CDRH Proposed Guidance for FY 2023

December 21, 2022

GMDP-header-Mike Drues (1)

What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? 

Today’s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.

Today’s conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.

In this episode, you’ll hear what Mike has to say about what the FDA CDRH has on its A-list and B-list for the fiscal year 2023, what isn’t on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines.

Listen now:

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Some of the highlights of this episode include:

  • What the CDRH proposed guidelines for fiscal year 2023 are about and why it’s important to think about them

  • Things that stick out on the FDA’s A-list of guidelines

  • Items that are surprising or exciting on the A-list

  • What is on the FDA’s B-list of guidelines

  • What’s missing from the A-list or the B-list

  • How collective wisdom is shared across various organizations

  • Whether the FDA should be giving guidance to help companies get products to market

  • The difference between draft guidance and final guidance

  • Identifying changes between versions of guidelines

  • Whether you have to do something if it’s in the guidelines


Mike Drues LinkedIn

FDA Website: CDRH Proposed Guidance’s for Fiscal Year 2023

RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)

MedTech Excellence Community

Greenlight Guru Academy

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Memorable quotes from Mike Drues:

“Not to be too arrogant here, but I’m very proud of the fact many of the things that I’ve done in submissions over the years, whether it’s with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”

“That’s why there’s a guidance document database, so you and I don’t have to memorize such esoteric trivia.”

“It’s really not FDA’s job to help a company bring a product on the market.”

“All guidance, indeed all regulation, is very evolutionary. It’s a work in progress.”


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 in companies.

Jon Speer: Hello, and welcome to the Global Medical Device Podcast. This is the founder of Greenlight Guru, Jon Speer. And joining me today is a familiar face and voice on the Global Medical Device Podcast, Mike Drues. Mike is president of Vascular Sciences. So Mike, welcome back.

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

Jon Speer: Absolutely. So today we're going to dive into CDRH proposed guidances for fiscal year 2023. I know we've done... You and I have talked about this maybe a time or two in years past, but maybe a good place to start before we dive too deep into the details of the proposed guidances from CDRH is, what is this all about? Give folks a little bit of context or a high level summary of what this is, why we're talking about this topic.

Mike Drues: Well, great question, Jon. And as always, thanks for the opportunity to talk about this with you and our audience today. Simply put, let's be honest, Jon, the topic of guidance documents to most people with an IQ of more than five is going to seem unimaginably boring. But I'm hoping that in the traditional Jon Speer, Mike Drues style, we can spice things up, and I have a few things to add to the discussion as well. But basically, you're right. This is something the FDA does typically on a once- a- year basis. They put out a list of what they think are the priorities for the coming year in terms of guidance documents, and that's exactly what they put out just about a week before we are doing this recording today. FDA did publish, more specifically, CDRH did publish their annual priority list for guidance documents. And we can provide a link to that list for our audience as part of the resources for this podcast. But basically, FDA divides these into two groups, the priority A group, and the priority B group. These are the guidance documents that FDA intends to develop in the coming fiscal year 2023. The difference between the A list and the B list is that the A lists are the prioritized guidance documents that FDA intends to publish in the coming year, whereas the B list are the guidance document that FDA intend to publish as resources permit in the coming year. So, the A list are the number one priorities, and the B list are the ones that FDA will do depending on time and resources. And of course, Jon, as you know, that like all regulation, this is all subject to change.

Jon Speer: Sure.

Mike Drues: If something like another COVID, for example, comes along, then that could change the calculus here tremendously. But that's basically the purpose. And just one last thing to mention, Jon, and then I'd be happy to hear your thoughts, so we can move on to the next question. In terms of how FDA has done in the past, have they achieved their goals? Well, if we just look at the current year, 2022, CDRH intended to publish 23 guidances, of which they actually published 13 of them. That's about a 57% success rate. 10 of them were on the A list, and three of them from the B list. That's just a little bit of recent historical perspective as to how FDA has been performing. And I think, Jon, that's a fair game to mention in our discussion here because obviously one of FDA's most important jobs is to judge a medical device company. In other words, make sure that the company is doing what they say they're going to do, and support what they're claiming and so on. Well, I think Jon, that street runs in two directions. If FDA says that they're going to do certain things, then we should hold them accountable for doing those things. And when they don't do those things, we should remind people of that.

Jon Speer: Yeah, absolutely. Folks, as Mike mentioned, we will provide a link to the CDRH proposed guidance for fiscal year 2023, so that you can peruse and read through that at your leisure. I've had a chance to do so myself, and as Mike mentioned, it's sort of split into the A- list and the B list. Let's get into some of the details. What is sort of the, I don't know, theme, but what are some of the things that stick out to you on the A list?

Mike Drues: Well, on the A list for the moment for the coming year, just ticking through the list very quickly, and then I'll emphasize the ones that I personally think are the most important. And I'm going to go through these in the order that FDA presents them. Re- manufacturing of medical devices, they're going to update that particular guidance. Okay, fine. That's not a big concern of mine. The next two are big concerns of mine, Jon, and these are both related topics that you and I have talked about in several podcasts having to do with COVID, and specifically the emergency use authorization. The first is the transition plan for medical devices that fall within enforcement policies issued during the COVID public health emergency. And the second is transition plan for medical devices issued Emergency Use Authorizations, or EUAs, during the Coronavirus disease 2019 public health emergency. The second and third on FDA's priority list are both COVID related. And you and I, Jon have talked about this. I think this is obviously very, very timely, and we can provide links to our other podcast where we dig into those topics in more detail if we want to.

Jon Speer: Sure, absolutely.

Mike Drues: Just to complete the priority list, cybersecurity in medical devices. Cybersecurity, Jon, as you know, and as we've talked about before, is a big concern for a lot of companies today that are developing software components of existing devices, or Software as a Medical Device, SaMD. This particular guidance focuses on quality system considerations for pre- market submissions when it comes to cyber securities. There are now a number of guidance that FDA puts out in the general area of cybersecurity. This particular one is focusing on quality. And I know as a quality guy, Jon, you probably have opinions on that one?

Jon Speer: Right.

Mike Drues: Just closing off the list is content of pre- market submissions for device software functions. This is yet another topic that you and I have delved into in deep in other podcasts. Devices that contain software that perform these software functions, fostering medical device improvement. FDA activities and engagement with the voluntary improvement program. Well, I don't know about you, Jon, or how familiar you are with this voluntary improvement program, but in the regulatory world, this is about as touchy feely as you can get. In my opinion, this is just put out there by the FDA to make people feel good. But from an engineering or a regulatory perspective, I've seen the draft of this. There's nothing in there of real substance that I think medical device companies need to worry about. And then, the last one on the A list for final guidances, which I think is a revision long overdue, is the final guidance on the Breakthrough Device Program, or the BDP. Something that you and I have talked about many times before. And to be honest with you, Jon, although I think that the BDP program has been an extraordinarily successful program, kind of like the Orphan Drug Program, it's become too successful. And we really got to put some limits on that. I think that FDA now is awarded as of late, north of 500, I think approaching 600 BDP designations, which I think is way, way too many. And I've made a number of specific recommendations on how we should tighten that program up because I personally believe that a BDP, unlike a 510( k) or De Novo or PMA, where you just pick the regulatory boxes and you get a 510( k), or a De Novo, or a PMA, a BDP should not be that way. It's not everybody shows up gets a trophy. It should truly be for the best of the best. Those are the priorities for finalizing guidance for 2023 on the A- list. And then just very quickly, FDA, putting out new draft guidances in the following areas. The voluntary malfunction summary reporting program, this is something that you and I have talked about in the context of the PMA, for example. Clinical considerations for medical device pre- market submissions for opioid use disorder, and selected updates for guidance for the breakthrough devices program, I just mentioned that. And then finally, the electronic submission template for De Novo request submissions, which again, is long overdue. And I think we need that for pre- subs, I think we need that for everything. I can't tell you how many of my customers, Jon, when I say to them that in order to make a submission for a pre- sub, for example, or a BDP, you have to take your file, put it on a memory stick, put it in a box. In my case, send it across the country, have them take it out of their box, and put it into their computer. You don't have to have a PhD in engineering, Jon, to appreciate that that's nuts.

Jon Speer: Yeah, especially-

Mike Drues: How is it that we're almost into 2023 and we're still operating that way? It just boggles the mind. That's a quick run through of what's on the A list, Jon, before we move on to the B list. Any thoughts on any of those?

Jon Speer: Well, a couple of things that stick out, obviously the COVID, the transition plan. This is something as you mentioned, you and I spoke about. And I guess I want to remind folks listening who maybe have devices that were brought to market under the EUA for COVID-19. I wouldn't wait for FDA to develop this guidance document to start making your plans. In fact, hopefully you've already been working towards the 510( k), or De Novo, or whatever the appropriate and applicable pathways are for your product to keep those in the marketplace. So, those things stick out. And as you know, I think the breakthrough, not everything should be considered breakthrough. That seems like floodgates are open. But I guess I'm curious, anything that's surprising or concerning or exciting in your point of view on the A- list priorities?

Mike Drues: Well, I guess you have to be a regulatory geek to consider this exciting, but-

Jon Speer: Well, we're trying to spice it up, Mike,

Mike Drues: But I will be curious to see what of my or other people's recommendations that FDA takes into hand in terms of the BDP program.'Cause like I said, it's become probably too successful, and I think it needs to be tightened up. In terms of your comment on the EUA, I just want to reiterate one thing that you and I talked about in some of our podcasts on that topic, because it's a recurring problem to many of my customers. I had a new customer just come to me within the last couple of weeks who got an EUA on a device. And now in order to keep that device on the market, they submitted a 510(k). FDA came back with a 23- page additional information request. I don't know probably some 50 or 60 items on it where FDA was looking for more information. And of course, that's when the company came to me. They didn't come to me before that. They came to me after that and they said, " Mike, we don't understand. We got the EUA. Why are we having these problems with the 510( k)?" And I said, " Simple, because an EUA, this does not equal a 510(k). The EUA is a temporary authorization. It is not a clearance or granted like a De Novo or approved as a PMA. The bar for the EUA is demonstrably lower than it is for a 510( k) or De Novo or PMA." That's something that our audience, I think needs to keep in mind.

Jon Speer: Yeah. Okay. Well, let's talk I guess, high level a little bit about what's on the B list per what you shared a moment ago, at least for fiscal year 2022. There were some of those B list items that did get published, so one can expect maybe that some of these B- list items will get in front of us in industry in this fiscal year as well. What's on the B list?

Mike Drues: Correct. Well, for the current year three guidances from the B list were published, so we'll see what happens in 2023. But what's on the B list in terms of the final guidance, this first one is a bit esoteric. Peroxide- based contact lens care products. Obviously, that's going to apply to a very, very narrow part of our industry. But what that means to me when FDA finalizes a guidance like this is that there have been problems in this particular area, and therefore FDA is putting out a guidance which they should in order to try to prevent these problems from happening in the future. You always have to ask yourself when it comes to regulation or guidance in particular, why is FDA putting these things out? More often than not, there're putting them out because there have been problems in the past. Most of the times guidances don't come out prophylactically. I wish they would, but they're trying to prevent problems from the past. That's the only one that's on the final guidance for the B list. Other draft guidances, a couple of them in the category of biocompatibility. You and I have talked about biocomp many times before. As our audience knows, I'm a subject matter expert for FDA in a few different areas, one of them being biocompatibility. I think this is going to be a particularly important guidance, chemical analysis for biocompatibility assessment. Basically, the idea here is to use the chemical analysis of material as a surrogate biomarker, if you will, for actual in vivo animal cytotoxic or some other kind of testing. This is a question that I get from my customers a lot. I think it's going to be a good guidance for the audience to take a look at. Marketing submission recommendations for change control for specifically artificial intelligence and machine learning- enabled devices. Which, when you think about it, Jon, and you and I have talked about AI before as well, change control when it comes to artificial intelligence. Well, by its very nature, AI is supposed to be changing. It's supposed to be evolving, it's supposed to be changing over time. But with this archaic concept that FDA instituted a few years ago of this locked algorithm, we've essentially sucked the artificial intelligence out of the device, so it'll be interesting to see... I don't anticipate anything new here, Jon. It's going to be a rehash of what people have been talking about. But that's on the B list, evaluation of sex- specific and gender- specific data in medical device clinical studies. Okay, that's a politically- correct kind of a thing to look at today. The accreditation scheme for conformity assessment pilot program. That's something that maybe we can talk about in the future when we get a little further down that road. Basic safety and essential performance of medical electrical equipment, and medical electrical systems, and so on. Basically, it's an update of the basic electrical safety requirements. And then finally, biocompatibility testing for medical devices. This is also part of that ASCA pilot program. A pilot program, I think we did a podcast on that last year, I believe. Jon.

Jon Speer: I believe so too.

Mike Drues: Maybe we should do a refresh on that because now we have electrical safety biocompatibility, some clinical stuff coming into that. This is going to be something that I think our industry is going to be taking advantage of more and more as we continue. That rounds up what's on the list of guidance from FDA, the A list as well as the B. Any further comments on that second round of guidance as I mentioned?

Jon Speer: Just a couple of reactions. The chemical analysis for biocompatibility. To me, at least reading the title, that sounds very encouraging. Maybe so much so that it might even harken back to a point in time where one used to be able to leverage some chemical analysis much more so from a biocompatibility substantial equivalence point of view, and then maybe where we are currently. So, I'm kind of anxious to see what that guidance has to hold. And then, to your point about the AI machine learning, the way that's handled today from an FDA perspective is... Well, doesn't really lend itself for the software to truly be AI or machine learning, so I'm optimistic that hopefully there's some things that will find its way into this draft guidance as well, that will allow industry or products that have AI machine learning to actually be a step closer to being AI machine learning products. Those seem like some exciting things. And then the ASCA program, it seems like there potentially will be a lot of momentum on initiatives to further support that initiative as well.

Mike Drues: Well, one of the things I would just amplify what you just mentioned, Jon, I'll use the AI as an example. A lot of people ask me, " Well, where does FDA get the ideas and the information that go into these guidances?" A lot of people think that it comes from the FDA. In most cases, it does not come from the FDA. In fact, it comes from us, it comes from industry. And what FDA often does, and I've been involved in this process as an FDA consultant many, many times, is FDA will take a look at the first few submissions in a new medical device area, for example, and pick out of them what they like in those submissions, and put them into the guidance. And the reason why I bring that up, Jon, is because while, at least in my opinion, the concept of the locked algorithm, which FDA has adopted largely, and industry has largely followed thus far, is truly an archaic concept-

Jon Speer: Yes.

Mike Drues: ...because it is holding us back. One of the things I'm very proud of is some of the AI software devices that I've been involved with recently do not use the concept of the locked algorithm. And in fact, purposely allow the software to do what it's intended to do. That is to learn, and to change, and to evolve. And obviously, you can appreciate, Jon, these were not always easy things to get through the FDA, but we've got a few of them through now. And I'm hoping that some of that, how we did that, and the controls that we put into place and so on, will go into that guidance.

Jon Speer: That's cool.

Mike Drues: One of the things, not to be too arrogant here, but I'm very proud of the fact that many of the things that I've done in submissions over the years, whether it's with AI or biocomp, or other kind of testing, has actually gone into guidance for the future. Something to think about.

Jon Speer: No, that's very cool. As you look at the A list and the B list for fiscal year 2023, is there a topic, or something that you see that maybe is missing from the A list and the B list?

Mike Drues: Well, it's a good question, Jon. I like questions like that because it forces to look beyond what we're given. Beyond the answer and say, "What is not there?" Obviously, FDA does not publish any public explanation as to how they came up with these particular devices, but if you use a little reverse engineering, if you use a little common sense, you can identify, as I said before, typically, it's where most of the problems have occurred in the past, or where they're getting most of the questions, and so on. So, before I give you my opinion, do you have any thoughts in this industry about what you think is missing, or what would be on that list?

Jon Speer: To be best informed to answer your question, it's almost like I should have the whole list of all of the existing guidances memorized, which I do not, but-

Mike Drues: Neither do I. That's why, Jon, there's a Guidance Document database-

Jon Speer: Exactly.

Mike Drues: ... so that you and I don'thave to memorize such esoteric trivia, like-

Jon Speer: Exactly to your point, I was going to ask you this, but you kind of answered. I was going to ask how does FDA and CDRH determine the prioritization? But we see some trends and themes over the years. We've seen more emphasis on things like cybersecurity and Software as a Med Device. Those usually jump to the top of the list. You highlighted the Breakthrough Device Program and the De Novo. And it seems like, if I recall in years past, there's always some sort of guidance about some type of 510( k) or the safety and technology program, and so on and so forth. I don't see anything that jumps to top of mind, to me anyway, as like, oh wow, this is a glaring omission or deficiency. I suspect things around pre- submission and things. That's something that seems like the industry has embraced that pretty well, but those guidances, at least last time I read through them, seem a little bit confusing and convoluted. And if I recall, something doesn't have a pre- submission template, right? I could be speaking incorrectly. But I know there's a pre- submission guidance for 510( k). I think there's one for PMA, but does it-

Mike Drues: Think you're talking about the RTA checklist, the refuse to accept checklist, maybe?

Jon Speer: Maybe, yeah. But aside from that, I don't know. I don't see anything that's like, oh my gosh, I can't believe this isn't on the list. Some of these are kind of head scratchers like why is this on the list? But to your point, a lot of times it might be a reaction to some issue or trend that FDA is seeing in the industry.

Mike Drues: Well, perhaps Jon, we can spin this question in a slightly different direction. Instead of talking about what guidances FDA should or should not be putting out there, how about asking the question, and I really don't hear anybody in our industry asking this question, but should in fact FDA be in the business of putting out any guidance documents? Because one could easily argue that it's really not FDA's job to help a company bring a product on the market. On the contrary, if you think of the relationship between the company and the FDA like the legal system, where it's the prosecution and the defense, is it the defense counsel's job to help the prosecutor prove their case? Absolutely not. And even if they could, they're not going to do that. Now, don't get me wrong. When it comes to guidances, they'll explain the mechanisms of interacting with the FDA. For example, you mentioned the pre- sub process. I have absolutely no problem with FDA putting out a guidance and FDA should put out a guidance. Explaining, okay, you want to have a pre- submission meeting, here's how you do it, here's what you need to submit to us, and yada, yada, yada. But when it comes to some of these other kind of more technological, or engineering, or clinical- based guidance documents, should FDA be telling companies, for example, what kind of engineering or biological tests that they should do to show the safety and the efficacy of a medical device? In my opinion, Jon, as a professional biomedical engineer, I don't need, I don't want, I don't expect FDA to help me do that. If they want to offer me some suggestions, I'll be happy to take those under advisement. But at the end of the day, just like a good surgeon, a good surgeon is responsible for knowing what they're doing. I don't know, Jon, that's probably a different spin on this than a lot of people in this industry would think. Most people want to be led like sheep. Told what to do, do this, do this, do this, and don't think about anything, just do it. But any thoughts on that?

Jon Speer: It reminds me of things that you and I have chatted about in the past. I think a lot of folks in industry, almost like to the FDA as there's kind of like a student- teacher kind of relationship. I think this is a metaphor that you've used where I turn in my assignment, and I'm waiting for FDA to give me my grade. I think as long as this sort of behavior is perpetuated or continues with CDRH, I think it's going to allow that relationship between industry to continue. The industry, as long as FDA keeps saying, here is new guidance for this, and this, and this, and this, our industry is going to kind of sit back and say, " All right. Well, let's sit back and wait and see what FDA's going to tell us to do next." It's going to continue the cycle, I think, in some respects. But I am curious though, I know there are other standards organizations both in the US and globally, that might be a whole different topic of a different conversation, but tangential here is obviously these other standard organizations have different focuses and priorities on which they create standards and guidances and whatnot. And some of these are more led by, or industry is more involved with the creation of some of those. But how much correspondence or communication or collective wisdom is shared amongst these other standards, or organizations and regulatory bodies? Do you have any context to that?

Mike Drues: Yeah, great question, Jon. I would say that there is obviously a fair amount of cross pollination, if you will, between the FDA and the other regulatory authorities around the world. With these ISO, and ASDM, and UL, and the litany of other standards organizations. As a matter of fact, as you probably know, many of these organizations have committees that are responsible for developing the new standards. And on the committee, you might have a variety of people from FDA. You might also have a variety of people from industry. And by the way, this is something that I encourage many of my customers. If you're working in an area, make sure that you have somebody, a technical person or a clinical person from your organization being represented on the committee that's setting up the standard because they can influence how that standard is put together, maybe in a way that might be beneficial to you. This is a spin on what I call competitive regulatory strategy.

Jon Speer: Or certainly be in the trenches to understand how the discussion evolved to get to the point of what got put down in the standard itself. So, there's some clarity on the interpretation of things for sure.

Mike Drues: Absolutely correct. Yeah, absolutely correct. Getting back to the previous thread for just a moment. I said that in my opinion, FDA really shouldn't be in the business of using its time and resources to put out a lot of the guidances that they do. That's industry's job. In FDA's defense, there are a lot of people in this industry. Now, again, I'm stereotyping here, I'm generalizing, but there are a lot of people that quite frankly, do not know what they're doing. And I literally mean that. And I'll just give you one of my many favorite examples. We talked a little bit earlier today about biocompatibility in some of the biocompatibility guidances that are coming out from FDA in the next year. Well, as a subject- matter expert for biocompatibility for FDA, I'm privy to seeing some of the biocomp guidances before they come out in draft form. And I remember, I think maybe it was about two or possibly three years ago, FDA issued a biocompatibility guidance focusing on Nitinol. They asked other people what they thought, but they asked me about it, and I said, " This is fine. I have no problem about it." But, I said, " There's nothing in this guidance that was not in my biomaterials textbook that I used as a graduate student 30 years ago." And they said, " Yeah, Mike, you're exactly right, but you would be amazed how many people don't know that." That regrettably, Jon, is I think why FDA does have to put out so many guidances, and indeed why we have so much regulation. Some people might say, " Oh my God, this guy is being very, very critical, very harsh," but we got a lot of people in this business that don't know what they're doing. I had one other quick example, and this is an extreme example I'll admit, but I had somebody come to me once, this was a new customer at the time, and they were developing a permanent implant, a device that was going to go inside somebody's body for their rest of their life. And I was going with them, the checklist. Have you done this? Have you done that? Have you done this testing and that testing? And then we got to the topic of biocompatibility, and I said, " Where are you on your biocomp testing?" And they said, " What's that?"

Jon Speer: Oh my goodness.

Mike Drues: You're laughing, Jon. You appreciate use of humor. Now again, I would like to think it does not take an MD, or a PhD, or an RAC after somebody's name to appreciate that, gee, maybe it might not be a bad idea, if you're talking about putting a device inside somebody's body for the rest of their life, it might not be a bad idea to ask the question, how is the body, more specifically the immune system going to react with the materials of that device? But I guess, Jon, they don't teach that in school like they used to. I don't know.

Jon Speer: I don't know. Anyway, a couple other thoughts. Obviously we're talking about posed guidances the FDA is prioritizing for fiscal year 2023. And when you went through the high level, the A list and the B list on each, there was the A list that were final guidance, and the items that were draft guidance. And then the B list had the same thing, final and guidance. I know the answer because you and I have talked about this, but it might bear repeating for those that maybe haven't heard us talk about this before. But what's the big deal? What's the difference between a final guidance and a draft guidance?

Mike Drues: Yeah, great question, Jon, and thank you so much for bringing that up because this is another constant source of confusion to a lot of my customers, and I suspect a lot of people in our audience. And that is many people including FDA, they try to differentiate between a final guidance and a draft guidance. Well, the simple reality is from the Mike Drues perspective, there's absolutely no difference between the two. I don't care what's stamped across the big letters across the front page, final draft, whatever, all guidance. Indeed, all regulation is very evolutionary. It's a work in progress. Unlike a locked algorithm, it's constantly changing, constantly evolving as we learn more information. I can't tell you, Jon, how many customers come to me and they say, " Mike, we've done everything that is listed in this final guidance, and yet it doesn't seem to be enough." And I say to them in response, Jon, to quote a famous politician, " I feel your pain, but why do you think that final means final? It does not mean final." I can't tell you how many examples where FDA has put out a final guidance. The De Novo, for example, I believe off the top of my head, I could be wrong on the number, but I believe there were two or possibly even three De Novo guidances that were marked final. And yet, for some reason, there was another guidance that came out after the previous final guidance. I've said to FDA many times, as a consultant, " Please stop using the terms final and draft in the context of guidance."

Jon Speer: Just say guidance.

Mike Drues: Yeah, just say guidance. That's exactly right, because it's just confusing people. But unfortunately, they just continue to perpetuate that.

Jon Speer: Well, and hopefully folks listening in industry can appreciate that even though the words create confusion, because think about how we operate within our own companies. We have policies, and procedures, and drawings, and specifications, and whatnot. A whole litany of documents and records. And we put those things under version control because guess what? From time to time they change, and they need to be updated. So, if you have a document or something within your company that has never been revised, then well, there might be an issue with that document. Things evolve and change and interpretation evolves and change. So-

Mike Drues: Speaking of version control, Jon, here's one of my many pet peeves with FDA when it comes to putting out new documentation, including new guidances. If you have a draft version and a final version, or even if it's just multiple versions of the same document, please, by all means, do a professional courtesy of putting a page or a couple pages at the beginning, identifying specifically what has changed-

Jon Speer: Yes.

Mike Drues: ...between the previous version and the current version. I can't tell you the number of companies that I work with where they'll have somebody, typically a low level... I use a graduate student to do this, or an intern, where you will literally take the two guidances and you will go through them page by page, section by section, sentence by sentence to identify where have the changes been made. That is not necessary. That's an insult to anybody's intelligence. Give us a summary of what those changes were. I don't think that's an unreasonable request.

Jon Speer: No, I don't think so. I think it falls under what would be expected of us in industry, right?

Mike Drues: What's good for the goose is good for the gander, Jon. Here's a related question before we wrap this up, or another question that I get from a lot of my customers, Jon, and that is, if something is listed in a guidance, must we do it? How would you answer that question, Jon? If there's something in a guidance that says, do a particular kind of a test or something like that, as a manufacturer, must you do it? Must you follow the guidance?

Jon Speer: Well, I forget this skill sometimes, but as any good medical device, professional, quality, regulatory, what have you, my initial reaction is it depends. But that one is a confusing topic for a lot of folks. It's a question I get asked quite often too, and I answer with this. The regulations state, the thou shalts, the criteria that one must demonstrate. Guidance is helpful because it is an interpretation of that regulation of the applicable regulations. To your point though, that interpretation evolves. The act of getting a guidance document to draft, or final, or any status where it's put out to industry, I can't imagine the red tape in the layers of bureaucracy that it has to go through to get to that point. The reality is, by the time that guidance gets in front of our screens to read, there's a good chance that some of that's outdated, so don't take it as gospel truth. If you've heard Mike and I speak over the years on the Global Medical Device Podcast, one of the things I think we always try to encourage folks to do is you've got to think for yourselves. If a guidance tells you to do something that just does not make sense, and is not appropriate or applicable, then don't just follow it blindly. But if it does make sense, and it describes a methodology, or an approach, or a certain criteria, or what have you, then by all means, lean on that. I think first and foremost, use your head. Think for yourself.

Mike Drues: I could not agree more, Jon, and you ticked off a few things that I'll just real quickly throw some gasoline on for the benefit of our audience. First of all, a lot of people describe guidance as FDA's current thinking on blah, blah, blah. Well, oftentimes that's not the case because guidances can take a long time to come out, and don't even get me started on how many lawyers they have to go through before they come out. But more importantly, a lot of guidances are years or sometimes even decades old. So, to consider that FDA's current thinking may be a bit of a leap. More importantly, Jon, back to my original question, do you have to do what's in the guidance? The short answer is absolutely not. The regulation, specifically the CFR, the Code of Federal Regulation, that's binding. You need to do that regulation if it makes sense. The guidance is not regulation, and this is something that a lot of people do not understand. Guidance is guidance. It's what I like to call the commentary, if you will, on the regulation, but it's not the regulation itself. And it says now on the newer guidance, it didn't say this on the older guidances, but now on all new guidances, it says... I don't have a guidance in front of me, but something like these are FDA's non- binding recommendations, which basically means that sort of legal code speak, it basically means we think that you should do these things that are in this guidance unless you come to us, and you convince us otherwise. As we've talked about before, Jon, when it comes to guidance or even regulation, this is not something to be followed blindly, just like a computer executing lines of code one after another. Always ask yourself the question, does this make sense? Bottom line, even if something is listed in a guidance, doesn't necessarily mean that you have to do it. If it doesn't make sense, then go to the FDA as a pre- sub or something else, and say, " Hey, here's what the regulation says, or here's what the guidance says. It doesn't make sense in our case, or maybe it's not possible in our case, and here's what we're going to do instead." That's the way this game is supposed to be played. At least in my world, Jon.

Jon Speer: Yeah, and I'll add to that. I think me, as a medical device professional, I should take on the responsibility for being aware of what guidances there are out there in CDRH world, and frankly standards and whatnot as well, even beyond FDA. I should have an awareness of what is out there and specifically, what might be applicable to my product. And I should understand where I might choose a path that's counter to the commentary that's described within those guidance documents, so that I can explain my rationale and my approach. That would be advice that I have folks be aware of.

Mike Drues: I agree, Jon, and being aware, as a matter of fact, I don't know if you did this on purpose or not, Jon, but you set me up to give a quick promo for my upcoming webinar with Greenlight Guru in just a couple of weeks on regulatory due diligence. Because what I'm going to do in that webinar is go through a lot of my Mike Drues tips and tricks on how to make sure that you are aware of what you should be aware of before going into the FDA. One of the things I pride myself on, Jon, is before I go to the FDA, I want to make darn sure that there is nothing that FDA knows that I don't know. In other words, if FDA knows about something that I don't know, then shame on me, I'm not doing my job.

Jon Speer: Absolutely.

Mike Drues: And it's amazing to me how many people do not do that preparation when we go to the FDA. And there are a lot of tools out there that you can use to be aware. And when it comes to guidance, there's no excuse. Can you imagine, Jon? I've seen this happen before where a company comes to the FDA for a pre- sub, for example, and they are not aware of a particular guidance that applies to their kind of device or technology. I don't know about you, Jon, but if you needed surgery, and your surgeon was not aware of all of the different surgical options that they had, and the advantages and disadvantages of each, I'm guessing that you might not want that person cutting on you. It's the same thing for us.

Jon Speer: Yeah, absolutely. All right, I'm wrapping things up on the CDRH proposed guidance for fiscal year 2023. What else is important? What should we reemphasize? Or what did we miss?

Mike Drues: Well, in that last theme that we just talked about, Jon, be aware. Be aware, not just of the guidances that are out there now, but be aware, as you and I talked about today, of the guidances that are in the queue for coming out in the future, because this is another opportunity for industry to work collaboratively with the FDA. If you go to FDA with the pre- sub, and you're working in one of the areas that we talked about, for example, artificial intelligence or biocompatibility, you might as sort of a tangential conversation, bring up the new guidance that's coming out and say, " Oh, by the way, I saw that FDA published this priority list for next year, and this guidance is going to be applicable to us in the future. Can we talk about that?" I think that really demonstrates professional competence. And then the very last thing that I'll mention, Jon, just to reiterate something that a lot of people are not aware of when it comes to guidance. Using guidance is a tactical weapon against your competition. This is another example of what I call competitive regulatory strategy. We can do this with the De Novo. We can do this with special controls. We can do this in a lot of different ways. But influencing FDA, for example, to take a test that you've done for part of your submission, and put it into a guidance that then is going to now" require"... And I'm putting the word require an air quotes, because it's in a guidance, so you can't require it. But" require" the test to be done by your competitors. Well, if you design that test in a certain way so that it's difficult for your competitors to match, now you've just put a great speed bump in their route. Using regulation as a tactical weapon, as a competitive weapon against your competition. Something I call competitive regulatory strategy. I do it all the time. Most people in this industry, Jon, at least in my experience, they never even think in those terms. Hopefully today we've taken, as I said at the beginning, what on the surface seems like an unimaginably boring topic, and that is of guidance documents. This can be exactly what gives regulatory a bad name, but spice it up a little bit. Add a little twists and turns, and the examples that you provided, the examples that I provided, hopefully we got people to think about these things in a little bit different way than they did before.

Jon Speer: I hope so as well. And thanks for diving into the proposed guidances for next fiscal year, and diving through some of the details on the A list and the B list. And folks, I want to thank you all for listening to this episode of the Global Medical Device Podcast, and certainly look out for that webinar that Mike mentioned coming up. I believe it's happening in November 2022. If you happen to listen to this podcast after the webinar, that's okay, because all of these things are evergreen on the Greenlight Guru website. You can just go to the greenlight. guru webpage, and you can look through the resources, and see every webinar that Mike and other guests have conducted at Greenlight Guru, or for Greenlight Guru, as well as listen to every single episode of the Global Medical Device Podcast as well, so be sure to check that out. As always, I appreciate you all listening to the Global Medical Device Podcast. This is Jon Speer, the founder at Greenlight Guru. Thank you.

About the Global Medical Device Podcast:


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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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