You Can’t Say That! Medical Device Claims Masterclass

Hey? Good morning, Michelle.

Michelle Lott, RAC: Hi, Sean, how are you?

I'm good. How are you?

Michelle Lott, RAC: Good. I'm excited about this today.

Yeah, I'm excited about it, too. So Michelle and I were talking before the call about a couple of things. And the 1st thing was. you know. there's still time to register for a Med tech Startup school the fundamentals of compliance. I don't know if all of you know about this program, but she's offered a a free 4 week course. It's completely online. It has quizzes. It's very educational, everything you need to know. And so we're going to drop that link into the chat. I want you guys to use the chat vigorously. If you go ahead and start by dropping in what country where in the world you're

you're calling in from? That would be great. Use the chat and the Q. And a. For questions. Use the Q. And a and for chat, use the chat and so we'll try to get to all of your questions during this call. But if we don't, we'll follow up afterward. second housekeeping note is those of you that would like a certificate of attendance. Please drop that in. And then the last thing that she and I were talking about. And this is where we actually met, was in the Medical device Premium Group Medical Device Group Premium, which is a little known secret. They meet every Friday, and I'm going to drop the link in. We have the speaker every Friday. It's usually a small, intimate group, but we also meet every year in May in California for a conference, and that is, that is a fantastic.

networking opportunity among really experienced professionals. And so this this secret group that I'm going to drop in. I invite you all to join tomorrow at 11. We're going to have a speaker. Details are are going to be in the chat. With that we're gonna go ahead and get started. And I'm gonna turn it over to you. Michelle.

Michelle Lott, RAC: Okay. Michelle Lott, RAC: and get in presentation mode here. Michelle Lott, RAC: Okay. Michelle Lott, RAC: so are we set with a presentation. Michelle Lott, RAC: You can see, okay. Michelle Lott, RAC: So today, we're going to talk about medical device claims staying out of trouble with the FDA. And Fdc. Michelle Lott, RAC: Also known as you can't say that. Michelle Lott, RAC: So I'm Michelle. I have been in medical device, regular, regulatory and quality for over 20 years. Michelle Lott, RAC: I actually served a 4 year term as an advisor to the FDA's good manufacturing practices advisory committee.

Michelle Lott, RAC: and then I say, I am a Master Grief Counselor, because, as the regulatory and quality people on this call go, no, you have to do a lot of grief, counseling in regulatory to the rest of your organization, and especially your your C suite, that there are requirements even in the 1st place. Michelle Lott, RAC: and this is my executive team hard at work sleeping under my desk. Michelle Lott, RAC: Sam. Michelle Lott, RAC: So the different types of services I offer, you know, people call me, and they engage with me for anything, just a hey? Call Michelle or the lean team, because I need to bounce some ideas off or ask some questions with strategy to all the way to. We can be your virtual regulatory and quality staff from submission to commercialization.

Yeah, I think this is something that a lot of people don't understand is that they think, oh, when we're going to hire a consultant. It's gonna be this long term contract, or you know. And and what's interesting about lean or Aqa is that it's really flexible service plan. And you know engagement from a very short, you know. I just need questions answered to filling in for maternity leave, or somebody who's out sick, you know. so don't be shy about contacting them. I'm going to drop that information into the chat about how to book a free 30 min. Call give them a call. I encourage you to do that.

Michelle Lott, RAC: Thanks, Sean. Michelle Lott, RAC: So let's get into this. So those of you who see my presentations regularly. Michelle Lott, RAC: This one is very heavy on words and text, because in in a lot of these examples the wording is important. So so bear with me as we kind of build on concepts here. Michelle Lott, RAC: So let's just start with the fundamentals that's going to give us the context to understand the examples that are written up in some of the warning letters that we're going to look at. Michelle Lott, RAC: So if we look at how the Food Drug and Cosmetic act defines a label.

Michelle Lott, RAC: it is as you would suspect, any written, printed, or graphic matter upon the immediate container. Michelle Lott, RAC: So this is like the most basic fundamental level of that is a label. Michelle Lott, RAC: So if we think of it in context of the universe. Now we've we've got, we're on this planet. That is the like. Michelle Lott, RAC: But we're we expand that definition because we go. The Fdnc goes on to to discuss labeling. Michelle Lott, RAC: which is a broader term. Besides that basic package or container label Michelle Lott, RAC: that that expands it to any written, printed or graphic material on any article, any container, any wrapper, and any pro material that accompanies the device.

Michelle Lott, RAC: They go on to say that that this can include things like posters, pamphlets, booklets. Michelle Lott, RAC: and that the term can be referred to as promotional labeling. Michelle Lott, RAC: And it even includes a company's website. Michelle Lott, RAC: So if we look at how the quality management system. Regulation is going to regulate the use of the word labeling. They stick with the food Drug and Cosmetic act. Definition over that of Iso 1, 3, 4, 8, 5, Michelle Lott, RAC: and then Michelle Lott, RAC: some of the comments asked if if FDA, if FDA is going to clarify the term marketing in the context of label and labeling, and the FDA. Did not think that it was necessary to extend the definition to

Michelle Lott, RAC: marketing, because the Fd. And C. Act uses the term advertising Michelle Lott, RAC: throughout, and that it they feel like it's clear that it encompasses promotional materials. Michelle Lott, RAC: Aka marketing materials. Michelle Lott, RAC: So now we see that our our planet of the label has been demoted a bit, and is a little bit more like Pluto. Michelle Lott, RAC: and it's dwarfed in the overall context and spectrum of what is considered label length. Michelle Lott, RAC: But then, when we think of what is label and labeling in the context of advertising and promotional labeling.

Michelle Lott, RAC: it is synonymous with, you know, advertising, marketing, literature, marketing communications. Michelle Lott, RAC: and the regulations around these are somewhat vague with response to the medical devices. Michelle Lott, RAC: So if we look at kind of some some legal definitions of advertising. Michelle Lott, RAC: It is the practice of attracting public notice. It aids either directly or indirectly to progulate idea Michelle Lott, RAC: and then it also results in direct attention to a business product or service. Michelle Lott, RAC: So now we see that we have label and advertising

Michelle Lott, RAC: as a subset of that universe that has become labeling. Michelle Lott, RAC: And so at each one of these levels, we have to think about where our claims fit in to this system. Michelle Lott, RAC: And it's especially important to understand those basic definitions and what all they encompass, because if you don't understand and apply them correctly at the claims level, it could result in misbranding. Michelle Lott, RAC: Misbranding is, if the device and labeling Michelle Lott, RAC: is false or misleading. Michelle Lott, RAC: which means it's not only untrue, but it's forged, fraudulent, or deceptive.

Michelle Lott, RAC: whereas the misleading could even just give a false impression Michelle Lott, RAC: to the reader. Michelle Lott, RAC: and the false impression could result from either you flat out, make a deceptive statement, or you fail to inform the consumer of material facts. Michelle Lott, RAC: So, therefore, the the label would remain silent to like, for instance, specific consequences that may arise from a claim Michelle Lott, RAC: it could also be misbranding if it does not bear adequate directions for use, or if it is over the counter and it doesn't meet the specific labeling requirements for Otc. Products

Michelle Lott, RAC: claims could be considered unsubstantiated in the event that they are misbranding. Michelle Lott, RAC: It is important to substantiate your claims with data, because this can possibly even lead to a reclassification of your product. If your labeling makes previously new and previously unsubstantiated claims, or it promotes the device for purposes or conditions Michelle Lott, RAC: other than currently marketed similar devices. Michelle Lott, RAC: So if we go one step further from this branding, it is adulterated medical devices.

Michelle Lott, RAC: and there are several circumstances that the FDA can consider devices adulterated. Michelle Lott, RAC: you know, namely, that it fails to meet performance requirements, good manufacturing practices, Ide, or it fails to require conform to the requirements in a pre-market approval application. Michelle Lott, RAC: So we don't only have to think about the FDA when you think about how claims are regulated Michelle Lott, RAC: and where they're regulated in terms of label labeling, advertising. Michelle Lott, RAC: because the Food Federal Trade Commission or Ftc. Is also involved

Michelle Lott, RAC: in the oversight of Medical devices, claims. Michelle Lott, RAC: So the Federal Trade Commission Commission is primarily responsible for the claims in all forms of advertising. Michelle Lott, RAC: and their main goal is to ensure claims that are about the benefit and safety are truthful and not misleading and supported by science, whereas the FDA is primarily responsible for claims that appear in the actual labeling on the product being, like the package package inserts and promotional Michelle Lott, RAC: materials. Michelle Lott, RAC: It's important to know that the Ftc. And FDA have got a memorandum of understanding between them, so that the 2 agencies work together when there is possible joint oversight to ensure that they go to the fullest extent feasible underneath both agencies.

Michelle Lott, RAC: So who has jurisdiction for promotional labeling in advertising in that case Michelle Lott, RAC: generally promotional labeling and advertising regulated by the Fd. Ftc. And FDA. Michelle Lott, RAC: The FDA will regulate or have primary jurisdiction over restricted medical devices, whereas the Ftc. Has jurisdiction over non-restricted medical devices. Michelle Lott, RAC: So in the FDA, the center for devices and radiological health will take precedence specifically, the office of compliance Michelle Lott, RAC: in the Ftc. They will look mainly across all advertising for

Michelle Lott, RAC: evidence of substantiation, deception, and if the claims are fair. Michelle Lott, RAC: they look at advertising Michelle Lott, RAC: if they may, they fail to reveal material information, or they make unfair or objective claims with no reasonable basis. Michelle Lott, RAC: So the Ftc. Their goal is to prevent unfair or deceptive acts or practices. Michelle Lott, RAC: They actually have a a very helpful health products. Compliance, guide about how to navigate the boundaries of your advertising, and what their expectations are.

Michelle Lott, RAC: There are cases where both the Ftc. And the Fd. And C. Act may apply. Michelle Lott, RAC: For instance, the Ftc. Has got some guidances on mobile health apps for both how to handle data and how to market your mobile health app and the FDA has got, you know, probably a half dozen or more guidances around device, software, mobile, medical applications, general wellness, and more Michelle Lott, RAC: so.

Let's get into the warning letters. Why don't we go ahead and launch the poll and give you a little breather and while we're at it. Just a reminder that if you would like a certificate please go ahead and So we're gonna launch the poll. It's thinking it's just 3 questions. while that's running. just a reminder. Please read the chat. If you have questions. yeah. If you if you want the certificate of attendance. Please drop your name as you'd like it to appear on the certificate along with your email into the chat. If you have questions for what we've covered so far. Please go ahead and start adding those to the Q&A.

Don't forget to subscribe to Medtech leading voice at medtechleadingvoice.com. and to reach out to Michelle for any quality or regulatory needs, that you may have no question too small or too big. I've dropped the the link for that in the chat as well. So we'll let this run for 30 more seconds, Michelle. Nice to see you. We have a lot of people on the call, and I'm excited about that. Also feel free to put in which country you're dialing in from. And because we like to know and.

Michelle Lott, RAC: So we've got a quite at the international Michelle Lott, RAC: audience today. That's awesome. I really appreciate you guys Michelle Lott, RAC: taking your time. I know it's like late for some of you.

show. It looks like a. Our audience is fairly knowledgeable about this topic. And that they many of them, have 11 or more products on the market. some. But we're have everybody at every stage. So yeah, okay, good group. Thanks. Everybody for joining. Back to you, Michelle.

Michelle Lott, RAC: So if we look at what the different enforcement actions look like between the 2 agencies. Michelle Lott, RAC: Starting with the Ftc. The Ftc. Can send warning letters similar to how FDA does. Michelle Lott, RAC: These are typically not quite to the the level of FDA warning letter. Michelle Lott, RAC: They call out the problematic advertising and marketing language, and then they just require the recipient to correct the Michelle Lott, RAC: the problematic advertising language. Within a certain period of time they can escalate to include, cease, and desist letters and injunctions and restitution as well.

Michelle Lott, RAC: Here is an example where a company received a warning letter Michelle Lott, RAC: because they had there was a treadmill company that said only components supplied by and installed by the company. Michelle Lott, RAC: Were were valid, or to keep the warranty valid. Michelle Lott, RAC: However, Ftc. Says, you know products sold to consumers, even health products sold to consumers. Michelle Lott, RAC: Cannot make claims that you void the warranty for these kind of consumer based products. Michelle Lott, RAC: So Michelle Lott, RAC: and in this case they decided that this was a violation of the Ftnc act.

Michelle Lott, RAC: So they put them on notice, and in that that letter they had to Michelle Lott, RAC: correct the pro, the warranty situation, and all their advertising. Michelle Lott, RAC: and, you know, likely had to revisit the customers that they had denied underneath that warranty requirements. Michelle Lott, RAC: So the FDA has similar mechanisms to communicate with problem companies. Michelle Lott, RAC: They can start with just a notice of violation which is a little bit more informal process for a warning letter.

Michelle Lott, RAC: The FDA can issue a warning letter with or without a prior notice of violation, depending on the nature of the offense. Michelle Lott, RAC: or danger, possibly to public health. Michelle Lott, RAC: So then it can escalate to the warning letter. These typically have stronger language, and then the FDA can take judicial actions that include consent, decrees, injunction, and even seizures. Michelle Lott, RAC: they will issue a warning letter in the under the circumstances. If you make a promotional claim that could be outside your 5, 10 k. Clearance. Michelle Lott, RAC: If you exceed the product's classification exemptions.

Michelle Lott, RAC: if you promote products with unsubstantiated claims or a previous warning has not been addressed adequately. Michelle Lott, RAC: So if we look at some warning letter examples, here's a company, a 1 engineering that makes a what they have listed as a therapeutic massage massager. Michelle Lott, RAC: and in this particular regulation the intended use is specified as to relieve minor muscle, aches, and pains. Michelle Lott, RAC: and the FDA, in this warning letter declared that it is misbranded because they are making claims that it's intended for uses that are different from devices that are legally marketed underneath that therapeutic massager regulation.

Michelle Lott, RAC: and that further, they are also adulterated because the labels and the marketing materials do not have an approved application for a Pma or ide Michelle Lott, RAC: and it's not covered by an existing 5, 10 k. Michelle Lott, RAC: So they're making all kinds of claims for about every cosmetic thing under the sun, across their whole product line they even get into, you know, kind of some far out there claims that would be really hard to substantiate. Michelle Lott, RAC: like enhances. Biological processes stimulate hydrolysis of triglycerides. You know this is a 1-stop shop for all your your health needs lymphatic drainage even sun damaged skin.

Michelle Lott, RAC: and it just keeps going on Michelle Lott, RAC: and on throughout all types of their marketing materials and all of their products. Michelle Lott, RAC: So in this warning letter, the FDA specifies for them to immediately cease activities related to the misbranding and adulteration, and to further Michelle Lott, RAC: cease commercial distribution of the devices. Michelle Lott, RAC: So. But here we go again. So that original warning letter was in November of 2015, Michelle Lott, RAC: however, in October of 2023, the same company for the same products and the same claims gets another warning letter.

Michelle Lott, RAC: So again. The FDA says that they're misbranded and that they're adulterated, because now they have a 5, 10 K. That they put in in 2018, Michelle Lott, RAC: that was cleared in 2019, and it was intended for muscle conditioning to stimulate healthy muscles. But they're right back to their old game, because now they're saying, Yeah, well, we stimulate nerves and muscles, and because we do that, then that muscle contraction creates aesthetic beautification. Michelle Lott, RAC: and they're back to making all of the claims that they were before.

Michelle Lott, RAC: The FDA goes on in the warning letter to say that changing the these body locations and intended uses, the new anatomical areas create Michelle Lott, RAC: a different risk profile than those that were cleared in the original body system. Michelle Lott, RAC: and that the multiple statements that include statements on the website, social media user manuals. Michelle Lott, RAC: all are promoting the use of these systems on areas where there were specifically contraindicated in the 5 10 k. Michelle Lott, RAC: So once again they have to withdraw their product from the market cease their marketing activities and commercial commercialization activities.

Michelle Lott, RAC: So what can we learn from this warning letter? We have new anatomical areas that are constituting new intended uses Michelle Lott, RAC: that result in it being declared misbranded. Michelle Lott, RAC: They are not monitoring the claims or not Michelle Lott, RAC: caring about the claims on their websites or their marketing materials, and then, you know, don't make the same mistake twice, and it also shows that just because Michelle Lott, RAC: you rectify a situation, it doesn't mean that the FDA is not continuing to look at what you're doing, moving forward Michelle Lott, RAC: so similarly.

Michelle Lott, RAC: We have a different company cellular that is also trying to market underneath this therapeutic massager regulation. Michelle Lott, RAC: because the therapeutic massager regulation is 5 10 K exempt Michelle Lott, RAC: and the firm is. But they're making those same claims about like it's stimulating the lymphatic system Michelle Lott, RAC: breaking up congestion, fat congestion. Michelle Lott, RAC: and they also get a warning letter similar to that of the a 1 engineering. But FDA says, hey, this is, your claims are exceeding the class one exemption, and therefore you're no longer 510 k. Exempt underneath this product code.

Michelle Lott, RAC: and then we see in a press release that FDA is actually taking specific and targeted enforcement area efforts against these types of products. And I have seen this across several different product types Michelle Lott, RAC: where FDA is considered is considering risk to public health across different products that are being generally mass marketed directly to consumers Michelle Lott, RAC: that are far exceeding what either their regulations or exemption criteria are. And so you will see, don't make assumptions that just because your competitors are doing it, that FDA is not also following and going to give warning letters to your competitors as well.

Michelle Lott, RAC: So here's 1 of my favorite examples is Owlet baby Care. Michelle Lott, RAC: So they get a warning letter in 2021 that indicates they have this baby smart sock that measures vital signs, including blood oxygen levels and heart rate. Michelle Lott, RAC: Readings, and it gives care, caregivers, alerts about the condition of the infant. Michelle Lott, RAC: the FDA. They were trying to market this underneath a general wellness indication, and have it fit within that guidance document. Michelle Lott, RAC: And the FDA said that this actually should be classified as a medical device, not general wellness, and therefore it requires FDA clearance before it can be sold.

Michelle Lott, RAC: So let's look at how they were marketing this. They were marketing this across, you know. Michelle Lott, RAC: a lot of different platforms, including Amazon, Walmart target direct to consumer. Michelle Lott, RAC: They were making claims about all the different conditions. It would monitor that it will immediately notify you that your baby needs attention, or to go to proactively check on your baby. Because they were, you know, again selling direct to consumer. Michelle Lott, RAC: So since their warning letter they the warning letter says it does not fall underneath that low risk policy.

Michelle Lott, RAC: and they needed to submit a 5, 10 k. Michelle Lott, RAC: So they submit a 5, 10 k. And they finally get clearance in 2023 Michelle Lott, RAC: and the product is called Outlet baby sat, and it is prescription only. So here we have. Michelle Lott, RAC: you know, a specific intended use that is not over the counter. Michelle Lott, RAC: It is prescription only it was a 5 10 k. It has a specific age ranges and weight ranges that are consistent or specific indications. Michelle Lott, RAC: and then they also are for acute and chronic medical conditions. That and the alarms are now set by a healthcare provider, and they're customizable

Michelle Lott, RAC: to this patient population with these conditions. Michelle Lott, RAC: So and this is what makes it one of my favorite in the physical year and annual report for 2023 FDA actually kind of took a little bit of credit for outlet baby care getting a de novo clearance after their 510 k. Because that now you can. They can sell it direct to consumers without the need for the prescription. Michelle Lott, RAC: and the FDA has got it itemized in this report as, Hey, look at what? At all these novel devices that we helped bring to market.

Michelle Lott, RAC: and the way that they helped bring them to market, was giving them a warning letter in the 1st place, and then they're taking credit for them. Going through to 5 decade. The de novo process. I just Michelle Lott, RAC: that entertains me. Michelle Lott, RAC: So what are learning lessons here for the outlet? Michelle Lott, RAC: General wellness cannot make medical device claims specifically, you know, for direct to consumer products. Michelle Lott, RAC: They that there will. There could be multiple tasks available. Michelle Lott, RAC: based on your intended user population. Michelle Lott, RAC: And then the warning letter is not the end of the road. You could have several correct paths to move forward and get back in the good graces of FDA,

Michelle Lott, RAC: and if you're lucky they'll even give you a shout out in their annual report. Michelle Lott, RAC: So Michelle Lott, RAC: if we look at Michelle Lott, RAC: the company irhythm. Michelle Lott, RAC: they get a clearance in 2016 Michelle Lott, RAC: that specifies in their clearance letter, that this is for non-critical care patients where real time monitoring is not needed. Michelle Lott, RAC: and it goes on to say it is not intended for use on critical care patients. Michelle Lott, RAC: So the FDA points out in this warning letter that this Zio Patch system, the website for the irhythm says that it is intended now for near real time monitoring, and if near isn't a word made up by marketers, I don't know what is as a modifier

Michelle Lott, RAC: and they said, it can provide notifications again immediately Michelle Lott, RAC: for high risk patients. Michelle Lott, RAC: So the FDA clarifies in this warning letter that they have now added a new patient population being high risk patients that was contraindicated by their submission. Michelle Lott, RAC: and that these high risk patients need actual real time monitoring, not near real time monitoring. Michelle Lott, RAC: And it goes on because the FDA has a problem now with their technology and the claims around their technology Michelle Lott, RAC: that they because the technology actually has a transmission limit.

Michelle Lott, RAC: and it has for transmitting the Ecg. And reporting to the physician. Michelle Lott, RAC: And when that transmission limit is reached, the device no longer provides that near real time, monitoring in. The further, the directions for use Michelle Lott, RAC: are not adequate for the physician who is receiving these reports to know that the device has hit its transmission limit, and that they're no longer getting reports, and that we're not even near real time anymore or no time. Michelle Lott, RAC: So they had to immediately cease their activities that were resulting from the misbranding and adulteration. So all their marketing collateral.

Michelle Lott, RAC: and then they had to correct the violations addressed in the letter Michelle Lott, RAC: including the notification with the patients. Michelle Lott, RAC: So what can we learn from irhythm? Ensure your claims? Are not inter Michelle Lott, RAC: inferring an additional patient population and not contraindicated with your device and then watch for changes over time and maybe design changes marketing collateral Michelle Lott, RAC: that could have larger impacts. If you're not reviewing against your original Michelle Lott, RAC: clearance or approval. Michelle Lott, RAC: requirements.

Michelle Lott, RAC: sonovo production. Michelle Lott, RAC: This one gets in the Wayback machine a bit in that they have a 5, 10 k. That was cleared in 1991. Michelle Lott, RAC: It was under product Code Kxa. For a 5, 10 K. Michelle Lott, RAC: That was for a painful hip cup. Arthroplasty. Michelle Lott, RAC: That in 2019 they make a design change that where they did not obtain FDA clearance through a new 5, 10 k. Michelle Lott, RAC: And then subsequently, in March of 2023, they get a warning letter, because now they are saying that

Michelle Lott, RAC: that this is instead of just a femoral, resurfacing cup, that this is now part of a total hip system. Michelle Lott, RAC: and then in January of 2024, the FDA goes on to issue a public communication and press release to avoid using their total hip system. Michelle Lott, RAC: Altogether, because of the significant modifications to the device that differ from those that were cleared in that original 5 10 k. Back in 1991. Michelle Lott, RAC: So the warning letter specifies that these are misbranded

Michelle Lott, RAC: because they were not to be labeled or promoted for non-cemented use. Michelle Lott, RAC: They were supposed to be for cemented use only. So this is again, a different type of technology. Michelle Lott, RAC: And the and the FDA says, any non-cemented fixation is considered investigational. Michelle Lott, RAC: Further, it has a coating for cementless fixation. Again, a different technology Michelle Lott, RAC: and that that different technology is contraindicatory to that clearance letter. Michelle Lott, RAC: So they're also adulterated. And and I think that this is interesting, the FDA went on to specify that they have classified this particular type of hip joint replacement

Michelle Lott, RAC: as a class 3 underneath a different regulation and a different product code that that covers this type of technology and fixation. So now not only did they not do a proper Michelle Lott, RAC: analysis of if they needed to submit a new 510 K. They've put themselves into pre-market approval. Class 3 requirements by changing these. This technology in intended use. Michelle Lott, RAC: So again, they have to immediately cease the but the manufacturer and take prompt action. Michelle Lott, RAC: But in that year period between the warning letter and the the subsequent press release.

Michelle Lott, RAC: Whatever action they took. The FDA did not feel like was adequate because they feel like that. They have to warn the healthcare practitioner community that these products are not safe to use. Michelle Lott, RAC: So one of the lessons here is that the FDA never forgets. It would be easy to think, oh, who's going to go back to this clearance in 1991 Michelle Lott, RAC: and read that clearance letter and then give me a warning letter for for this. Michelle Lott, RAC: So the lessons learned from Sonovo always compare against your clearance or approved version of your device. When you're making claims and even design changes, go back to that original source of truth.

Michelle Lott, RAC: Understand those intended use of your device and the the boundary of not only when you need to submit a new 5, 10 k. But when you may be putting yourself into some other type of regulatory classification scheme Michelle Lott, RAC: and misclassifying these changes as a letter to file can have significant consequences. Michelle Lott, RAC: So some secrets to success Michelle Lott, RAC: 1st create a procedure for all your promotional content. That includes your website, social media marketing materials. Michelle Lott, RAC: Make sure it addresses who is involved the change notification process, the change control process.

Michelle Lott, RAC: Includes your social media. Where do the different types of collateral exist? And who is doing or responsible for that revision control Michelle Lott, RAC: review your original clearance and product code for indications and technology. Be aware that changing, patient populations, contact durations, anatomical locations, general wellness, claims, or getting outside of claims that could fit in general wellness, getting outside of Michelle Lott, RAC: specifications for exemptions, and not complying with recognized consensus standards in some cases can all affect your claims and compliance.

Michelle Lott, RAC: Don't misclassify. Design changes as a letter to file. Michelle Lott, RAC: We always look at the whole ecosystem of what's being changed. That includes the claims. Michelle Lott, RAC: the materials, your labels, labeling, advertising materials that may might go with the change. Michelle Lott, RAC: Changes to technology. Michelle Lott, RAC: adding software or app and possibly even how your data is handled or so stored. Michelle Lott, RAC: So create a procedure for all promotional content, including website and marketing materials. Michelle Lott, RAC: Review your original clearance indications and technologies don't miss, classify your design changes, and then I have got a helpful labeling checklist to just act as a guide or a reality check to to make sure that you you look through the most significant requirements for for labeling.

Michelle Lott, RAC: So Michelle Lott, RAC: sean had mentioned my free 28 day course, if you want to do that, or even a legitimate, deeper dive here I have partnered with reps, and I have a Michelle Lott, RAC: 3 part series on how to develop a regulatory pathway assessment. So check that out. If if you feel like that, that would be helpful. Michelle Lott, RAC: Lots of resources on my website. Michelle Lott, RAC: and then we can take your your question. Let me know how I could be helpful.

That's great. Michelle. Before we jump to the questions I have. Well, I have a question. One of the things that I understand is that testimonials from that either show up on social media or that are on the website or can be problematic, that the FDA doesn't really trust testimonials, and that they can be disguised claims any comment on that.

Michelle Lott, RAC: They can be described, you know, not only disguise claims, but you know, claims around safety and efficacy that are not supported. Michelle Lott, RAC: and you have to police your own social media. Whether you wrote it or not, you know you can't do. You can't obviously take down things that other people posted on their social media. But I believe it was fairly recently that the FDA issued a guidance or some other type of communication about how to correct misinformation. Michelle Lott, RAC: And like, perhaps you can respond to those people. On their own social media of like Oh, hey!

Michelle Lott, RAC: You know the products not actually cleared, for that is cleared for this, you know, etc. But yeah, they they issued a policy recently for how to handle those types of situations. And and they're calling it, you know. Misinformation.

So that's kind of a 3rd category misbranded, adulterated, and then misinformation. And I think that's that's pretty interesting. If we skip to the questions that were submitted. do the promotional materials for medical devices ha! Have to have the term restricted device on it. if it is or not.

Michelle Lott, RAC: They do not have to bear that term. That's just how that who's going to take jurisdiction 1st or primary will be decided if there is a problem with your marketing materials.

Okay. and then the are these claims made during 5, 10 k. Submission or after device clearance.

Michelle Lott, RAC: It usually happens it can happen both ways, you know. The best way is that you submit your labeling and any claims Michelle Lott, RAC: in your 510 K. With the data, and then, when your 510 K. Is cleared, you know those claims are already validated by the FDA, or, you know, reviewed in some way, and that you will not get in trouble for them later, because not only are they substantiated, but then they are Michelle Lott, RAC: we're, you know, reviewed. And and so you shouldn't have that issue of like, okay, I make a claim later. And even if I substantiate it. Michelle Lott, RAC: you know the FDA may or may not have a problem with it, because they they haven't seen it. And have I now implied something that I wasn't aware of after the fact.

Interesting. Is there a required? 2253 form submission for devices, as we see for drugs? I'm not familiar with that form.

Michelle Lott, RAC: I'm not familiar with that form either.

I I assume that it's a promotional form.

Michelle Lott, RAC: And and devices there. Michelle Lott, RAC: there is, or or was once, a specific form for indications for, yeah, your indications for use statement Michelle Lott, RAC: where you had to describe. Michelle Lott, RAC: You know that whole thing, and and it was and including Otc. A prescription. But now I believe that form is generated by by Eastar like. It's not something that you have to create outside of the Eastar format.

Okay, I love this question, does the FDA Randomly review labeling materials? Or is there a standard process? And all manufacturers are getting checked.

Michelle Lott, RAC: It's it's risk based. As I mentioned, it could be something that came to their attention. Maybe via adverse event or a recall. Michelle Lott, RAC: or like. We see some kind of product that is actually Michelle Lott, RAC: regulated by FDA, but is got some popular consumer. Michelle Lott, RAC: applications where the FDA feels like, because they are the that these types of devices are being mark marketed direct to consumers, that there's not enough oversight. So there could be, you know, something Michelle Lott, RAC: political or risk based, you know, involved around what they, what they look at and why it could come up.

Michelle Lott, RAC: and your competitors could even turn you into the FDA as saying that, hey? They have unsubstantiated claims, or you know, this intended use is is new or novel.

One of the things that I came across when I was researching this topic was the idea that if you're awaiting your 5, 10 k. You cannot start pre selling the product. And so what this question asks is, if we have an irb approval for an investigational device, can we promote the device for research purposes only, not for commercial resale.

Michelle Lott, RAC: That's a good question. I am not that familiar with the the marketing requirements around Irbs and Ides. Michelle Lott, RAC: but I don't believe your Irb. Michelle Lott, RAC: cause that. That seems like that. That would be around recruitment. Michelle Lott, RAC: and I would think that Michelle Lott, RAC: that would be that that would not be a.

Right.

Michelle Lott, RAC: Yeah.

That wouldn't be allowed.

Michelle Lott, RAC: Maybe somebody can put that in.

Through that.

Michelle Lott, RAC: If you, if you know Michelle Lott, RAC: by herbies and and marketing.

Right. I think the main thing is is that as long as they're not selling the product in advance of approval. that it's okay to talk about it. That's my understanding.

Michelle Lott, RAC: You can't. You can't sell it, but and you can't even take orders for it.

Right? Exactly. well, this is sort of, and a general question. But what are the most common pitfalls companies face when making medical device claims. and how can they be avoided? That's kind of broad. But what what are the most common things that companies get dinged for from the FDA? Would you say.

Michelle Lott, RAC: Well, you know, I I think that once a product gets clearance, particularly if you did not have those claims and wording that you want for your advertising and marketing in your 5, 10 K. Michelle Lott, RAC: You know, you're a marketer, Shawn, you know, you guys get super creative with like, we Michelle Lott, RAC: like even just put in the word neat or patient like. So I see that marketing people kind of get carried away and step outside of their balance. Michelle Lott, RAC: and that those things don't go to regulatory to review or marketing thinks, hey? My social media is outside the scope of, you know, something that's regulated.

Michelle Lott, RAC: or I don't have a responsibility. If Michelle Lott, RAC: Kim Kardashian says that this helps her butt fat like, you know. Michelle Lott, RAC: there's Michelle Lott, RAC: it's just it could just be a slippery and a slippery slope, with marketing language and marketing personalities into and and with without that oversight of their regulatory team.

Which leads into this. Really, it says, while this this may be hard to answer. what are your thoughts on the sufficient level of evidence for a claim related to patient comfort. increased confidence in clinical decision making things seem to fall into that marketing language category.

Michelle Lott, RAC: Yeah, you know, I would think that the 1st the patient comfort could be Michelle Lott, RAC: maybe substantiated, or both of them could maybe be substantiated by some human factors, study or survey, or or something along that that line. Michelle Lott, RAC: I think that that Michelle Lott, RAC: wording like that is a little bit of a less of a slippery slope Michelle Lott, RAC: like you're Michelle Lott, RAC: you're making a claim about preference, but it but you're not. You're not going down that path of Michelle Lott, RAC: better than or Michelle Lott, RAC: or Michelle Lott, RAC: or putting patient comfort in, or with other words that change

Michelle Lott, RAC: the intended use or technology.

I understand. Okay. so it looks like we don't have any more questions right now. and we're about out of time. Anyhow, I would just like to remind everybody to please. Please please complete the survey which is going to pop up when we close the window here to go ahead and register for Michelle's courses, either through wraps or her free course the Med Tech Startup School, and it, as always, subscribe to medtech leading voice, and if you have any questions, feel feel free to email me directly. And I'll be happy to

direct your question where it needs to go. Hope everybody has a great day. Thank you so much for your time and participation.

Michelle Lott, RAC: 2 weeks. Michelle Lott, RAC: Yep, thanks for your time. Michelle Lott, RAC: Bye.

Aye.