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[Music] hello everybody and welcome to the final session of the first day of the green light guru true quality virtual summit the three-day event designed to provide you actionable takeaways you can implement in your own company to innovate faster stay ahead of regulatory change and use quality as a strategic asset to grow your device business this session is on best practices for preparing and conducting pre-submission meetings my name is nick tittman vp marketing here at greenlight guru and i will be your moderator for today's event we've got a really special session scheduled for you today i know our speaker isabella schmidt is really looking forward to covering conducting usa missions with efficiency and effectively so before we dive too deep into today's presentation and introduce our speaker and her company proxima clinical research i'm going to touch on a few housekeeping items real quick first the session is going to run for about 45 minutes in total and will include a q a session at the end where isabella has been kind enough to answer all of your questions so i encourage you to submit your questions throughout the presentation as they come up in the box on the right hand side and we will get to as many of them as time permits uh just for your information this entire session will be recorded and you can download the slides at any time right from the window that you are on right now um this is our last session for the day like i mentioned so be sure to tune in for day two tomorrow at 9 a.m eastern standard time if you're interested in learning how to implement and maintain an audit-ready qms leveraging technology i encourage you to make sure that you're registered for the first session tomorrow and use your unique link to tune in all right i'd like to first share a couple words about green light guru and why we put on this free virtual summit if you've been to one of our training sessions before then you know that we put on these because improving the quality of life is our mission here at green light guru likely a similar mission as many of you at today's summit anything we can do as an organization that helps device makers bring safer life-changing devices to market quicker with less risk aligns with that mission we're constantly looking for ways to continue to fulfill that mission whether it's through hosting free events and training sessions like these through partnering with world-class medical device consultants like proxima research or through our award-winning medical device qms software if you'd like to learn more about why medical device companies from across across the globe are moving from paper-based and general purpose quality management systems and adopting our purpose-built medical device quality management software i encourage you to head on over to www.greenlight.guru after today's presentation and schedule your free personalized one-on-one demo all right now on to the bulk of today's presentation let me give you a proper introduction to your presenter today isabella schmidt isabella is a rac certified regulatory affairs consultant at proxima clinical research a contract research organization that serves the emerging drug and medical device industries isabella works with various medical device and drug products from small companies at the earliest stages of development to large publicly traded companies at the latest stages of development as well she serves as a mentor and judge for multiple accelerators and advises on pitches value props and regulatory for well over 100 companies so without further ado let me hand it over to your presenter for today isabella take it away thanks nick all right so um today's session is going to be on q subs and primarily focused on preserves and um and a couple of other types of q subs information meetings and um breakthrough device designations which are the most common types of q subs so we'll start off with what is a q sub so most people know of q subs by calling them presups um but q subs can run the gamut from a different a few different types of uh of engagements with fda so there are a way to interact with the fda all of them are you'll get a q number followed by six digits for every q sub and all subsequent interactions will follow that q number so if you're familiar with ides or inds it's much similar to that you don't want to have the same topic covered multiple times in any q sub so that's within reason um you know if you get feedback from the fda on you know say an animal study and then you want to have a subsequent discussion about that animal study with fda at a later time you can have another discussion but you don't want to have you know 10 q subs on your animal study so that's why they want you to do another thing which is outline the expected submissions if possible so for expected submissions you might think of um for a 510k you may have one type of pre-sub for pma you may have two or three and for genovas you may have two or three as well and that's because with de novos and pmas you have a bit more evidence generation that you need to discuss with the fda whereas 510 case in a lot of cases are a bit simpler because you have a predicate that you can sort of mimic once you submit a q sub you can't withdraw the q sub once you get feedback from fda so that so whenever you submit a qsub you want to be careful to make sure that whatever you're presenting to fda and once you get feedback from them that you're putting your best foot forward you don't want to um submit something that you've that sort of half-baked idea you want to really go forward with something that you're ready to present to the fda so if you're not ready to present it to the fda then you shouldn't engage in a q sub when you get accused of your original submission we'll start with your q number um and so you'll get that q number with six digits after it then every supplement is what they call it will be the subsequent q submissions that you submit to that q number after that so a q number will be associated with your device so if you do enough a new supplement which is a new uh request for feedback or another meeting from fda that'll get an s so you'll have your q and then six numbers and then it'll have s 001 after it amendments are another type of thing that you may submit to the fda and these are not really requests for feedback but they're um things like meeting minutes or slides that you might send to the fda and these will get an a number and a01802 for all subsequent submissions so there are various types of qsubs as i mentioned the most common of which being pre-submission meetings and then you have your informational meetings um study risk determinations submission issue requests and breakthrough device designations um so q subs so pre-sub sorry are by far the most common as i mentioned um informational meetings or problem and breakthrough device designations are probably the second most common types of meetings um the breakthrough device designations obviously being for those devices that would qualify for breakthrough and informational meetings are you know higher level meetings and pre-submission meetings you don't necessarily request specific feedback from fda study risk determinations and submission issue requests are um you know very specific to certain issues um and we'll get into that a little bit later the general contents of every q sub um regardless of the type is you'll have a cover letter and within that cover letter you'll have your company name your address the contact person and information should fda need to contact that person usually they will to you know schedule the meeting or send the feedback um you'll have your q sub type so is it a presub is it an informational meeting and then you'll have your meaning and feedback details so do you want to have a meeting with fda are you just looking for written feedback if you want to have a meeting what type of meeting do you want to have and obviously you need to give them you know the purpose of the meeting or the feedback and a description of your device because if you don't give them a description of your device how are they going to know what to comment on and obviously you know what your device is going to be used for um regulatory history what they're looking for here is if you've engaged with them in any type of qsup before um or if you have you know a marketing application in another region for meeting details you want to lay out an agenda if you're having a meeting and so the agenda for the meetings can vary depending on the type of meeting it is for informational meetings your presentation might be a bit longer for precepts that may be a bit shorter because you really want to spend a lot of time discussing the questions that you ask fda and their feedback and then you want to also give them the type of feedback that you want from them um so for meetings you'll suggest three times that you'll you may have for the meeting um you'll tell them your planned attendees and you'll give them um your you know audio visual requirements so are you gonna need you know a phone line a webex if you're doing it in person well you need a projector internet access you'll have to request that a few days prior because um fda is they need to give you permission to get access to their internet and they won't allow you to you know use usbs on any of their devices or anything so um if you need those types of things you'll need to let them know a bit earlier um and you want to suggest three like i mentioned three days and times um and i'll get to the how you suggest those in a minute um it'll be based upon when you submit your package and the number of days after that so getting into a pre-sub so pre-subs are a section of q subs and they are the way to obtain feedback from fda on specific questions for a future intended submission um so if you want to submit a 510k a pma or genova in the future you may have a presup to get information from fda specifically on your testing plan or your regulatory pathway if you choose to not have a submission in the future you know having a precept they're not going to force your hand and say you had a precept you must have a 510k or a pma in the future but usually you would submit a presup if you're planning on having some type of marketing application in the future it's a way for fda to give you a written response they will give you a written response with any type of presup and then if you request a meeting you can have a meeting with fda either via teleconference or in person um usually i don't ever really only request written responses um because fda provides you a written response regardless of whether you have a meeting or not so you're gonna get some sort of written information from them and if the written information is sufficient then you can cancel the meeting if you choose not to have it so there are a few questions that people ask um about precepts and the main question i guess is why would someone want to have a precept so pre-subs will improve the quality of your subsequent application because it becomes an interactive review process with fda so um fda is more transparent with you with what they want to see and you're more transparent with fda about what you're going to show them and then that transparency allows the review process of your marketing application to be smoother and the timelines to be a bit shorter also pre-subs are free so uh you know other than maybe a consultant's cost but um but from fda standpoint they're free so it's a way to get free feedback from the fda to ultimately have a more successful application in the future so there are some other questions with q subs that a lot of companies will ask me um and you know they're am i too early what topics can i discuss do i need to presup can i just email fda my questions where does the precept occur so the first question is do i need a presub um you don't need a preset they're not required but they are a really good idea there are very few cases in which i would suggest not having a preset um that being maybe you're an identical device so you're not just a me too 510k but you are the same device as another device that's out there um short of that it's probably a good idea to have a pre-sub no matter what um there are you know in the past there was maybe a more adversarial relationship between fda and companies so some legacy advice that people give sometimes is oh will you have a 510k i wouldn't worry about doing a presup um generally i i would not agree with that um it's always good to get some feedback um from fda even if it's just on how you present um your your your information in your futures application am i too early so you're not too early unless you are which means that um you need to be ready to present whatever information you're giving to the fda so and you need to be ready to defend that so if you're going to ask them for example about your regulatory pathway which may be one of the earliest types of precepts that you can have you'll need to be able to defend what you suggest your regulatory pathway is so if you suggest your regulatory pathway is 510k you'll need to be able to find an adequate predicate and justify why that predicate is adequate if you're not ready to do that you shouldn't go to the fda until you are because whatever you present to them if they come back and push back on you you need to be able to defend that uh the topics you can discuss in pre-sub are variable um and obviously within regulatory reason you can discuss regulatory pathways with them animal studies bench testing and clinical studies so things that you may want to discuss with a regulatory pathway are um if you don't have a suitable predicate device because you're a novel device you may want to discuss um justification for why you think you're a de novo and you don't need a pma or maybe you want a pma and you want to justify why you should get a pma animal studies you may want to discuss the appropriateness of your animal model the sample size of your animal model bench testing you may want to discuss sample size and power analysis if you're using test methods that are unusual and maybe you're not using standards that are out there you might want to discuss that with the fda and you'll want to justify any testing that you've removed you know from a scientific standpoint so just because there's something that's typically done for testing that doesn't mean that you always have to follow what past precedent was you can go forward to fda and suggest a better route clinical studies are obviously something that everybody wants to discuss with fda because they are your biggest cost driver um and so you really want to discuss if you're doing clinicals your end points your size make sure that you're gathering the right information for that really expensive clinical study and a lot of folks like to do studies outside of the us and you want to make sure that whatever data you're gathering from outside the u.s is sufficient for a future marketing application because not all studies are created equal and not everything outside the us is necessarily applicable to the us the pre-sub can occur obviously as i mentioned in writing so you just get written feedback from the fda again i wouldn't recommend going that route it's always a good idea to have a meeting um and if you don't want to have the meeting after you get the written feedback you can always cancel the meeting you can have a teleconference with fda or you can have it in person there are some benefits both to teleconference and in person so teleconferences are sometimes uh scheduled quicker so that's that's that's because the fda doesn't have to worry about conference room space um and so it's easier for them to get everyone um in the meeting the the other thing is teleconferences are a bit less expensive because you don't incur those travel costs however teleconferences don't afford you the ability to meet the fda in person so there's not that face-to-face interaction there's not that body language there and if you want to show them your device you can't really do that with a teleconference um and there is a strategic thing um with the fda when you go there in person if you ask them a question that they weren't expecting if you're in a teleconference they can put you on hold and have a discussion amongst themselves to figure out how they answer that question if you're in person they can't really put you on hold because you're in the room there with them and so it's you know someone's going to answer that question and maybe the entire group doesn't agree with that but someone's going to lead it and that's going to be the feedback that you've gotten and so sometimes it's strategic in order to have a really open discussion to be in person uh the the decision that i would make whether i did a teleconference or in person was how critical was the discussion that i'm having so if it's not a really critical discussion a teleconference is usually sufficient if it's a really critical discussion an in-person meeting is probably your best option and then people ask me if they can just email their questions to fda now you can email fda questions um but usually these questions are pretty general they don't require a lot of research on the fda side high level questions they'll answer they're very happy to do so but if you ask them a very specific question about your device they'll need the context to answer that question and so they'll tell you that they don't have enough information and they'll probably suggest that you file accuse them and again when you ask questions even if if they get more specific um they will go and ask uh the rest of their review team before they provide an answer um because again they want to provide a uniform front so even if they again if they're willing to answer your question they usually say oh i'll get back to you i need to talk to some other people and so that gets into the context the context comes from your briefing packet so whatever is in your briefing pack it needs to be sufficient to answer whatever questions you're going to ask so you'll obviously need to give them some information about your device the principles operation of it the key components of it what is your device intended to do who is the patient population that you're intending to treat or diagnose and then if you're going to ask them about testing you'll need to get them information on your non-clinical and clinical testing plans sufficient to be able to answer the questions that you're asking so questions are what really drives your meeting and so there are kind of two ways to figure out what you want your questions to be you may have some pressing questions and then that drives your meeting packet um but you may also start putting together a meeting packet and then come up with questions that you didn't realize you had so it's sort of a chicken and a kind of situation the packet can drive the questions and the questions need to drive the packet so whatever questions you ultimately have you need to provide enough context for fda to answer those questions when you formulate your questions you want to not leave the questions very general generally you want to be specific and you want to make leading questions for fda so like the opposite of what they would tell you in a courtroom you want to do that with your questions for fda so you'll want to maybe reference guidances standards regulations to put forth an argument in your question as to why the fda should agree with you so some questions here um these are some examples of questions for regulatory strategy so as you can see um in the question that's sort of that brownish pink color um it says given that there is not a currently marketed device that can serve as a predicate under 510k pathway does fda agree that a genova request is appropriate now um you probably would in your packet have a little bit more context around this because de novo requests uh have to do with your risk assessment too but um as you can see the beginning of the sentence is the beginning of this question is very leading um the fda to agree with what you want them to agree with and so you want to do that with all of your questions i'm not going to read every single question on this slide but you have them as examples um for example you may ask some software questions uh usually software questions will go along with the level of concern um so when you formulate this question you may want to say you know given that uh the device will not result in a critical injury or death does fda agree that this is a minor level of concern that might be exactly what this question says here but um that's the type of question that you want to ask fda about software and again you want to make sure that those questions are leading animal studies you can ask them questions so things like suppose you went to the fda at one point and you proposed an animal study and they came back and told you that they didn't think that study was sufficient for moving towards clinical trials so then you might go back revise that study and have a supplement meeting with fda within that supplement meeting you would ask a question you know i've revised animal study does fda concur that they revise animal study and the animal plan numbers whatever it might be um is potential to uh show that there's you know the safety for initiating a clinical trial and obviously again everybody you know if you're doing a clinical study you definitely want to meet with the fda about that clinical study because it is expensive and time consuming um so you want to make sure that what we typically do in a pre-sub is we'll put forth at least a synopsis um if you have a full protocol that's always better because then they can comment on your full protocol before you submit an ide if you're a significant risk device if you're a non-significant risk device um you still probably want fda to vet your protocol so you may ask some questions about your patient population your study size your endpoints and you can base these off of past precedent or science science and medicine um and then again if you're going ous you want to make sure that whatever data you're generating is either applicable to a future marketing application or sufficient to opening an ide presump timelines um they can vary but generally speaking fda tries to stick within a certain time frame so the first step is you'll submit your packet to the fda um within 15 days they'll do an acceptance review and reach out to you to schedule uh meeting dates so you'll propose three meeting dates with them um and they'll come back to you and say that either one of those days and times works or they'll suggest another date to you within 30 days you'll have to have the meeting scheduled um five days prior to the meeting they'll send you written feedback and that written feedback will really guide how you address your meeting i'll get which i'll get into in a minute um and then the meeting hell is held between 60 and 90 days after you submit that packet to the fda um usually what i try to do is get on the lower end of that particularly with teleconferences and the meeting is usually granted within the time window that i suggest with in-person meetings i try to be a little bit more lenient in the timeline again i usually get the meeting dates that i suggest or within you know close to that window but sometimes if there's not enough availability uh the timelines can be extended after you have the meeting 15 days post you are required to submit meeting minutes to the fda which they will then review and provide you you know their their redline version usually and a final version and you either accept those or you can say that you disagree um and then 15 days after whether you agree or disagree the meeting minutes will be finalized if you disagree that will just be noted so how to prepare before the meeting so this is where it gets into a bit more of the strategic items too um with regards to the actual meeting in and of itself so you want to again provide several options for meeting dates try to get it as you know in a short as short of review timeline as possible that the fda will agree with and then you'll confirm the meeting details with your reviewer um rpm here is regulatory project manager which is sometimes what um people on the fda side are called uh you'll set up a phone line for a teleconference if you're having a teleconference um and you know obviously you'll understand the meeting information in person um from your regulatory project manager if you're having a in-person meeting and then you'll confirm your attendees and agenda with your uh reviewer uh prior to the meeting then you'll prepare a presentation so within that presentation you'll really want to identify the topics that you want to target and you need to send that that presentation to fda within two days before the meeting i'm usually just via email a pdf is fine so getting into some of the nitty-gritty about the meetings um you have to remember that these meetings are an hour long um unless you request extra time and so you really want to utilize that hour to its fullest extent so typically you don't want to go into a lot of detail on your device because you want to assume that the fda has read and understood your briefing packet and you can usually tell what they have by the questions that they ask if it seems like based upon the feedback that you got that they don't then you may want to spend a little time on the forefront explaining what your device actually is um to clarify any misconception that they may have which can then change the conversation that you have with them um sometimes if you change the conversation too much um they'll ask you to submit another supplement to hash out some of those details but they'll try to be as helpful as they can within that hour um so but generally speaking you don't want to go into too much detail um in the presentation quote unquote format where you're talking about your device and your company because you really want to allow the time for the discussion so the discussion that you have with fda will be based upon the feedback that you got and the questions that you asked fda usually respond to your questions and they typically give you additional um information that you didn't ask about and so you'll read through that feedback and you'll prepare your presentation based on that feedback you don't have to go in the order that the feedback was given to you so if your first question isn't that important to you but maybe your fifth question is incredibly important to you then you can move your fifth question to the first topic of discussion because you want to make sure that you discuss the most important things in this meeting so you can eliminate questions that you don't need any additional clarification on in fact fda encourages you to do this um just let them know the beginning of the meeting that you're not going to be addressing those questions you also because you only have one hour you want to be strategic with the people that you invite to this meeting so you don't want to invite a whole bunch of people especially people who may be very vocal or opinionated who want to talk a lot so be strategic in both assessing the people that you invite to talk to specific topics do they have something to contribute to this meeting um usually you'll want you know a clinical medical person there if you're discussing clinical topics if you're getting into the nitty-gritty of bench testing or design you'll need your engineers there you usually want someone from regulatory um and then obviously you know executive management will be there to to hear what's going on in the meeting as necessary especially for smaller companies and then you may want to have someone additional there whose sole purpose is just to take notes because you will have to provide those meeting minutes to fda and you want someone who can get the most out of the meeting as far as being scribed um so that you can then translate those notes into the format that the fda requests at the end of the meeting you'll summarize all of your action items um with fda uh so this is typically i'm going to send you slot that's on my sorry slice i'm going to send you the meeting minutes within 15 days um usually they like to see microsoft word version of the meeting minutes because that's easier for them to edit you send that through email uh the rest of the minutes you know the formal meeting minutes have to go to the document control center still clarify items like that up with the fda at the end of the meeting um you really want to consider a few things to not frustrate the fda too so you don't want to treat them like a consultant they're here to ask you know specific pointed questions that you've provided information to them for um and you know anything that you hear in a pre-sub meeting is not necessarily saying hey you're gonna get cleared or approved it's to help you in achieving that goal in the future um and of course you don't want to send you know last-minute questions to the fda because they spent a lot of time preparing for this pre-sub as it is um moving on to another type of q sub we'll go into informational meetings briefly so informational meetings are um really a higher level meeting you don't really expect feedback from fda although you usually get feedback from fda but it's less formal feedback you won't get a written response from them um it'll just be sort of a meeting where they're asking you questions and then you're free to ask some questions so it's more of a fluid discussion um you may have a bit longer of a presentation in this meeting because you are essentially introducing your company and your device to fda that briefing packet will typically contain things like a device description uh maybe an overview of the testing that you've done a brief overview of the testing that you've done thus far where you think your regulatory pathway lies and so they'll give you some feedback on things that they may have considerate some considerations that they may have in the future or you know they'll ask you questions about your device and you can interpret that to move forward with you know a subsequent presuppose the informational meetings are also a catch-all for other types of meetings that may occur with fda that that don't really fall into another q sub um so some examples here are you know study design for a non-significant risk study one that may not be intended for a marketing submission but you just want fda's feedback on it and so they may give you feedback in these instances that would not normally be appropriate for a precept study risk determination i'll go through these pretty quickly so study risk determination really has to do with whether you're a non-significant risk device or a significant risk device and you know non-significant risk device usually uh are approved by irbs um where a significant risk device required to submit an ide to fda and so you can go to fda to get a study risk determination if fda gives you a study risk determination say that your non-significant risk device um they are sort of the final arbiter of that so the irbs will have to abide by that with fda if they say your significant risk device then the irbs will have to abide by that so it's just a way if you're sort of a borderline case to get fda's determination to not hold up the process with irbs because um if you go to one irb and they say you're non-significant risk but then you have another irb that says you are significant risk then you have to inform the irb that said you're non-significant risk that another irb said you are a significant risk and then you have to address this within i think five days with um fda and so that sort of mitigates the risks the study risk determination for those borderline cases submission issue requests these are specific to after you've submitted a marketing application such as um or an ide um such as so marketing applications would be 510k pma de novo um and there are some issues you know fda requests additional information you can have a meeting to quickly resolve those issues with fda so you for those briefing packets they're a little bit different you'll have specific questions and your proposed plans and maybe a protocol to address any of the specific issues that fda brought up um breakthrough device designations are one that are is very interesting to most companies um i can't tell you how many companies have asked me if they have a breakthrough device um and so things to consider when you're thinking about whether or not you have a breakthrough device you want to consider their criterion first of all so is the condition that you're treating life-threatening or irreversibly debilitating and that is an important point because fda is very focused on the indication statement for breakthrough device designations so you want to make sure that your indication is actually life-threatening or irreversibly debilitating um and then is the device treating or diagnosing um sometimes so there was sort of a hiccup when they put together the language for the law that they left out prevention and so if you are strongly preventative of some life-threatening or irreversibly debilitating condition happening you may get held up with sort of a policy flag um that the fda says that you don't qualify because it's more prevention than treating or diagnosing that's not always the case um with breakthrough device designations um you probably won't find if you're a company but if you're a consultant you will find that the divisions each division has their own sort of take on breakthrough device designations and what qualifies for a breakthrough device and what's required of a breakthrough device and so some of them may hope be held up on this and other ones may not and then you want to consider does it provide a more effective option than standard of care this is another thing that may vary division to division more effective means different things to some of the divisions so some of the divisions consider more effective as and um you know they provide equal accuracy but remove remove a sort of um adverse issue that is that occurs with one type of device whereas other divisions want it to strictly be like a more accurate device so when you're thinking about more effective you want to compare it to the standard of care and you want to make sure that you have a realistic expectation of technical success and that can be shown through literature or preliminary data and preliminary data varies again division division um and device to device so what they may expect of you uh as preliminary data isn't clear cut in all cases so sometimes they request clinical data if they feel that you know any other type of data is insufficient for showing a reasonable expectation of success i can tell you that sometimes the policy people and the division people don't agree on what is required for that but you you know can get a good feel um for what may be required based upon the types of claims you're making again with your indication statement being really important um and then you need to consider that again the definitions of life-threatening and irreversible debilitating um life-threatening means that someone is going to die if this is not treated or diagnosed irreversibly debilitating means that you have an impact on day to day and then if you don't treat this it'll progress to a more severe state that may have an impact on day to day so really consider when you're thinking about should i apply for breakthrough device do you meet these criteria then there's you know criterion two which you have to meet so criterion one we just discussed criterion two you have to meet one of you know four different options um usually if you need more than one of those you have a stronger chance because maybe fda doesn't agree with um 2a but they agree with 2c and so these consist of do you have a breakthrough technology so a breakthrough technology is a technology that is incredibly novel or is a novel use of the technology that already exists and again you would show this through literature or preliminary data um no cleared or approved alternatives exist so this means that they must have undergone pre-market review so if something else is out there in development maybe they already got a breakthrough device designation before you did that doesn't preclude you from getting a breakthrough device designation cleared or approved alternatives typically will reflect the current standard of care um and again we're looking at indication specifics so um the indication statement is incredibly important for breakthrough device designations i can't emphasize that enough my slides have run over the page my cup runneth over so um significant advantage so another one of significant advantages over cleared or approved alternatives so there are clear and improved alternatives but i have advantages over these and these advantages are usually along the lines of quality of life or safety meaning i'm reducing hospitalization i'm reducing some sort of adverse event that occurs um with the the current standard of care devices or i'm allowing patients to manage their own care and then the last one is benefit is the it is in the best interest of the patients um so this is sometimes confused as a catch-all and it really isn't um there are specific criterion that fall under this that guides how the fda views this um so you'll want to know if you know you're creating a public health benefit so maybe you have an ivd um that can you know i don't want to use the word prevent but that can diagnose um things earlier to prevent a widespread um uh you know contagion or something so you know a great covid diagnostic um and then or you might want to have one that um it considers that you have you avoid serious harm that may be with other therapies or if a patient is precluded from other therapies because of contraindications but they could have your therapy um that would fall under this best interest of the patient so here's one example of a breakthrough device designation this is not one i did because i usually don't like to like call my clients without their permission um but here is uh this this is one that was publicly announced um and it's a brain implant for patients with blindness so obviously that is severely um debilitating and so this mimics the perception of light through a miniature video camera worn by the patient that transmits a signal to their visual cortex which then would allow them to see um so obviously that would meet the breakthrough device criterion it is novel um and it does treat a life-threatening and universally debilitating condition and so the way they use this was they were able to engage with fda early um and often um and there was no real standard way to assess the benefits and risks of a device like this they weren't they didn't have past precedent and so having the breakthrough device designation allowed them to work with fda to establish those benefits and risks and that's the end where's nick insightful very very detailed um very actionable really great stuff and i think the audience would agree with the amount of questions that we have here always always a good sign lots of engagement so um we'll get rolling here i know we're we're slated to go till uh 5 20 5 25 eastern time we may go a couple minutes over with this in the last session of the day and just the uh amount of responses that we've had so far so without further ado we'll kick it off so christian asks does the eu have an equivalent process to fda q-subs and precepts no so what's interesting is with um the eu mdr being the way that it is currently um a lot of and you know that meaning uncertainty in the eu a lot of companies have been coming to the us to do pre-subs to figure out what may be required for them even in the eu to get you know a good you know regulatory body like fda to give them some input into what the fda would expect for their testing plan and then they're using that to guide their testing for the eu um for the most part with the eu um i could bite my tongue of this because there's still not much uh guidance out there yet but um for the most part for the eu um you probably save following mdd as much as you can right now so look at your standards that were there before um because the md isn't eliminated mdr is just adding to the mdd so figure out what did mdr add to the mdd um and it's usually along the lines of post market surveillance and clinical requirements and then you know move forward from there and again i i think it's a good idea to engage with the fda on that front come up with a really robust plan that you would think the fda would buy into engage with them in a pre-sub and then use that to help guide you in the eu awesome great great advice uh next one comes from dan so you've talked about bench and clinical testing any comments you would have on q sub questions on usability validation testing so usability validation is a really good topic to talk about in pre subs and i hate to always say this but division to division it always changes their feedback for everything um usability usually you want to consider your use risk analysis when you put forward whatever usability plan you're considering so the guidance states you know flat number of 15 users is what they recommend um but that's not always necessary and it's not always necessary to um you know have vaults i hate saying this but it's not always necessary to have multiple you know usability testing you don't always need to do you know three formative evaluations before summative evaluation if you're really complicated device of course but that would go into your use risk analysis so you want to look at your critical tasks what are the risks associated with those and come up with the useless ability plan surrounding that and go forward with to that with that to the fda um and i've seen them agree to you know less than that 15 um but you really want to have a good plan in place that you're really addressing all the potential critical critical risks associated with use and um and that the users are able to effectively use the device all righty then we got a two-part question coming up here maybe dispel a myth so kim asks if we can if we want to consult with the firm about market access and reimbursement pathway for our product it seems that it makes sense to do so before a pre-sub mission would you agree with that that's part one and then two it sounds like proxima only works on fda approval is that a true or a false statement well number one so question number one um it depends on what the intention of your precept is um i always think it's good to get reimbursement regulatory and clinical addressed as early as you possibly can together to consider them as sort of one sort of decision because they all affect your market access ultimately right um but if you're going to a pre-set up and say you're trying to figure out whether you're 510k or genova um it it may not be necessary for you to have you know a market access consultant comment on that unless of course your reimbursement changes for 510k versus de novo and then and you're a borderline case and then maybe you can change your labeling to get a genome and get a better um you know ultim better cpt code or whatever type of um i'm not a reimbursement expert i know enough to be dangerous but um definitely talk to a reimbursement consultant on that but um you don't need to have engage with your reimbursement consultants have an effective precept but if you want to talk about clinical it's probably a good idea you can also engage um payer you can request that payers um engage in a precept with you um and you know that that's a good idea depending on how worried you are about what your clinical requirements may be for payers um so if you think for regulatory approval you need you know 100 patients but payers are going to say you need 5 000 then maybe you don't want to bring them into that meeting um so consider what you think for regulatory approval is going to look like first and then maybe ask a reimbursement consultant what they think it would look like for payers before you engage them in you know before you bring pairs into the actual meeting but more for clinical i think that um engaging with reimbursement consultants early on is particularly good the second question no we don't just do fda um we do a lot of fda but we do eu submissions so ce marks um as well and some canadian submissions but canadian submissions are not to hate on canada but canadian submissions are pretty rare just because the market is small and so people usually want to go to the eu or the us first because of the market size and then australian submissions um they can usually get approval if you have eu approval so we don't do any asian submissions or anything like that yeah thank you for uh dispelling that myth uh we got a comment here i i just think this is good so it's this is from george zack who's one of our speakers with two two harbors consulting uh it's gonna be speaking with us here in the coming coming days on the virtual summit but he said not a question but not inviting opinionated uh people who talk a lot is some of the best and most humorous feedback i've ever heard that is great that's good yeah i think for expert advice um going on here we got a couple questions around this topic of recording meetings with fda um is it permitted is it common are you allowed to record those nope you are not allowed for them we'll try to get to one or two more here um next one is product classification separate from the pre-sub meeting if not how do i include questions that depend on product classification in one meeting so um there are two ways that you can kind of figure out what your product classification is you can do a 513 g which is different from a pre sub or you can talk about it in a preset 513 g i usually don't recommend those because it's essentially this is what your product classification is and then that's all they tell you whereas with the presub you can ask them product classification questions and then get information on testing as well so with product classification questions you would essentially put forth um here's my risk assessment say so i think and here's a product code that i found and here are other devices that are similar under that product code you know one or two of these things or i don't have a product code um so i think i might be a de novo because my risk isn't high enough to justify a pma say and you would put that in your packet and then you would ask fda you know based upon xyz you kind of do a short summary of what you've established in your packet and your question does fda agree with you know this product code um and you know being in class 2 and filing a 510k or genovo and they'll usually respond to that and they'll give you an answer now you want to remember that classifications are never final until your final market application so they'll give you feedback and a pre-sub but they can change their mind now they usually don't they try to stay consistent with their feedback but they can change their mind if there's some sort of public health thing that comes up after the fact um or some new scientific evidence that they learn about after the fact or you get a change in your review team um i have seen it where a change in the review team a company from a 510khz but that is not the common case i would say they usually are consistent with what they tell you all righty thank you and one one final question here to wrap up the first day the true quality virtual summit comes from robin uh if your device has received designation as a breakthrough device do you recommend a q sub meeting with fda to determine the appropriate submission approach uh or would you just submit the 510k addressing any feedback from fba that arose during breakthrough designation review so the feedback for the breakthrough designation typically is just specific to the breakthrough um so if you if you get feedback it may not be it might not have anything to do with your test being sometimes it will because they'll say your testing right now isn't sufficient to establish a reasonable expectation of success but a reasonable expectation of success is not the same thing as the valid scientific evidence needed to establish safety and effectiveness it's just your preliminary stage of that um so you should engage with fda after you get a breakthrough device designation in a presup or one of the other formats that are allowable with breakthrough device designations so you can do precepts but they're also um you know they'll discuss things through sprint discussions with you which are um you know inter interactive and iterative discussions um on a very specific topic so suppose you have a very specific question about your clinical study you'll go back and forth with fda on that specific question that's something that you get with breakthrough device designations that you don't with a standard type of device um and there's other things where they'll talk about your entire data plan with you with breakthrough device designations so but again you can do you know your standard presup as well which people do um i have clients who still do the standard presups um when you have a breakthrough device designation they try to get your pre-sub reviewed a bit quicker and obviously senior management is involved in all of those discussions with breakthrough devices um but they won't guarantee it as usual they don't really guarantee anything um but but they try i will say they try and some divisions again are better than others all righty we are at the the end of our day one um for the true quality virtual summit just an amazing presentation isabella thank you so much there's so many great comments coming in um just great presentation lots of practical advice really enjoyed it another excellent presentation well worth the late day here in europe uh so it sounds like you got got people staying up literally in europe yeah so if anybody has any questions that i didn't get to answer or you didn't ask because you were shy um you can send me an email or connect with me on linkedin and send me a message um and let me and just let me know that you saw this and ask me whatever questions you want awesome thank you there's plenty of questions uh left here obviously we'll be sending those to you as well um where can people find out more about proxima so our website is www.proximacro.com we also have a linkedin page and we usually try to be pretty active posting on linkedin so if you follow us on linkedin you'll find out information about us too awesome and then they got great stuff on there they are a great partner of ours here at green light guru be sure to go check them out all righty um um this is end of day one we look forward to seeing you all tomorrow nine a.m uh eastern time thank you all for attending today and thank you once again isabella for your time presentation really enjoyed it thanks for having me alrighty take care [Music] everyone [Music] you