change to version of title

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments.

Mike Drues of Vascular Sciences joins Jon Speer on the Global Medical Device Podcast this week to discuss the importance of this document and how it relates to 483 observances and warning letters for medical devices.

 

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Some of the highlights of the show include:

  • What prompted nonbinding feedback guidance, and is it necessary? CDRH’s increased number of site inspections resulted in more warning letters.
  • CDRH is more aggressive with annual inspections because some medical device companies and their employees do stupid things, instead of the right things.
  • Goal of guidance is to improve communications with medical device companies concerning corrective actions in response to inspectional observations.
  • There are differences between a 483 and warning letter. A 483 is an inspectional item with room for improvement; a warning letter indicates a serious violation.
  • Guidance Process: Inspection is performed, company receives a 483, analyzes the observation, generates a response, and FDA returns nonbinding feedback.
  • If company’s response is appropriately implemented, FDA states: Response appears to be adequate, partially adequate, or inadequate.
  • Nobody wants to receive a 483. It’s usually inevitable, but not the end of the world. Be proactive and respond appropriately to avoid escalation.
  • A company needs to respond to FDA in a timely manner, which is within 15 business days. FDA tries to return nonbinding feedback within 45 calendar days.

 

Links:

Nonbinding Feedback After Certain FDA Inspections of Device Establishments

FDA In Brief: FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations

CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

FDA Proposes More Formalized Form 483 Communications for Medical Devices

Mike Drues

Greenlight Guru

 

Quotes:

“CDRH is taking a much more aggressive approach to these inspections and issuing more warning letters.” Mike Drues

“There are some medical device companies and the people in them that have done, and continue to do, stupid things.” Mike Drues 

“The goal...is to improve communications with medical device companies concerning corrective actions in response to inspectional observations.” Mike Drues

“I’m kind of a fan of this guidance. It has the potential to promote more of an interactive or collaborative type of engagement.” Jon Speer


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: Alright, FDA has been very active recently on a number of different guidance documents and one of the recent guidances that came out in February of 2019, is this guidance called Nonbinding Feedback After Certain FDA Inspections of Device Establishments. It's kind of a mouthful and kind of important to understand what this means and how this relates to 483 observations and warning letters and things of that nature. And Mike Drues from Vascular Sciences, and I explore this topic on this episode of the Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast, this is your host, founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. And in recent weeks, there's been a couple of guidance documents that you may or may not have paid a lot of attention to, that came from FDA. One of them, we're gonna dive into a little bit today, and this has to do with non-binding feedback after FDA inspections, and to analyze the scope and why this guidance may or may not matter to you, is a good friend and familiar voice on the Global Medical Device Podcast, Mike Drues from Vascular Sciences. Mike, welcome.

Mike Drues: Thank you Jon, always a pleasure to share this stage with you.

Jon Speer: Alright, I know, you and I, when these new guidances come out, we're always reading them, trying to figure out, okay, what's this all about and why does it matter? And I think that the timing of this conversation with you is important specifically, for this non-binding feedback guidance that came out. But in your opinion, what led to this new guidance, and I guess, the part two of that question is, do you think we really need this?

Mike Drues: Well, it's a great place to start, Jon. Just to remind your audience, and we can post a link to the guidance on to web page. The title of the guidance is, Nonbinding Feedback After Certain FDA Inspections of Device Establishments. It came out just a few weeks ago. And quite frankly, the events leading up to this are very simple. As many in your audience probably know from first-hand experience, the FDA, specifically CDRH, has significantly increased the number of annual in-site inspections that they're doing, both here and the US, as well as internationally.

Mike Drues: Here are some statistics for you, Jon. And this was kind of a surprise to myself, as well. Over the last decade, over the last 10 years, the number of foreign inspections has increased nearly 250%. And over the same period of time, over the last 10 years, the number of US inspections has increased by about 50%.

Jon Speer: Wow.

Mike Drues: And so, one of the things leading up to this is, that there's more inspections. But the other thing is that... And again, I suspect some in the audience have first-hand experience of this, maybe much to their chagrin. CDRH is taking a much more aggressive approach to these inspections and issuing more warning letters and in some cases, even 483 is based on them. I think that's, quite frankly, the reason why FDA put out this particular guidance now.

Jon Speer: Alright, well, that's a little bit insightful. I guess the other thing that kinda raises an eyebrow for me, I mean 200, nearly 250% increase in about a 10-year span for foreign, and you said about 50% for US inspections, right?

Mike Drues: Correct.

Jon Speer: Why is it FDA doing so many more inspections?

Mike Drues: Well, it's a great question, Jon. And clearly, there are a lot of reasons. To make it simple, and to be quite blunt, the simple reality is, and I take no pleasure in saying this, but there are some companies, some medical device companies and the people in them that have done and continue to do stupid things. And when companies do stupid things, oftentimes, that leads to bad press, that leads to recalls, that leads to, in some situations, people being harmed. And so one could argue that, the better that companies do their jobs, in terms of what they should do from an engineering or a biology perspective, the less of aggressive that FDA will have to be.

Mike Drues: Some people in the audience might have a bit of a hard time with that characterization, Jon. But as I've said many times, there's no better way to ensure that we have more regulation in the future than if people do stupid things. On the other hand, that street runs in two directions. There's no better way to ensure that we have less regulation in the future than if companies do the things that they really should do. Does that make sense, Jon?

Jon Speer: It does and I'm just thinking back to the past 12-18 months or so, there's been documentaries, there's been patient advocacy groups, there's been different websites popping up here and there that seem to be constantly pointing out all the bad stuff for the med device industry. And part of what I'm hearing is, and I know you didn't... I'm not trying to put words in your mouth, but in some respects, it's speculation, I suppose, but in some respects, the increase in inspections could be partial knee-jerk response based on all this negative press from the med device industry. Is that a fair speculation, do you think?

Mike Drues: Absolutely correct, Jon. It's an excellent point and thanks for the reminder, to not paint an overly broad brush here. Clearly, the vast majority of companies and the people in them are doing the right things, but unfortunately, there are some that don't, and it's kind of like if you have a barrel of 100 apples, it only takes one of them to make the entire batch sour. Anyway.

Jon Speer: Yeah, yeah. We all come across the rule or in our daily life, we may see as a sign posted somewhere, and it says a certain rule and at first, you might scratch your heads like, "Why is that rule there?" "Oh, it's because probably, somebody did that, and so now, they made a rule for the rest of us, even though it was one out of 1,000 people or whatever." But the rules are there for reasons, and it's not always because it's for those people who are following them, it's sometimes for those who maybe didn't follow them, that's sometimes how these things come to be. What do you think the goal of this guidance or I guess, maybe we can go as far as to say program, what do you think the goal of this program is?

Mike Drues: Simply put, Jon, the goal of the program and this is stated in the FDA's press release, which I happen to agree with, is to improve communications with medical device companies concerning corrective actions in response to inspectional observations. In other words, getting a 483 issued. This was actually required of the FDA, as part of the FDA Reauthorization Act of 2017. And this is, if any in your audience want to read the guidance, Jon, this is a very short guidance. It's only about three pages in length.

Jon Speer: Yeah.

Mike Drues: Yeah, simply put, that's the goal, and I think it's an admirable goal. As we'll talk about, whether it's realistic or not, whether it's going to improve the status quo, we'll talk about that.

Jon Speer: To borrow a term, a different FDA regulatory term, and I think some of the notes that you and I were sharing back and forth, it's almost like this is a pre-submission of sorts, but more with a 483 slant.

Mike Drues: I think that's a good way to characterize it, Jon, yes.

Jon Speer: All right. Since we're talking 483 and inspections, these terms may be a little bit new, and I know from folks that I've talked to, sometimes, there's confusion about a 483 and a warning letter, and which ones do I need to respond to, and which ones are for my own edification, all that sort of thing. It might be worth taking a moment to describe some of the difference between a 483, a warning letter, and the types of responses that would be expected from me in those situations.

Mike Drues: It's a great question, Jon, happy to do so. And I also know that you, obviously, do an awful lot of work in this area, so I would invite you to either agree or disagree or add your own examples, if you'd like. But simply put, a 483 and a warning letter is not the same; it's not synonymous. Although, sometimes people use those terms synonymously, regrettably, even I do use them synonymously, but they're not the same. A 483 is just simply... How would you describe it, Jon? Something the FDA finds as part of an inspection that's not quite kosher, as opposed to a warning letter, which is a serious violation may exist. In other words, not all 483s generate warning letters. I don't want to get into the back of the house operations of the FDA, but a 483 would be issued at or shortly thereafter the inspection. But then, as the information is digested, gives this information... If the problem turns out to be a serious violation, then a warning letter can be issued. And in some cases, in extreme cases, if there are real problems, this is when the company might even be put under what's called a consent decree, and that has all kinds of legal ramifications, which we won't get into here, but that's sort of how I differentiate between the two, Jon.

Mike Drues: And one other thing I would add, is just because a company gets a 483, it doesn't necessarily mean they're doing something wrong. I'll give you a quick example. One of the companies that I'm working with now, they got pinged via a 483 on a manufacturing inspection because... Let me explain this as simple as I can. They came up with a better or more efficient way to do something, better than the industry standard. They were not following the industry standard. Upon inspection, the inspector said, "Okay, you're not following the industry standard," and the company said, "Yes, you are correct. Let us explain why." And they had all of the rationale, and the inspector said, "Well, thank you for that explanation, it certainly makes sense, but I need to issue a 483 anyway." It's like we've created disincentives for companies to make improvements, and quite frankly, that's a problem, but that perhaps is a topic of a different discussion.

Jon Speer: And it may be a topic of a different discussion, but it might also actually dovetail quite nicely. Let me add a little bit of my context on a 483. Folks, the number 483 comes from... It is the FDA form 483. It is just the form number. When you have an FDA inspection, you will receive a notice of inspection, which is on form 482, but anything that's captured as a result of that inspection are known as inspectional observations, and those get documented on this form 483. But it might be apropos, actually, to topic, Mike, because it says opportunity for improvement. And I think that if I am a recipient of a 483, to your point, not all of these things necessarily warrant a thorough CAP investigation; some may, some may not. Not all of these things, hopefully, are going to result in any sort of warning letters. And there's no absolute about that, but this might be a good case where if I get a 483, this might be that opportunity for me to engage with agency on this non-binding feedback. This might be a good use case of this guidance document.

Mike Drues: Actually you're right, Jon, and when this particular situation that I just described occurred, this was a couple of years ago, this is prior to this new guidance that we're talking about, so you're right. It could be a good use case for it. And by the way, Jon, one of the reasons why I think you and I make such a good team is because you're very good at the details, at the minutia, at the forms. I'm more of a "I don't care what the form number is, it's the content that's important to me." [chuckle]

Jon Speer: Yeah, absolutely. And sometimes, I think we hear... We rattle off these numbers and maybe it has no importance at all, but I just want folks to understand what the origin of the 483 number is all about, because you are good at acronyms and numbers and codes, and regulatory speak. The other thing that I thought it might be good to kind of explore a little bit, is I think people have a different approach with respect to how they respond to 483s versus warning letters. A warning letter, if you get one, folks, this is serious news. This means that there are some systemic compliance issues that the agency... Or at least, it feels that you have, so your response is mandatory. 483s, I've seen companies be a little laissez-faire about that. To me, a 483, if you get a 483 observation, this may not be the right way to describe it, but I kind of see it as kind of a shot over the bow, it's kind of a warning sign, not to confuse terminology here, but it's something that you should perk up a little bit and pay a little bit of attention, too, and this might be an opportunity for you to improve something within your business, this might be an opportunity for you to communicate with the agency why things are done a certain way. I would take 483s seriously, as well, if it were me, and my medical device company. I would be proactive in responding to the agency with that. I don't know if you have practices that you recommend that would be different or the same on that, Mike.

Mike Drues: Well, I agree 100%, Jon. And as a matter of fact, I take a step further, anything that you get from the FDA, either formally or informally, should be taken seriously. What you do with that information and how exactly you respond, obviously, that's a topic that is gonna be situation dependent, but anything that comes from the FDA should be taken seriously, and that's the purpose of this particular guidance which starts to go into the process, which I think maybe is something that we should talk about. What's the proper guidance set up? In essence, the process that's described in the guidance, here is my synopsis of it. Simply put, a company undergoes a manufacturing inspection, and by the way, this can either be either pre or post-market, most of your audience is probably not familiar with pre-market inspections, because those are typically limited to Class III PMA devices, but the guidance does apply to both. Anyway, you have a manufacturing inspection, as a result of that inspection, you receive a 483. You then need to analyze that situation, understand what the observation was, and most importantly, you need to come up with a response.

Mike Drues: In other words, a justification for why you should continue to do what you're doing or some sort of a corrective action or solution to the problem that they've identified. Once you come up with your response, then you submit that to the agency, not just your response, but you need to submit your analysis. And again, FDA is not requiring you to do this, but this is my SOP. You submit your analysis: This is what we did to investigate the problem, here is why we think it's not a problem, or here is why we think it is a problem and this is what propose to do about it to correct it or to prevent it from happening in the future. And you do all of this prophylactically, kind of like a pre-sub before you implement it.

Mike Drues: FDA then comes back to you with non-binding feedback and we'll talk more about that in a moment, non-binding feedback, on your proposed corrective action or solution. In other words, simply put, does FDA buy your solution? And hopefully, if they agree, then you implement your solution and all is well, and if they don't agree, then you continue to negotiate. At a high level, Jon, that, I think, describes the process. Does that makes sense?

Jon Speer: It does. And I just wanna chime in. Before this guidance came out, at least in my experience, you get those 483 observations and folks, I wanna remind you all, I'm talking to Mike Drues with Vascular Sciences, we're talking about this new guidance document that came from FDA on non-binding feedback after FDA inspections, or certain FDA inspections and I wanna remind folks listening that at Greenlight Guru, we've done webinars on how to respond to 483, we have guidance documents and templates that are readily available for free on our website as well, including a template that can help you with how to respond to 483s. But Mike, in my experience, what happens, you get these 483s and then you've got a finite period of time where you need to start to figure out how and what to respond. And a lot of companies may trigger some internal cap activities and things of that nature, but you're trying to identify the immediate corrections, you're trying to identify what sort of root cause, you're trying to determine an action plan and you're communicating what you're doing to the agency. And historically, I think that that communication oftentimes, it feels like it's... You're sending it to the agency, but it doesn't feel like or you don't really always have confirmation that there's anybody on the other end reading it.

[laughter]

Jon Speer: But I always advise companies, tell the agency you're gonna communicate with them monthly or every six weeks, or some period of time, and then do it. Just because you're trying to show that you're taking this seriously and you're taking the necessary action. I'm kind of a fan of this guidance in that it has the potential to promote more of an interactive or a collaborative type of engagement so that, rather than me, as company, just doing things based on what I think is best, I actually get some feedback, hopefully, from the agency as to the actions that I'm proposing.

Mike Drues: Well, once again, Jon, I could not agree with you more. Another way to ask, I think the question that you just described is, is the process described in this new guidance, is it really new? And the short answer is, absolutely not. As you just correctly pointed out, we've always had the opportunity to discuss plans for responding to 483s, and it's an option that I always recommend, and I know you do as well. But previously, companies could ask for this feedback on their proposed corrective actions, but there was no standardized process, if you will, for FDA to provide that feedback. And so, when we refer to this as a new program, I put the word new in sort of air quotes. All it does is it simply formalizes what was already available to everybody, and what you and I both have personally recommended probably many, many times over the years. And this is exactly why I draw the analogy to a pre-sub.

Mike Drues: As a matter of fact, I go so far as to say, we didn't need to create a new process, we didn't need to create a new guidance, all we needed to do was perhaps, set up a new category of a pre-sub, where a company could do exactly what we're describing here, a 483 pre-sub, if you will. But FDA did it this way. Maybe we should talk a bit about what kind of information does FDA respond with, 'cause that's another thing that I think is gonna be important for our audience to understand.

Jon Speer: No, totally agree. And remind me, before we wrap up, I wanna quiz you. I'm gonna give you a "fact or fiction" here, in a moment, but yeah, let's go ahead and talk about how the FDA might respond.

Mike Drues: Well, now I'm getting a little nervous, Jon.

Jon Speer: I'm just framing you, Mike.

Mike Drues: I hope I can pass the quiz. [chuckle]

Jon Speer: No, I'm just framing you, it's okay, it'll be a fun moment here in a few minutes.

Mike Drues: No, I appreciate that. Okay. Obviously, one of the first questions that folks are gonna ask is, "Alright, we provide all of this information to FDA. What kind of a response can we expect?" Simply put, what FDA says, if the response is "appropriately" implemented, and again, I'm putting the word appropriately in air quotes because this is gonna be contingent on the level of detail that you give them in terms of your response. If your response is appropriately implemented, FDA will say one of three things, they will say, A, your response appears to be adequate. And again, remember, Jon, all of these words are passed by the FDA lawyers before it ever leaves the agency, so it appears to be adequate. The next option they have is to say that it's partially adequate, or the third option would be inadequate.

Mike Drues: Once again, FDA's responses, they appear to be adequate, they're partially adequate or they're inadequate. The important thing to remember, Jon, is if FDA says it's partially adequate or inadequate, then FDA is also supposed to provide some sort of an explanation as to why, and the recommendations that they might suggest in order to improve the situation. But once again, Jon, this is all a negotiation. There's a back and forth here.

Jon Speer: Alright, that's helpful. Now's the time for the quiz that I promised [chuckle] you a few minutes ago. Alright, so Mike, fact or fiction, if I'm a recipient of 483 observation from FDA, how I respond to those 483s could prevent me from getting a warning letter. Fact or fiction?

Mike Drues: Oh, it's definitely fact. I would say, Jon. If you respond to the 483 and you correct the action, it's sort of a spin on the... An ounce of prevention is worth a pound of cure. If we can prevent a 483 observation from manifesting as a full-fledged warning letter, I think the short answer is fact, unless I'm misunderstanding your question, Jon.

Jon Speer: No. Like I said, I was framing you a little bit, but that's exactly, I would agree. And the reason I bring that up is I think sometimes people... Folks, I think you could do yourself a huge favor. Nobody wants a 483 observation, and sometimes, whether you like it or not, it's inevitable, it's not the end of the world, it's not a kiss of death, but what you do next, does matter. And so, take these things serious enough and respond to them appropriately so that hopefully, it doesn't get escalated. Mike talked about a moment ago, 483, the next level of escalation, if you will, is a warning letter, there might be a few other layers built in there, but then it could get to, if it's serious enough, it could get to a consent decree, jail time, fines, all these sorts of things. Things that, of course, we want to avoid, and the way to avoid that is to be proactive as much as you can, an ounce of prevention, and so on. Mike, I know we've covered a lot of ground on this topic, what a 483 is, what a warning letter and that sort of thing. Is there anything else that you think that's worthy of chatting with or talking about today on this topic for the audience?

Mike Drues: So just one or two real quick things, and then we can wrap up with some final thoughts. In terms of response of this, 'cause again, this is another question that I get a lot, and I'm sure you do as well. The company response, the regulation says that we have to respond to FDA in a timely manner. And that phrase "timely manner" is in the regulation, but in the guidance, FDA makes it clear that their interpretation of timely manner means that the company needs to respond within 15 business days. And then from the FDA side, 'cause the company will say, "Alright, we send this to FDA within 15 days, how long do we have to wait?" In the guidance, FDA says they intend to provide this non-binding feedback within 45 calendar days. And again, just like all of the recent guidance, Jon, FDA parses their words carefully here. They don't say that they're gonna respond to you within 40 days, they say that they intend to respond to you within 40 days. Your results may vary.

[laughter]

Mike Drues: Most importantly Jon, is, I have a huge problem with regulatory absolutes like this, whether it's 15 days or 45 days or what have you. Because remember, one thing I mentioned earlier is this process applies to both pre-market, as well as post market inspections. If you have a device already on the market, then obviously, time is of the essence and we need to respond sooner rather than later, but if this is a pre-market inspection and the device is not on the market yet, then quite frankly, who the heck cares how long it takes for the company to respond to the FDA because the product is not out there yet. This is something that we should use our professional judgement for. And one other quick to mention, Jon, is in terms of which 483 does this process apply to? Regrettably, and this is a criticism that I have of this particular guidance, it does not apply to all 483s. It only applies to the more serious 483s. If a 483 is not deemed to be serious then the guidance lays up a few different categories, which I won't get into here. But if FDA thinks that this is not a serious 483, then the FDA is not obligated to respond to the request.

Mike Drues: In my opinion, I have a problem with that. If we submit something to the agency, we have, as a matter of professional courtesy, an expectation of getting some sort of a response in return. Those are just a couple of things. And one other thing to mention real quick, Jon, is if the company chooses not to follow the FDA recommendation, that's fine. I don't follow what FDA says frequently, but what I do do is go and tell them, "Here is why what you're suggesting doesn't make sense, and here's what we're gonna do instead." You can use this process and this guidance to do these things as well.

Jon Speer: I think that's a good tip. I just wanted to chime in a couple of things. The 15 business days... Folks, I've seen it way too many times in my career where it's business day 14 post-FDA inspection or post receipt of 483 observations. And there's a scramble to try to hurry up and put something together. That's not a good practice. Mike is correct that sometimes it's hard to have the type of depth and detail in order to have as thorough response, but do what you can, address as much as you can, at least to plan your next steps and actions within that 15 business day constraint.

Mike Drues: Jon if I can...

Jon Speer: Yeah, go ahead.

Mike Drues: If I can just interrupt, one thing, I'm sorry, because I have some practical advice I run into that situation as well. And listen, haste makes waste. I don't want a company to take their time in making a response, but on the other hand, I don't wanna overly rush them, either. If you're doing all that you can do to investigate a problem, and simply put, you cannot come up with a complete response within that 15 days, I do not take a literal interpretation to any regulation including this one. The regulation does not say that you have to send the FDA a complete response.

Jon Speer: Exactly.

Mike Drues: It simply says you have to send them a response. In that scenario that you just described, Jon, what I would advice to the company is, you simply say, "This is the response that we've been able to come up with thus far. However, because of the complexity of the problem, this is a work in progress and within another week or two weeks, or what have you, we're gonna follow-up with some additional information."

Jon Speer: Great advice.

Mike Drues: That's what I would advice in a situation like that.

Jon Speer: Great device. And then the other comment that I wanted to chime in on is the "serious" 483 observations. And I've heard this, I don't know that this is... I don't think I've ever read where this is officially defined this way, but I've always heard that the order in which the 483s are listed on the inspection observation report that they're listed in order of, I'll say, importance or seriousness, or priority, based on the view of the FDA investigator. Is that fact or fiction?

Mike Drues: That's a very good question, Jon, and to be honest with you, I can't tell you off the top of my head. I would have to go back and look at a number of them and see... But I never thought about that.

Jon Speer: Yeah, I don't know if that's fact or fiction, folks, but it might be urban legend. I've heard that a few times, that the number one 483 observation, at least in the eyes of the FDA investigator, is the most serious of those. I don't know if that's true or not, but anyway, what...

Mike Drues: I can tell you, Jon, because I do spend some of my time doing mock inspections for companies, what I typically do, when I do this. I was in a company just a few weeks ago, when I'm going through the inspection, I will list them chronologically. In other words, "I found this and then I found that and then I found the other thing," and then when I present them to the company, I separate them based on type, not necessarily based on severity, but oftentimes, similar problems can be grouped together.

Jon Speer: For sure, yeah.

Mike Drues: But then maybe some inspectors put it in terms of severity. I don't know.

Jon Speer: Yeah, I don't know, either. I was just curious if you happen to know. Alright, Mike, as we wrap up this conversation on nonbinding feedback after certain FDA inspections, what are your final thoughts on this?

Mike Drues: Just to wrap this up, and again, thanks for the opportunity to Jon to talk about this, 'cause I think this is important for a lot of folks in our audience. Look, most importantly, and people have heard me before, this is gonna be nothing new. Always do what makes sense. And when I say that, always, do make sense, what I mean is, from a biology and engineering perspective. And then let the regulation follow. As long as we can support, as long as we can justify what we do, from an engineering and a biology perspective, I'm not worried about the regulation. I or somebody like me can figure out how to make the regulation work.

Mike Drues: I also wanna remind everybody in our audience when it comes to manufacturing inspections... I don't know if you were a former Boy Scout, Jon, I was actually an Eagle Scout back in the day. Of the Boy Scout motto, "Be Prepared". In other words, be prepared not just to explain what you're doing, but also to defend why you're doing it. And in many cases, I will also explain why I'm not doing something else, whether this is in a manufacturing inspection or in a pre-submission meeting, or anything else. That's a strategy that I take frequently. And you and I, Jon, I know, are both big fans of having mock audits. In other words, have somebody like us come into the company and put our FDA hat on temporarily, and we're gonna go in there and kick the tires. And if you have somebody just come in and say, "Oh, you're doing a great job, give yourself a pat on the back and have a break," with all due respect, they're not doing their job.

Jon Speer: No.

Mike Drues: So this is...

Jon Speer: And they're not doing you favors either.

Mike Drues: Exactly, right, Jon. And I know you're a big fan of the design controls, Jon. We've talked about this many times, but this is the equivalent to in the design controls, the concept of an independent reviewer. Have somebody come in and kick the tires and make sure that all of your systems are working the way you think they're working. At the end of the day, you can spin this as many ways as you want, but the manufacturer is ultimately responsible, not just responsible in a regulatory/FDA perspective, because you might get a 483 or a warning letter or possibly even a consent decree, but you're also responsible from a product liability perspective. In the end, will this new guidance and this new process improve the efficiency of this? Well, clearly, I think it's gonna spur more communication between companies and the agency on the manufacturing side, and I think that's a good thing and as I've said many times, the solution to both problems is more communication, not less. Perhaps this will be a solution to some of the problems, but will it really lead to a real non-sanitized communication? That, I'm not sure about.

Jon Speer: Who knows?

Mike Drues: 'Cause usually, when FDA comes into a company, in spite of what FDA says, "We wanna have good communication and so on," everybody is on their best behavior, everybody... Everything has been very sanitized. Let's just be honest, Jon. That's just the way that it is.

Mike Drues: But anyway... And now, finally, we come full circle back to one of the first questions that you asked, do we really need this guidance, do we really need this process? Well, here's what I would say, Jon, and then we can wrap this up. For those folks like you and I who really know what the heck we're doing and know how to play this game, then I'll be crystal clear. We absolutely do not need this guidance, we do not need this process, we do not need pre-submission meetings, because we've been doing these things for, in my case, for almost 30 years. But regrettably, Jon, not everybody is in the same category that you and I are, and so, those other folks... This is not a criticism, but just simply an observation. They probably do need this. But at the end of the day, I'll give FDA credit, they are trying to foster communication in whatever sanitized ways as they can. And so, I'm optimistic. At the end of the day, I hope this guidance and similar guidances like it will ultimately lead the world to a better place.

Jon Speer: Yeah, and I wanna just chime in. You heard Mike say "manufacture" a couple of times, and I know that term creates some ambiguity for some folks. And let me just clarify, if your name is on the product, you are the manufacturer, just keep that in mind. Take that advice that Mike offered. This is ultimately, your responsibility, so just keep that in mind. Even if you're a software company and then you don't manufacture anything, per definition, from a regulatory perspective, that's gonna still make you a manufacturer of that software as a med device, so just keep that in mind. But I tend to agree.

Mike Drues: That's a good point, Jon. And the way I like to describe it is, without getting into a lot of legalities here, whoever's name is at the top of the label, that is ultimately who is responsible, not just to the FDA, but that is ultimately, who the product liabilities and the attorneys are gonna come after if there's a problem later on. Whoever's at the top of the label is the one that's ultimately responsible.

Jon Speer: Yeah. Alright, well, I think that's a pretty good overview of this guidance document. And I kinda echo what Mike's saying. If you're experienced and you do a good job with this process as it stands, is there anything new in this guidance? Maybe not. But I'm encouraged by this guidance because I think it's trying to foster that collaboration between agency and industry, and I think that that's something that we've been seeing as a recurring theme in past few years from FDA. And as a medical device professional, I'm encouraged by that, because I think for so long, at least in my career, and there's been very much this "throw it over the wall" mentality. Med device does something, they throw it over the wall to FDA, they cross their fingers, they wait, and so on and so forth. Programs like this, I think, are good movement, to see the agency is very keen to try to be more collaborative with agency. And so, from that perspective, I see this as a good movement from FDA. Mike, I wanna thank you for taking time and diving deep into this topic on this episode of the Global Medical Device podcast.

Jon Speer: Folks, you've heard me say it before, I'll say it again. There's nobody better in the medical device industry, when it comes to regulatory strategy. Mike is a great guy to have in your corner, so I encourage you to reach out to him, Mike Drues with Vascular Sciences. If you don't know how to get ahold of him, just search for Mike Drues. You can find him everywhere, on LinkedIn and a number of other medical device industry publications. And if you can't figure out a way to get ahold of him, send me a note and I'll gladly make that connection for you.

Jon Speer: Also, I wanna remind you all that a lot of the things that we're talking about today and on other episodes of the Global Medical Device podcast, of course there is a quality management system implication for this. What is your documentation? Where are your records? How are you managing these things on an ongoing basis? Records are a big part of an FDA inspection, so having a good system where those documents, those records, are organized, categorized, easy to retrieve, it's gonna make your life a lot easier from an FDA inspection standpoint. Frankly, it's gonna make your business a lot easier to run on the day-to-day basis, too. And that's exactly what we've done with Greenlight Guru the only QMS Software Platform that is designed exclusively for the medical device industry, by actual medical device professionals. If you'd like to learn more about Greenlight Guru, I would encourage you to go to www.greenlight.guru, read all about how the best, most innovative medical device companies all over the globe are bringing their products to market a little bit faster, focusing on true quality, while at the same time, addressing compliance needs. Check that out. As always, this is your host, founder, VP of Quality and Regulatory at Greenlight Guru, and you have been listening to the Global Medical Device podcast.


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