Why FDA Rejected Nearly 60% of All 510(k) Submissions in 2013

28 min reading time

jorge ochoa exponent

Jorge Ochoa, Principal Engineer at Exponent, asked the 10x Conference crowd last year,

“What’s the #1 complaint about FDA?” and answered, “That it takes too long, right?”

So in December 2012, FDA finalized guidance on its Refuse To Accept (RTA) Policy, a draconian measure used to shorten FDA response times.

Exponent’s Carrie Kuehn explained if there is a mistake on your submission – any mistake – your 510(k) can get kicked back to you within 15 days without further consideration. The clock stops and FDA gets to say, “You asked for a quick turnaround and you got one!”

Carrie Kuehn: So, what is FDA’s refuse to accept policy? So, FDA developed some criteria for assessing whether or not our 510(k)’s are good enough to even get in the front door. They issued the final guidance in December of 2012 and we’ve now had a year to see how this works, the idea being that better-quality 510(k)’s coming in would lead to faster review times, etc., and all of us have read a report or a blog or an article or two about FDA complaining that the 510(k)’s they get are not of good quality and woe is FDA because they just can’t do our reviews any faster and get us our devices cleared because our submissions are just so bad. So they came up with the refuse to accept policy. The idea at FDA was they want to focus their resources on reviewing really good submissions, not crummy ones, enhance the consistency of their acceptance criteria, and they reported this policy to be about assessing the completeness of our submissions, not the quality of the submission, so…and then they would get back to us in 15 days.

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What have we seen so far? So, there should be a difference, right, between an administrative and a substantive review? RTA is intended to be an administrative review. So is it a device? They have some preliminary questions, you can go to their website and there’s a laundry list of them, but they’re going to look at it and say, “Well, is your widget, even a device, does it belong here? Did you pay your fees? Is the 510(k) [00:01:50] ready for submission? Maybe you don’t need a 510(k) or maybe you should have a PMA. Are you even in the right space?” And then their presence or absence are required components, right? There should be a checklist. Do they have their user fee documentation? Do they have their DCs? Do they have their device subscription, etc.? Resulting in a refuse to accept or a move on to substantive review. It should be pretty straightforward.

Substantive review, we expect it’s going to be our review of the 510(k)’s. It’s the quality of your components, whether or not you have substantial equivalence, going to the AI request and response, the cycle and process that we’re all used to with the review of 510(k)’s, and this should result in a binding determination of substantial equivalence or a failure of that and you move on from there. Marjorie Shulman actually said that, “There will be no evaluation of the adequacy of contents or rationale as part of RTA.” So, what did we get?

So, here’s the RTA checklist, I don’t know if any of you have seen this. It is enormous, it has multipart questions, there are separate sections for different pieces, and it is anything but administrative. If you look through it, there is definitely a blurred line between that administrative or substantive review, and so we’re going to talk a little bit about what happened when this was implemented by FDA over this past year.

So in 2013 FDA received 2965 510(k)’s. They accepted through RTA. This is not substantial equivalence determination. This is just getting past RTA, only 1197 of them. Fifty-eight percent of the 510(k)’s that showed up at FDA’s door were turned back under the RTA guidance based on the checklist that they have. So, what happened? Some of the anecdotes that we’ve seen, there are blogs, you can Google this, FDA Law Blog had a fantastic review kind of looking back, if you will, and there were any number of reasons that kind of baffle the imagination with regard to why these were turned away including failure to indicate whether a vinyl glove had software and had passed the electrical safety standards. There were substantive questions too regarding shelf life. They also turned them away for misprints, pagination problems. I think one of the anecdotes I heard was there were two page 17s and so they turned it away. “It wasn’t good enough, go back, send it to us again.” Failure to state whether a condom was patient contacting. So, just little things like this that kind of baffle us in terms of is this really what RTA should be about?

Real quick, I’m going to actually turn it over to Rob, who’s going to share with you some anecdotes based on his experience filing submissions, and then Jorge is going to talk to you a little about what this failure of RTA, if you will, means for your new product development cycle, and then Rob has some really great suggestions for getting through it. So, Rob, do you want to tell us some of your worst stories in this regard?

Rob Packard: Yes, thank you. I work with several different clients right now, I’m working on some 510(k)’s for those clients, and when you put together a submission for the client and they’re reviewing the records before it gets submitted I get these kinds of questions. They can’t believe that we need to be this detailed, and oftentimes they’ve done a 510(k) submission themselves before and they’re looking at my submission versus the one that they prepared before on the predicate device and they’re saying, “Why do we have so much more detail? We didn’t have to do this before. Why do we need this?” Or I’m asking for information for a certain section and they say, “Well, why? I didn’t need to provide this information before,” and it’s simply because that’s the level of detail that this RTA checklist is requiring. That’s the level of detail that the FDA is scrutinizing submissions. They’re not asking questions about safety and efficacy. They’re asking you to dot your i’s, cross your t’s, and then do it 10 more times, and then it’ll be almost good enough to be rejected.

So, it’s a ridiculous hurdle that they’re asking companies to go through and it’s not meant to be, “Is your submission complete?” This is not an administrative process. This is clearly blurring the ones between an administrative review and a substantive review. But that doesn’t mean you’re going to stop submitting 510(k)’s because you’re not going to stop making new product innovations. And some of these submissions that companies are submitting are special 510(k)’s case, which is just a catch-up saying, “You know, we’ve made these minor modifications over time, we want to catch up,” or the FDA is telling you, “You shall catch up and tell us what changes you’ve made since the last 510(k).” And so it should be shorter, it should only tell you what the differences are, yet we’re still getting really tough questions about things that make no sense, things that shouldn’t even be applicable but they want us to connect the dots anyway.

So when I get these kinds of questions, you need to understand, the FDA 510(k) submission process is nothing like it was in 2003, 2004, even up through 2007. You might be able to figure out what political trigger might have caused all this, but I’m not sure a change the other direction will make it any better. I think the new FDA’s 510(k) process is here to stay and it’s only going to get worse, not better, because the FDA really doesn’t like the 510(k) process. Back to you.

Carrie Kuehn: Jorge?

Jorge Ochoa: Okay, while we turn this on, sorry to be the buzzkill of the day, but who here has been involved with the RTA process in the last year? Okay, who here is in direct charge or participation in new product development? Okay, so I want to talk a little bit about resources.

Carrie Kuehn: I could make that work…

Jorge Ochoa: Okey-dokey.

Carrie Kuehn: There you g
o.

Jorge Ochoa: So everybody should be familiar with this particular…at least this is my version, [00:08:54] version in the new product development [00:08:56], and the reason I brought his up is because we’re always thinking about people, process and product, and the standard of reasonableness went a little bit out the window with RTA, and we’ll talk a little bit about why aside from the politics.

So, Ms. Shulman…Dr. Shulman talked about this to the FDLI at the FDLI conference last year and this is what the FDA saw. So, politics aside, this is the data the FDA saw. They looked back in industry for about 10 years and what they saw is there was an increase in the average number of review cycles, that as far as they were concerned industry was getting worse and worse because they had to intervene more and more in these review cycles. Number two, our reaction time slowed down. So if we got 180 days and 179.5 days, we would come back. So, obviously, it was industry’s fault that innovation was slowed down. The third is that over 80% of the AI letters, when the FDA called up and said or sent you a letter saying, “We need more information. There were inconsistencies in the submission or they were missing some of the admin requirements.” So that’s a pretty big number and it was leveraged to justify this initiative.

And the last thing is there was actually an old RTA checklist. Did anybody know that? Did anybody know it existed, anybody in this room? That’s what I thought. Nobody ever used it. So, we took the baby, the bathwater, threw it out, and started on this process, and it’s actually unfair to put it all on the FDA because we are partially responsible as industry. What is the number one bitching point about the FDA? It takes forever, right? Well, we asked for it. Within 15 days, we’re going to tell you whether we’re going to look at your 510(k) or not. So that’s like your mom when you come in and you tell a lie, “Okay, this is what I’m going to do to you.” So, we participated in that and this is what we got.

So, the reason that the FDA gave is they wanted to reduce a number of review cycles and the total time before devices were cleared. What it means to us in industry is you get one shot at it. Once it gets rejected, clock starts again and you have to come back and there’s another 15 days. The new checklist, this was the criteria, and I’m going to tell you what I think it means to us in industry. It was meant to be a compilation of regulations, of statuses, statutes, guidance, review, everything under the sun, and what ended up happening, instead of finding the efficient intersection of all that data that needs to be put in for an initial review, what we ended up was that slide that Carrie gave us with multipage, multi-question, multipart questions, compound questions that are actually, if you remember logic from your senior year in high school, it was a union not an intersection. So that’s where we landed, and it’s much easier to form a union logically than an intersection. To do an intersection, you actually have to do a little discerning work.

They wanted to create an objective tool to understand the components and if you have a complete 510(k). Couple of things here. What they’re saying with this in my thought process, it’s important to us so it better be important to you. The danger here is who defines what objective is. Is it objective? Who gets to define it? And the FDA does. So there’s very little wiggle room. The last thing, as we stated before, is they’re supposed to be only evaluating the presence of an item, not the adequacy, in principle, so mostly administrative.

The last thing the FDA stated is, “We want to make efficient use of our resources,” which the semi-cynical view that I have is it’s more work on our part. If we do more work, they could become more efficient. So it’s a shifting of the resources, especially early on. It’s much high risk, much shorter time. When you have lesser resources at the FDA, efficiency, looking at a boatload of data with a short amount of time upfront, very high risk, we need to put that into our new product commercialization process. That’s the bottom line.

Is this making sense to everybody? It’s not a free ride. This can have a true impact in how you get your products to market. So how is your new product development process and your projects affected? Well, number one, timing, schedule, budget, resources. If you get rejected, if you get the RTA ding, clock resets to zero and you start again. At the bottom where I said the effect could be cumulative, that’s what I’m talking about. Number two, it’s not an interactive process. What we bought ourselves in those first 15 days is we send our stuff in, stuff comes out, done, we don’t get a chance. So because we were yapping off about, “Oh, we want quick, we want upfront, we want decisions,” that’s part of what we got. No interaction. There’s no limit of the number of RTA cycles, and that to me I think is one of the most dangerous things. It hasn’t come to fruition, we just need to monitor it, but 15 days at a time plus the time in between to react can add up pretty quickly, if you are on a very short timeframe as far as your product development cycle, if you are in hips, knees, spine, where new products, really significant products get launched every five to 10 years, not as big a deal, three- or four-year projects. If you’re doing stents, if you’re doing pacemakers where the technology changes every six months, two or three cycles, it’s 20% of your product development cycle. So it is significant.

Next one is the concept of substantive interaction and the MDD decision. These are actually pretty cool and I wanted to put them in here to show that it’s actually not just a one-way street, is there is now a decision point where the FDA will tell you if this is going to require [00:15:06] exercise with your submissions and require more interaction than usual, and in principle they’re open to actually reversing the first 15 days where there’s no interaction and really getting into the weeds with you, which I think potentially is a favorable thing.

The last one is—and I think they actually did hear us—remember after 90 days they’d stopped the clock and didn’t come into a decision, kicked it out and then you have to start all over again? There’s actually a tool now, the MDUFA decision where if they don’t think they’re going to come to a decision in the 90 days, they tell you and you can continue to work on it without restarting the clock, which I think that actually is a silver lining in this whole process.

The last couple of things I’m going to talk about or the last thing is, even though there’s not a lot of interaction at the beginning, we can create the interaction by talking to the reviewer because now there’s a very specific point where the lead reviewer is going to be identified and then sent to you and be part of the process. So, especially in the tail end, if they’re substantial, is there going to be substantial interaction or you’re going to pass the 90-day and there’s going to be a lot of back and forth with the FDA, and I think this has the potential to be very good, is please make your 510(k) an integral part of your new product realization, new product commercialization, new product introduction process. Anybody here that can give me a sense on whether, when you’re looking at your design control, new product commercialization, PMO office, is 510(k) part of it and is it consistent throughout? Is it addressed at all your design reviews and is it addressed by the team? Because it’s important for the whole team to be involved now because the FDA is looking at all the elements early now.

Anybody here have that inside their companies? Okay, cool. We should. Just a little thought.

Second one: Make sure, and this is something that is…this could be a very useful unintended consequenc
e of this change, is in the traditional model, even in cross-disciplinary teams, people take care of their own element and there are very few things that everybody participates in, and I think that are two elements that are highly underrated by not having participation of multiple experts in multiple fields. One is regulatory submission and number two is intellectual property protection. Those are two areas that are multi-disciplinary, nobody in any company could be an expert on everything that goes into those two areas, and those are the two areas that are most, in my experience, securely guarded by the 510s.

Patents, legal, and regulatory. Train everybody to understand that we work in a regulated environment, how important it is to participate, and that what everybody does especially now in the first 15 days, it’s critical to success, [00:18:09] dimension of success. And the last one is, even more important now, make sure that you train the people that interact with the FDA directly—and that doesn’t just mean your regulatory person on the team, but it means anybody because there will be questions especially when there’s a lot of interaction towards the end of the project—make sure that everybody speaks the language and make sure that people have great communications skills. In my opinion, you don’t only have to be very good technically and know the regulations, but the people that are great communicators are the people that are most successful dealing with the FDA. And I don’t think that all of us have 20 years of time to weed out who the best people are to do that. I think this should be a proactive…it’s a cost on your resources but it’s important.

So, just a little view from the industrial perspective, where this could go. It can affect your resources, it can affect your schedules, it can affect your effectiveness, but it doesn’t mean that’s it all doom and gloom. Rob?

Rob Packard: So, for those of you that aren’t intimately familiar with the 510(k) requirements, there are 20 sections to the contents of a 510(k). They even provide a guidance document that lists the 20 sections and explains what’s supposed to be in each section. So, we’ve provided a graph here and Carrie has done the bulk of the work; I just gave them numbers and rankings. But the top of the list there in the red, they are the two sections that are most likely to result in an RTA. We don’t have the FDA data to back this up. That would be nice to have, but they won’t give us everybody’s 510(k). I don’t know why. And then the second category is sort of the medium risk. These are the areas where you might get an RTA for something in those sections. And then the green section is unlikely, and primarily it’s because the green section consists of forms that you’re going to fill out and it’s much more administrative, so there’s not subjectivity in the eyes of the reviewer or in how you fill things out or provide information. But in the top section in particular, the FDA is asking for a lot more detail than they have in the past. But if your company hasn’t done a 510(k) in a while or you have somebody that doesn’t have a lot of experience, those yellow areas can be problems, and the next slide is a good example of that.

Volume nine, declaration of conformity. Here is a section that’s at the bottom I think of the first page or close to it of the RTA checklist, and they’re just asking you, “Have you completed the FDA Form 3654?” Well, as the name of the form would suggest, it’s kind of boring. All it is is a form where you explain, did you comply with a standard the FDA recognizes or did you deviate from it and if you did, explain how. Well, it’s a long form. You have to submit a separate form for every single standard the FDA recognizes, and just like I was saying earlier, the FDA surprises us with how much detail they want. If somebody submitted a lab report for testing and they referenced one of those standards, so it’s only a single mention buried in page 47 of a 200-page report. If you don’t fill out that form, you’re going to get an RTA letter. That’s how easy it is to get an RTA letter. Somebody else’s test report that you didn’t go through with a fine-tooth comb has a reference to a recognized standard so you need to include this form filled out for the FDA.

Another example of a real RTA letter that a client of mine got back, they filled out this form for a whole bunch of different standards but they didn’t fill it out for the ones that were obviously not applicable. So, for instance, if you have a list of standards and some of them are for, let’s say, a wheelchair that is for somebody that can move the wheelchair themselves and another standard is for a wheelchair that is electrically powered, they want to know why you didn’t apply the one that’s for the manual wheelchair for the powered wheelchair submission.

This sort of goes back to the same kind of comments we saw earlier for the condoms that they want to know whether it’s patient contacting. It’s silly obvious questions. We think it’s obvious; the FDA says “No, you need to specify.” They are also saying, “You need to fill up this form.” So here’s a lot of labor that you’re going to put into something that’s absolutely pointless and adds no value, but the FDA says you shall, so you will.

The next slide. Volume 12, the substantial equivalence. This is one of those red items at the top of the pyramid. This is probably the most technically challenging part of a 510(k) submission and it’s the whole reason why the 510(k) process exists. If you are going to submit a 510(k), you have to explain how it’s equivalent to some other device that’s already on the market under a 510(k) or something that existed prior to the FDA amendment. So, it’s a pre-amendment device. It’s something that’s been around a long time, really safe, great track record.

Well, let’s see. If I have a knee implant that was made out of wood back in the seventies or sixties and I have something made out of a titanium alloy now that has all kinds of coatings and special vitamin E added to it, those are exactly the same, right? Everybody wants that same 1970s technology in their knee. So, you can’t even keep a straight face when you say these are absolutely the same. I like to use the explanation of, “Here is the marketing department over here saying how this clinical data shows how everything is totally different from the competitor’s product and the regulatory person of the same company saying how this product is totally identical to the existing product on the market.” Now, if this seems a little bit bipolar for a company, it is, but the FDA says, “Please provide us a tabular document that explains point by point how it’s equivalent or not worse than the predicate device.”

Next slide. So, identifying a predicate, this is probably the first thing that every company ought to be doing. And you might think, “Well, of course I’m going to pick the last device I submitted because we just made a minor change to it.” Let’s say the previous version was hydraulically powered and this new one is going to be electrically powered. So all I did is change the power and, well, I added on a couple of extra features, so I guess I need to do a 510(k) submission. I can’t just do a letter to file saying, “You know, it doesn’t require a 510(k),” but in fact, when you do the analysis of what it’s going to look like on substantial equivalence table, you may realize that your competitor’s product that already is electrically powered is the better choice for predicate. So there’s a lot of strategy that’s involved in selecting your predicate device and you have to be intimately familiar with all the competitor products and how they establish their device was acceptable from a risk and safety and efficacy standpoint, and then you have to make that argument in a tabular form that some FDA administrative clerk that ha
s been there three months is going to understand. So, just picking your existing predicate device may not be your best strategy.

Next one. In volume 11, this is the one that’s going to look about 10 times thicker than you’ve ever seen before. Each of these slides, I have like part B on here, this is part B of the RTA checklist and it’s fairly lengthy. They’re asking for a lot more detail in what will be the device description than you’ve ever seen before, and things that you didn’t think were important they want to know about.

Next slide. And here is the other parts of the RTA checklist, and as we said before it’s a fairly long document. It has parts A through K. And I’ve indicated a couple of points here that might jump out and grab you, like, “Is your labeling device specific? Is there a guidance document that the FDA has for that type of device?” That’s important because they may say, “You shall have a label that includes the following information.” The newer guidance documents that the FDA is issuing now actually do. If you have sterilization, you may think, “Well, I’m going to reference the gamma sterilization or the EO sterilization standard.” Well, if you do anything that’s a little bit out of the ordinary, you could dump yourself into a third guidance document that’s out there or a standard for nontraditional sterilization validation. So the FDA is getting tougher and tougher all the time. Every single time somebody has a recall, the FDA looks for what more regulations can we throw at them. So it won’t get easier, there’s no good hope in sight, but the best thing you can do is try to learn this process really, really well and, as Jorge indicated, train your whole organization because one person cannot possibly do it all. It’s a team effort to get one of these across the finish line. I think that’s it.

Carrie Kuehn: Yeah, I think that’s it. So just to wrap up, I think that the message here is that RTA is not going anywhere, so we need to find a way to, within our processes, within our organizations, accommodate it, cope with it, and try and work our way through it. The hope would be that that acceptance rate goes up, but I think that remains to be seen and, clearly, the line between an administrative refuse to accept review and a substantive review has not been drawn very clearly at FDA, and so it behooves us to do our best to make sure that our submissions are going in.

I think the anecdotes indicate that our submissions aren’t as bad as maybe the failure rate would indicate. It’s that the decisions being made are not necessarily logical or meaningful. One anecdote that recently I read about was that the submission went in, they got an RTA, worked with the reviewer, got the concerns that the reviewer had brought up addressed, sent it back in and got another RTA because the first reviewer was now gone and they got a new reviewer and all the questions had changed. So, I think there are still a lot of challenges I’m hearing. We’d love to hear your stories and answer your questions. Thank you.

Joe Hage: I have to laugh. Jorge in the middle of the presentation said, “I hate to be a buzzkill.” The whole damn presentation was a buzzkill.

Carrie Kuehn: [Laughs] There is hope.

Jorge Ochoa: Drinks at six, man.

Joe Hage: It’s drinks at six. That’s why they sponsored.

Carrie Kuehn: That’s right. That’s why we gave you the drink tickets.

Joe Hage: Okay, our first question is from Brian.

Brian Blachly: Hello. We import blood pressure monitors and they’ve all been complied with by FDA except for one part of our hospital monitor, which is SpO2. We sent that in 6 months ago, we’ve heard nothing. Is that good or bad?

Carrie Kuehn: Sent in your 510(k) six months ago?

Brian Blachly: 510(k), yes.

Carrie Kuehn: So you got past RTA, it went for substantive review, and you have not heard back or…?

Brian Blachly: We’ve heard nothing. We thought we’d have an answer a month ago.

Carrie Kuehn: I would call your reviewer as soon as possible.

Jorge Ochoa: They’re supposed to get back to you within 15 days.

Brian Blachly: Thank you.

Carrie Kuehn: Yeah, so do you know for sure they got it? Because that would be my first question is, did they indicate that they actually received it? Because you should get a letter that says that they got it.

Brian Blachly: That’s not my department. That’s my partner’s department.

Jorge Ochoa: Everybody needs to be trained.

Carrie Kuehn: So, about the training…

Joe Hage: You were saying something about the entire organization, right?

Carrie Kuehn: Let us know if we can help you though.

Rob Packard: The same comments apply to not just 510(k)’s but any interaction with a regulatory body. It doesn’t matter who it is. Do not wait for them to call you. Do not wait for them to email you. If you think they’re going to call you on Thursday, call them on Wednesday. Be polite about it, be professional about it, but don’t wait for them because they are administrative. They have a very heavy workload and they will forget, things get lost, and it’s your fault.

Carrie Kuehn: Yeah, one of the things I would say just to respond to that as well is a lot of the folks that I talk to are actually afraid to call FDA. I can assure you there are some really nice people there. They’re a hardworking people but they don’t always make good decisions as we’ve seen, but you should never be afraid to give them a call and say, “Hey, what’s going on?” They’re not going to show up and inspect you the next day just because you called and said, “Hi, I’m over here,” which I have actually heard people afraid to call FDA because they’re afraid that means they’ll get inspected.

Rob Packard: That’s the IRS. [Laughs]

Carrie Kuehn: So, as Rob said and as he said, that goes with any agency. Don’t be afraid to pick up the phone or get someone like Rob or me or whoever to call them for you and find out what’s going on on your behalf.

Ross Bundy: Hi, we just started our submissions and actually we haven’t done…we will do a 510(k) but right now we just submitted for our pre-submission meeting, and so how useful is that meeting in terms of passing something like RTA and are the folks there that we’ll talk to? Are they well-versed in RTA issues and maybe give some advice in terms of how to pass it?

Rob Packard: The quick answer is it depends. If it is a device that has a predicate that’s obvious and there’s a very similar product on the market, it’s a waste of your time and money. To give you an example, if you go through the 513(g) submission process, which I gave a link for up there, you’re going to wait 60 days for an answer, you’re going to pay a few grand for it, it’s going to be nonbinding, and it’ll probably be wrong. That’s the good news. [Laughs] However, if you have a device that’s totally different and you’re having a lot of trouble identifying a predicate device, and when you call up a consultant they scratch their head several times, you probably need the pre-submission process. I don’t think the 513(g) process is going to be much good to you, but you probably need to still talk to the FDA because you may be headed down the road of a De Novo submission and you’re trying to avoid a PMA,
and you probably don’t want to do this without a lot of coaching and preparation in advance.

Carrie Kuehn: Yeah, I would agree with that. I would follow up with you can still interact with the FDA without going through the pre-submission process. So you can talk to a reviewer in your reviewing branch and get some questions answered, and then you don’t have to go through that. That may answer your questions.

Ross Bundy: They actually advised that we go through [00:34:15].

Carrie Kuehn: If they advise you to do it, then I would do it, yeah. Yeah. Whether or not that’s going to help you with RTA I think is questionable. I don’t think we know the answer to that yet. I think it depends on whether or not the reviewer that would be handling your RTA and your submission is going to be in your pre-submission meeting and I don’t think there’s any guarantee that that’s the case.

Jorge Ochoa: That’s the good and the bad of it. The RTA is much more dependent on the lead reviewer or the individual reviewer. The 513 process is really good for more overall, put your finger in the pool, see what the temperature is. That’s really good for you. If you need that, if you’re in that kind of gray space of technology, then it’s worth something.

Carrie Kuehn: I would also remember what Rob said, and that is that anything in those pre-submission meetings is nonbinding. So don’t be surprised if they come back and say, “Oh, you know what, actually, we’d like to get this additional information.” One of the ways you can avoid that kind of ambiguity is to go into your pre-submission meeting highly prepared with a very specific list of questions. What I usually tell clients is don’t ask FDA how to do it. Tell them how you’re going to do it and see if that’s okay. It’s usually going to be more beneficial and productive that way.

Jorge Ochoa: It’s like going to Vegas. [Laughs]

Joe Hage: Our next question comes from my friend Debbie Black. She’s flown all the way here from Australia.

Carrie Kuehn: Can I fly back with you?

Jorge Ochoa: Drinks at six. Yes.

Joe Hage: I don’t know what her question is yet but give her a nice answer, would you please.

Debbie Black: Okay. I’m from Bionic Products and we manufacture a negative ionizer of oxygen which we export globally, 50-year-old company, and we’ve had TGA approval in Australia for quite a few years. I’m just about to go down the process of the De Novo 510(k) that I learned about yesterday with the FDA and I actually have an appointment with you, Robert, next week, but you probably don’t know that yet. [Laughs]

Carrie Kuehn: Yes, they know.

Debbie Black: But what my question relates to is our particular medical device, we had to fight in the Supreme Court for eight years to prove that we can make the medical claims that we are making in Australia, and it got us to the point where we are the only one registered in Australia and TGA has told us they will not register anybody else, plus we have global patents protecting our science anyway. But, from my discussions so far with the FDA, my intended purposes that I’m allowed to say in Australia I would not be allowed to say in the United States. Well, that actually presents a huge problem because with my websites and international websites, how can we communicate to the consumer in a language that they can understand what our device can do if we have to try and fit within different jurisdictions globally when the Internet goes across so many different regions? I don’t know how to fix this issue.

Carrie Kuehn: Rob will give you some really good advice next week, but it’s a huge labeling problem. And so the key is I think going to be to work with the FDA to generate a web presence that is US-specific. I mean, other companies have had this concern. There are indications overseas, for example, in hips, for example, [00:37:59] resurfacing, it’s cleared overseas and it’s not cleared in the US, things like that. So I think it’s a matter of working with…it’s a labeling and marketing issue that you’re going to have to create one that’s very specific to the US, and then on your other OUS web presence it’s going to need to be very clear that the indications that you’re describing are not cleared in the US. And so it’s a challenge. It’s certainly very complex. Rob, you want to…?

Rob Packard: The only thing I would really add to that without getting into specifics that we don’t have time for would be that your distributors also need to follow you. So, one of the ways to irritate the FDA severely is to sign up a bunch of distributors that create their own websites and do their own thing because you’re the legal manufacturer that’s on the label and you’re the one that’s going to get in trouble with the FDA, not the guy that’s just shipping it.

Joe Hage: Our next question comes from Dick DeRisio. He is with notified body TUV SUD, also one our sponsors, and I’m interested to hear what you have to say.

Dick DeRisio: My comment comes from many years of living the dream doing 510(k)’s and PMAs, and just to reinforce something that Jorge said about getting the right people with the right expertise, since a lot of people here are involved with new product development, often what would happen is the R&D group would keep regulatory out of it until the very end, until they started throwing all the reports to them, and I ran QARA for many years in companies. The fact is they miss the sizzle of going to clinical advisory boards, meeting with the key opinion leaders who are talking about the new technologies, and they never had a chance to get excited and find out why they could support the indications and claims. So whether it’s a quality engineer or a regulatory manager or specialist, having them involved at the earliest stages really gets them excited and makes them much more conversant with FDA in terms of the values of that device.

Carrie Kuehn: Yeah, actually, one of the things we wanted to do at 10x and there just wasn’t enough warm bodies to do it but it’s still something that we want to promote, and that is what we call kind of your blue-collar regulatory—it’s kind of our term for it—and that is training your operations and manufacturing and quality people to understand their role in the regulatory process whether it’s submissions or compliance. We’re not trying to train everybody to be a regulatory specialist. Not everyone likes to read the CFRs at bedtime like Rob does, and I wouldn’t know anything about. But having a basic understanding of their role in the quality system, in their role of generating those reports for your submissions so that you can get past RTA, just having a general sense of it, can change how they think about the work that they do and lead to better overall compliance both from a quality system perspective but also lead to greater efficiency. So I think it’s a really good point, is that regulatory shouldn’t be relegated to the regulatory space only, it should be pervasive throughout your organization.

Jorge Ochoa: If you have a guy or a lady at the end writing a 510(k), RTA City, absolutely.

Rob Packard: I wanted to add one more point. I like your comments about getting regulatory involved early, but I actually started out in R&D, so the last thing I did in my career was quality and regulatory and I think that’s benefitted me tremendously because I can walk into design meetings and I speak their language, I think their way, I’ve done their job, and I can help t
hem do what they’re doing as well as teach them what I do. But I know that regulatory pathways and regulatory strategy is not all that exciting to the R&D team, but when I can give them a list step-by-step of “these are the tasks that you’re going to have to do for verification and validation, and I can guarantee you it’s 100% of the list, I won’t add on more later,” that’s really helpful to them. It’s their yellow brick road. All they got to do is stay the path and do those tasks, and if I can give it to them before they’ve decided what the design solution’s going to be, whether it’s going to be battery-powered or line-powered into the wall, that’s extremely valuable to them because they can say, “Well, which solution will be easier to pass that test?” because I already told them the tasks. And so I’ve actually had several R&D people say, “This is fantastic. I’ve never had one this good before.” Well, that’s because you asked for it a week before you want to submit. It’s not a checkbox in your technical file or your DHF. It’s something that’s supposed to help you plan your whole entire design project, so if you don’t do it early enough it doesn’t have much value.

Joe Hage: The good news for all of you and those of you watching is Rob is really good at what he does. He leads our QARA subgroup, which in my view is our best subgroup for the entire group. He pours himself into it every week and writes something really, really meaningful, so all that goodness means he’s really really busy. The bad news is I don’t get to hang out with my friend on Skype so often anymore. So, Vizma, you had a question.

Vizma Carver: Sure. Hi, and I just spent a year inside FDA as an industry expert as part of their entrepreneur and residence program, and yes those challenges are there. There’s also an interesting dynamic of when we were starting to just pitch some of the ideas in the [00:43:47] pre- and post re-balance, which was one of the cohorts I lead, and it was interesting to see how much pushback came from industry to not change it, because they use FDA as their legal buffer of once it’s approved by FDA we have less legal cases against us. So just to put a little bit of one of the reasons FDA keeps having all of those “more data, more data” is that they’re the ones that are dragged down in front of congress, not everyone behind the scenes, and industry then wants to continue to use them. So just giving that perspective as they’re making these regulatory changes and these guidances that are coming out as part of that strategic plan that we helped them make for this year – that’s also behind the scenes.

Carrie Kuehn: Yeah, I think when it comes to doing a 510(k) versus a PMA we’d all prefer the 510(k), please, because you don’t have time to clinical trial. I will say as someone who works with clients in adversarial situations where they’re either being sued or they’re in other adversarial situations that getting your device cleared by FDA does not really give you a whole lot of buffer against liability or litigation. PMAs, you get to deal with the…you get a little more protection under preemption, but with the 510(k), getting your device cleared, it rarely provides much of a speed bump. So, I think while that might be some motivation for industry pushback, I think that the greater motivation, and this is just my personal opinion, is given the choice of doing a clinical trial and spending that time and money and burn rate versus a 510(k), the 510(k) as much of a pain as it is and as much of RTA is a speed bump now, again, it’s still a more timely and more efficient pathway to market. So, I think there are a number of reasons for that pushback.

Joe Hage: Rob, you told the story about how the bipolar organization has a marketer saying, “Brand new, fantastic,” and regulatory saying, “It’s completely like the other thing.” Ed Black is, as you know, on our medical devices group advisory board and he’s my go-to for matters relating to reimbursement and health economics. And he participated in a workshop yesterday where he showed two triangles, one of them pointing up, one of them pointing down, and he was making a comparison of the things you need for FDA and the things you need for CMS, and I wondered if I could ask Ed to comment on the presentation and what challenges and what possible solutions. You know, finish us off here with some good news. [Laughs]

Ed Black: The fun of my job is telling entrepreneurs their new technology won’t get paid. That’s what people like I get paid to do sometimes. The comment I made, and Doug Limbach was here, it came up I think in the course of talking about the difference between patent protection, working with a patent office, working with the FDA, and working with the CMS, is that there are predicate devices that help you get through FDA clearance. That can hurt you when you try to get intellectual property patents that get even more confusing when you describe them differently to CMS, and you have to be careful when you talk to three federal agencies who all don’t necessarily talk to you until you leave an audit trail that could come back to bite you.

And the other thought was that regarding the triangles I show is that the FDA and all the work that you do to get a product clinically approved is focused on isolating all the other variables outside of an equation to demonstrate that your technology does exactly what it’s designed to do so you can meet that requirement for being safe and effective. But, when you take that technology into the real world and health plan medical directors look at that and try to figure out what that’s going to mean to the populations they cover, they look at this from a completely different perspective, and they know that when you take your clinical trials to the best university medical centers and the best surgeons and others, they aren’t the ones who are going to be using the equipment once they approve for coverage within their service areas. So there’s a completely different view of the world when it comes to covering something because not everything that is safe and effective, which is the mantra of FDA, is reasonable and necessary for treating any particular medical condition, which is the harbinger of Medicare and third-party payor coverage. They’re the left and the right arms of the federal government. They just look at the world much differently.

Carrie Kuehn: Yes, great points.

Joe Hage: Anything to add to that? Doug, did you want to add a comment? Okay. Well, in that case, I have some good news for everybody. It’s lunch time. And before we go, I’d like to thank my friends Jorge Ochoa, Carry Kuehn, and Rob Packard. Thank you.

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