much stuff on their desk at the moment and they have to buy themselves some time. Now, when I say that to people in industry, they say," Oh my God, how can this happen?" blah, blah. I say, you know what? Before you start casting stone in a glass house, consider this, how many people in companies play exactly the same game? How can we be willing to not tolerate something in somebody else that we're willing to tolerate in ourselves? I'm just being very transparent here, Jon.

Jon Speer: It's poker. It's poker and FDA might be calling my bluff. There's nothing wrong with that.

Mike Drues: There you go. There you go. As a matter of fact, I have, as you know, a number of former graduate students, some of them now work at the FDA. I have to be a little careful, even the secrets that I disclose to my grad students when they're on the opposite side. Anyway.

Jon Speer: Mike, I've appreciate you sharing your insights on this. Well, I think interesting program but this is common sense? Question mark. We'll leave it at that. But nonetheless.

Mike Drues: You know what they say about common sense, Jon, it's not as common as we would like to think.

Jon Speer: Yeah, I know. It's like conventional wisdom, but anyway, we'll leave that there. Folks as always, for me, it's a pleasure to have an opportunity to catch up with Mike Drues with Vascular Sciences. In my opinion, I've worked with a lot of folks in this industry, a lot of regulatory professionals and none better than Mike Drues. He brings a fresh approach. It seems as you hear him say it and talk about it, it's like, oh, well that makes complete sense. But to Mike's point a moment ago, sometimes that's exactly the point. That is not how we've been conditioned or maybe even followed or grown up in this industry. Sometimes we follow blindly down paths because we have this perception or idea. But Mike's a great guy to have on your team. If you're looking for that regulatory strategy and guidance and tips and pointers, reach out to him, Mike Drues Vascular Sciences. And of course, we're here to help you as well at Greenlight Guru. Greenlight Guru has the only medical device success platform on the market today. It is designed specifically and exclusively for medical device companies, by actual medical device professionals. We've got workflows to help you with design and development, risk, document management, all your quality events, CAPAs, complaints and things of that nature. And it's all on a single platform. Check it out. Go to www.greenlight.guru, we'd love to have a conversation with you and see if we have products and solutions to help you out. As always, thank you for listening to the Global Medical Device podcast, the number one podcast in the medical device industry. And that's because of you, our loyal listeners. Thank you so much. We greatly appreciate that. And until next time, this is your host and founder at Greenlight Guru, Jon Speer.

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