NHLBI Small Biz Hangout: Medical Device Regulation Overview



good afternoon and welcome to our third NHLBI small biz hangout my name is Chris Osceola and I'm a regulatory specialist at the National Heart Lung and Blood Institute in the office of translational alliances and coordination I work with investigators in the cardiovascular pulmonary hematologic and sleep disorder space to help them understand the regulatory framework and processes that surround biomedical investigations and technology development in the United States these hangouts are an interactive way for me and my office to help provide this information today's hangout will focus on understanding how FDA classifies medical devices based on their potential risk profile and we'll also talk about how that classification impacts the FDA approach to regulating your release to the commercial market either as exempt from review subject to demonstration of substantial equivalence to predicate devices or through thorough evaluation of their safety and efficacy attributes in premarket application will pause at the end of each section of the presentation today to answer your questions we ask that you please pose questions that relate to the content of the presentation rather than questions that relate to your specific technology as we would likely need much more information about your innovation than should be provided at a public forum in order to answer your question I would like to remind our YouTube viewers that you can post questions to my office's Twitter handle at NHLBI underscore SBIR or by using the hashtag SBIR chat if you're participating through the Google+ platform you do have the option to post questions directly to the hangout page or you can also choose to submit them via Twitter if you're watching this video as an archived event and have questions about its content please at please reach out to either myself or today's presenter today's presenter is ms Lori Weber Huffman I'm very happy and excited to welcome her to our hangout today Lori is currently a maraca senior director at illumina alumina applies innovative technologies and revolutionary assays to the analysis of genetic variation and function the maracas subsidiary continues to provide full consulting services to in vitro diagnostic medical device and companion diagnostic development companies as well as fully supporting alumina projects prior to joining maracas in 2010 Laurie was the senior director of regulatory affairs at volcano corporation a cardiovascular diagnostic firm where she also served on the company's leadership team and assisted in taking the company public at volcano Laurie was responsible for global regulatory activities covering the areas of Japan Europe Canada the asia pacific and latin america her regulatory affairs and quality systems experience dates back to nineteen eighty-four she's worked with medical device and pharmaceutical companies such as volcano baxter healthcare and alza now a part of J&J as an independent regulatory and quality consultant she's worked with many other companies including Genentech Medtronic and the Sutter institute for medical research Laurie has earned her European regulatory affairs certification to the regulatory affairs professional society and is a California state and nationally licensed clinical laboratory scientist with the american society of clinical pathologist she earned her bachelor's degree with him in microbiology with a minor in chemistry from Northern Arizona University and a master's of business administration with marketing emphasis from california state university-sacramento and with that i would like to say thank you very much Laurie for joining us today and hand over the presentation hi everyone and thank you Chris and NHLBI for the warm welcome an opportunity to participate in this Google hangout today's agenda we're going to go over device classification at a relatively high level will move on to intended use statements and how that plays out in device classification from there we'll talk about some paths to market based upon those classifications the different types of submissions required and then device tools and requirements that you can use in the development of your device to meet those regulatory pathways so starting with device classification I start out this presentation with a link to an FDA site here it goes into classification in in detail a major factor that FDA uses to determine device classification is risk so a few your device that you're developing presents any new risks for a device that's currently on the market we've also known that to be called a predicate then that is something they'll take into consideration on the class that it'll be also whether your device is a tool or a treatment can impact the device whether it's a high risk or a low risk device on how it's used and then also where as an adjunct therapy to a diagnostic it's probably going to be a little lower risk because it's not as significant as a sole a treatment device for example another key factor in determining device class is intended use we will explore that a bit later in this presentation ideally I'd like to say at this point that it's really worth spending a lot of time crafting the language around your intended use as you'll see I'm coming up with your initial submission you like to be more general in your intended use and as you proceed through your development then get into more specific intended uses and subsequent submissions and here for example a general indication could be for example peripheral vasculature versus down the road you might list out specific vessels such as carotid vessels there are three types of classifications that FDA uses and they go from class one is the lowest risk up to class 3 which are the highest risk devices class 1 devices are not intended for use in supporting your sustaining life and they may or may not possess present potential unreasonable risk of illness or injury to patients that's a you know straight up definition out of you know the FDA guidance most other devices are going to be class 2 or 3 and I would suggest that most people are going to be working on class two devices initially I've made this little table here to help demonstrate devices that might be a moderate risk likely class 2 and then conversely devices that would fall into the high-risk category a likely class 3 most class 2 devices are going to have predicate saan the market already and if your device is going to provide information that's not a soul diagnostic but a piece of a puzzle you're likely at moderate moderate risk and going to be a class 2 device conversely to that on the right side you'll see if your test provides information that is so diagnostic it's telling whether your patient has a disease or not that's a higher higher risk scenario and likely a class 3 relative to misuse of your device if the misuse is a small chance of that happening or the misuse wouldn't create a serious situation again you're going to likely be a class 2 device conversely if there's a high chance of misuse and that misuse could lead to significant injuries you're likely going to be a class 3 device their devices that have been on the market for a very long time have a long history of safe use those have demonstrated to be at moderate risk you're likely going to be class 3 and finally the latest trend in medicine right now are personalized medicine and you might hear a lot about companion diagnostic so those devices where information is telling a physician which drug to use or not use or how much to use those currently are falling into the class three the high-risk categories this graphic here is another way again of showing that risk stratification how FDA is looking at these starting at the bottom with the least risky going towards the top with the most risky hopefully as you read through here you're starting to get a feel for how risk plays a factor in these classifications at the bottom we I listed some class 1 devices you know some basic imaging introducer stethoscope for example in the center some class 2 devices you'll see your ptca catheters because they're invasive you've got digital blood pressure monitors and respiratory monitors and then finally at the top some class 3 devices vascular grafts pacemakers etc and there's your companion diagnostics are there any questions on this information so far so I am looking at both our twitter feed and the Google+ page and at this point Lori we do not have any questions but i would like to remind our viewers that you can post questions at any point in time just type them onto the google hangout page or post them on twitter and we'll be sure to answer them either throughout the presentation or at the end thank you ok terrific so we'll move on to intended use section of our talk today so there's two definitions at FDA lays out here for intended use and a different one for indications in reality these two terms are used interchangeably if you're looking at labeling of devices out on the market right now sometimes you'll see two sections one called intended use one indications maybe you'll only see one called intended use or vice versa again it's not necessarily what you call the section of your labeling the point is the intent and the words that you're putting in there so the general purpose of the device and its function the disease or condition the diagnosis and the way in which this device is going to be used and that's the information that FDA is looking at as far as how your device classification is going to fall and how this plays into the risk of your device and then taking that a step further this is where I mentioned earlier to spend some time crafting your language for your intended use because it does impact the way FDA looks at your device and you can craft it to fit if you will into a desired classification if your initial intended use is somewhat general again my example with the blood vessels you just say vessel and leave it general like that again that's probably a lower risk classification if you become more specific in the next example where you're speaking of carotid arteries depending on where that's used in the clinical setting that could be considered high risk because it's an artery it's a carotid it potentially could fall into a class three but again this is where I'm hoping you can see the words you choose and your intended use can really drive that classification the statement that you use does have specific things you want to include you know the indications the clinical setting target population etc FDA has a nice how to craft your intended use on their website but again keeping it general is ideal for your initial applications another thing that gets easily overlooked is your marketing literature FDA will consider the way that your marketing and talking about your device as indications for example you could have your label that says I have a scalpel that's intended to cut tissue but then when you're out there talking about your device and marketing it you start talking about it's used for making incisions in the cornea an FDA will take that information in consideration and again you're starting to become more specific and perhaps end up in a higher risk situation again FDA does spend a lot of time on discussing this they've crafted this levels of specificity which is a qualitative ranking of proposed indications on this slide the topic is for diagnostic devices and they have this ranking listed here of you know for incremental elements that increase the specificity as you go down the list so initially if your indication is just talking about a physical parameter then you add in a target population then you add in your clinical use and then ultimately the most specific scenario where you're talking about clinical outcomes in this case here's a similar scenario that FDA has regarding if your device is a therapeutic device again generally the most general scenario when you're just speaking of function and then you increase your specificity as you go down this list again with clinical outcome language leading to the highest specific indication you could have a lot was going on there so I tried to pull up some examples and from the existing products that are on the market to kind of show you how the words you choose and this general versus specific language can play out in the real world with devices these three examples I've listed here are falling into the diagnostic scenario that we had two slides ago so here we have the first one with the vesic some catheter we have specifically use is for introduction a bit of devices and then we have the anukul anatomical site being very specific renal arteries the next device the preview catheter it's of a similar specificity kind moderate you're talking about the anatomical location the peripheral vasculature you're talking about assessing discrete regions but it's not specifying specific vessels so it's a little more general then if you were to actually list the vessel there and then it's also using the word adjunct which again is a nice word to use to keep it at a lower risk category and in it more general scenario finally the last example with the milk or respiratory monitor um we've added patient population to this intended use that the prior to didn't um you'll see midway through the text here where it does talk about adult pediatric neonatal patients as well as well or poorly perfused um patients so again just some examples of general versus more specific language you can use in crafting your indications for use and intended use okay any questions or comments on this section so yes Laurie there there actually is a question and the question relates to a comment you made earlier in your presentation can you please explain what is a 510 K de novo yes I can I'll be someone high level here although types of submissions are definitely conducive to a whole nother hang out lots to talk there a 510 K de novo scenario is where there is not a predicate currently on the market but you feel that the risk is moderate and so the whole 510 K paradigm requires that there be a predicate and you're showing substantial equivalence but since there isn't then it's out of that paradigm they've created this de novo process that would allow you to get clearance as a moderate device 510 K without a predicate and usually the result of that type of situation will be what they call a special controls document which is a good segue for later in my talk here we'll talk a little bit about that but it is a way to get on the market as a moderate risk class to device well excellent thank you for that very thorough answer let me check and see if we have any additional questions it appears at this point that we have no more additional questions so back to the presentation okay let me do that okay so path to market so once you know your classification of device then you wonder what type of submission is going to be necessary we have that good question on de novo that is definitely one of the options so let's start at the beginning if you have a class one device you have no submission requirement and there are also another set of devices called class to exempt this link here to the access data site is a listing of all class two devices that are exempt and I'll show you some examples shortly here that will help you see where FDA can specifically tell you your class of device and whether you're exempt or not most devices are going to be class too like I said that do require a premarket notification also known as the 510 K this guidance here alternate approaches to demonstrating substantial equivalence in premarket notification that guidance document lists three types of submissions for the x 10 k a traditional and abbreviated and a special again i won't go into detail in this hangout about those three types of submissions on it mostly has to do with content and then FDA's review timeline requirements they have just hot off the press a few months ago issued a new guidance document that's replacing a much older one called evaluating substantial equivalence um this new guidance document it specifies information that should be included in submissions it does go into explanation of one clinical data meet may be required which is an improvement from the earlier guidance and there is a decision-making flow chart to help you walk through that application process it intentionally does not go into the details about the abbreviated or special 510 k roots and that's because in the near future we are expecting FDA to publish two new guidance documents that specifically address the abbreviated and special process although in the meantime you can go to this first guidance the alternate approaches guidance that does go into some detail on those different types of submissions and then finally for your class three devices you are going to have to follow the pre-market approval application process the PNA the dreaded term PMA that people hear about again if you're a class three device I didn't list the de novo in here but we did have to talk about it shortly and that would be for a class to moderate risk device in that number two section there okay so as promised here's an example of how some of this plays out in reality so if you have a stethoscope and you have determined that your regulation this 870 dot 1875 it says right here on this page that your submission type is 510 K exempt and that it is a class one device um do read the notes when you are going through this with your device um there are limitations of exemptions that are listed here and again you can go and read those on your own if it applies to your specific device but um for the most part the key is your class one you're 510 K exempt here is an example of the class to device where it also is 510 K exempt and in this case you'll see in the notes that there is a reference to special controls devices and we'll talk about those controls shortly and again but that link will take you to a list of class 2 devices that are exempt from the premarket notification or 510 K process so now we're take a different approach on looking at information if you go back to your regulation number that you know and in this case we're showing 8 7 8 40 40 and again the classification is listed right on this page that I have an outlined in red so surgical apparel it says it's a class 2 device with special controls for surgical gowns and masks but do you notice they also have listed class 1 general controls again for surgical peril but it's other than gowns and masks so here's a case where you have one regulation one type of device but there's two different classifications and two different requirements for submission that you can see here so any questions on that information before we move on to our development and tools for developing so yes Lori there actually are some questions although they do refer back to the prior information that you presented more so than the current okay section so the question is and it's sort of a two-part question I believe why would you use a specific intended youth statement if a general intended use statement can be used to cover all of the indications for use the example showed very detailed indicate indication such as well or poorly refused why would you go to the trouble of delineating all of that information okay great question great question um there's multiple reasons that you could choose to do that um one reason is your business goals and marketing goals what is your target market if you want to be able to market to specific physicians specific clinicians you might need to have that specific detail in your language in order to penetrate that market and get there and have it use there another reason is what if your competitors been FDA doesn't really like different they want you to be the same if you will to your predicate device to your device you're comparing to that's already on the market and so the more you can look the same the easier sell it is if you will when you're actually doing that submission a third factor that can come into play is the type of testing and data necessary if you are specific and call out a specific anatomical location it's highly likely some of your bench testing will need to incorporate models that use those anatomical locations or different types and that could be an advantage for you to like maybe a barrier to market entry of a competitor if you have gone to that trouble of doing that additional work on your bench studies as well as perhaps your clinical testing at the end of the day it does kind of come to a business decision I always recommend get your first clearance being general if you can just to get on the market and then future submissions you can play off of your own device as your predicate and start building on it then FDA has that learning that understanding and you can move forward more easily that way that's excellent can you also just just a little bit how your relationship with a reviewer or a review team might evolve over the life cycle of a medical device terrific yes good question um nowadays the environment is such that FDA they've always said as long as I've been in this you know come early come off and they want to hear hear from you and so they're really wrapping their arms around that now with much more clear guidelines on how to get through that process so before you do your initial submission you have a pre-submission with FDA and you'd be in front of them usually that initial reviewer who gets that assigned york resubmission package if you then subsequently do a 510 K they try to have that same reviewer and review team on that 510 K review team subsequent pre submissions as you go to your next phase again in the documentation you list your history numbers every pre-submission is given a cue number and obviously your 510 K has AK number so you include that information when you're doing subsequent pre submissions and 5 10 k's etc and they have that linked to the prior reviewers they do try to keep continuity across your device all the time it doesn't always happen um everything is in the record though so if your reviewer should switch they do have access to that prior information but um but that's how you start building that relationship before your first device ever hits on the FDA and then again it's a relationship with the same reviewer and team as you move forward to all your iterations of your device I love it that's great thanks so much that's all we have for questions right now so let's return to our scheduled hang out okay we'll keep hanging out okay so device class required and tools okay so we just talked about types of submissions according to your classification and regulation number and now we're going to get in to see how we're going to start building our development plans and actually developing the data that is going to be necessary to put into these various submission types so there's two types of controls I think we saw earlier slides there's general controls and special controls general controls apply to all medical devices and those are just basic provisions that FDA has it's their regulatory means to ensure that devices are safe and effective on the market special controls are device or device category specific and they are developed as automatic class 3 designation devices which again topic for another hangout and also we talked previously they come out also from the de novo process um and then one other little interesting thing to whet your appetite for future hangouts special controls does allow you to go through the abbreviated 510 K process and again we'll save that one for future the general controls are listed here they're on the FDA website again these are mechanisms FDA has to ensure devices are safe and effective on the market the only ones I'll specifically mention our device registration and listing even if you're a class one device you will be registering and listing your device on the FDA website so FDA has this ability to what is out on the market and then also the last one I'll mention our Good Manufacturing Practices also known as the q sr quality system regulation again all devices are matter to class have to follow those and again another topic for a future hang out our GNP s special controls like I said they're unlisted if you recall on that one page for that particular device it did say that there were special controls for it here I pulled one out as an example for ptca catheters here's the link for it just to show you and help you appreciate the detail of these controls documents are here are some of the elements off the table of contents of this specific guidance and you can see it goes from bio comp testing content and format of the test data it has specific performance testing requirements that it lists in the controls document it goes through animal testing clinical testing sterilization shelf like them labeling so they're very thorough and complete controls documents that pretty much can guide you through the development and testing of your device so that when you do get in front of the FDA you've got information that's going to meet their expectations I wanted to show you a little bit about biocompatibility again just to see how does this actually play out in what do I test my device where do I start the guidance or the standard that everyone's using an FDA recognizes for biocompatibility it's is a 109-93 and you'll see in this document that it first starts out by listing the nature of the body contact so here you see there's three methods of contact of a device one is surface contacting one is external communication and the one-hour implant devices inside of each of those are subcategories so with surface contacting you can be on the skin completely external it can be mucosal membranes such as you know your eye endotracheal you know etc wherever there's mucousy membranes and then breached or compromised services services where you've had cuts and abrasions and whatnot and etc I won't read these to you you can see that each body contact area has of categories inside of that the next step after your contact location and type then you're looking at duration how long is your vice in contact with this body part and here we have limited exposure it could be a single use or it could be multiple times up to 24 hours there's prolonged exposure which is 25 hours but less than 30 days and then the last one they consider permanent even if it's not permanent if it's more than 30 days it still has the same requirements as a you know purse a permanent device so then how does all this come together they have this wonderful table in the standard that kind of shows you then the testing that is required so let's pick a an intubation device let's say that on the left the category will say that that is a surface contacting device we know that it's mucosal because you're going in your esophagus so that would be the center this mucosal membrane and then the third column is your contact duration typically an intubation device let's say it's used in on you know in an ER will say it's less than 24 hours so it has limited exposure that would be your letter A and then if you read across then you have the testing that is required to demonstrate biocompatibility so you look where the exes are so for a surface device of mucosal membrane with limited contact less than 24 hours you're required to do cytotoxicity sensitization irritation of entry or in inter of cutaneous reactivity who um taking that same device but let's say it's it's greater than 30 days letter C you would have to do those same three tests but additionally you'd have to do subacute and subchronic toxicity as well as the genotoxicity so again this is just a wonderful table that kind of you threw your device biocompatibility requirements and the standard does define the test methods that are necessary for all these biological effects that are on the far right section and then any test lab that you're sending your device's out to if they're certified in this ISO testing they're certainly going to know on how to do this and how to write the reports that FDA is familiar with seeing and be acceptable for your submission so another source of information to help you in the development of your device and creating these tests information that needs to go inside your submission our standards and the biocompatibility standard is one that we just went over it at length at some length and there are two types of standards in FDA's I some are recognized consensus standards and then others are just consensus standards um the only difference is FJ recognizes some and not others um they are most times you have to purchase them they're usually a couple hundred dollars based standards are voluntary FDA does not require that you follow them however if you do follow a recognized standard and that's you know demonstrated in your submission in your reporting there's going to be you know FDA is not going to have any questions on the methods you used and what not it's it's pretty straightforward they just go straight to the data and whatnot if you haven't followed a recognized standard again that's fine you would just explain we use this these methods because and justify the rationale for the testing you did based on your particular device and its design some other examples that I've listed here that are extremely common electrical safety testing through the IEC document and then there's some radio frequency some RF testing again very commonly uses this BS en 55 11 um standards and there's just a plethora of standards out there and I'll show you in a minute how to find those um the the last source of information that can help you with developing your device testing RFD guidance documents um this link here again will give you just a whole laundry list of guidance documents available for various devices on the market or in development here's the search engine on that day website that will get you to the consensus standards those standards those voluntary standards at FDA recognizes drop-down menus it shows you all of them I so again IEC Amy etc what the most useful thing I'd recommend for you just starting out is you know your product classification we just went through that so you have a product code it's the three letter code ITX etc or perhaps you don't know that that you have your regulation number you can type it in this box in the center of the screen I'm not sure if you guys can see my mouse but um type that in there and then it will it will list out every FDA recognized consensus standard that's applicable to your device's regulation number or again if you know the code the product code you could put it there as well and voila here is an example of that so here I knew my regulation number was 89 to dot 1570 I maybe I knew my product code ITX either way you'll get the same page or it's it's a you know ultrasonic diagnostic you can search by that also and here's our list of recognized standards um there's 37 standards listed here that FDA recognizes again these are purchasable you are not required to follow this these are voluntary but again you can see that FDA has an expectation of this type of data in in the submission that you're going to be doing and then also what's nice on this page is it does list guidance documents so there is one guidance document specific to this regulation number 892 1570 and it's called information for manufacturers seeking marketing clearance of diagnostic ultrasound system introducers they're not short in title but again just that another great resource in development of your device and the type of information you'll need for your submission so finally we'll have some conclusions here from this talk so again we start high level the device classification its risk-based intended use and indications the words you choose definitely can influence that risk determination device class then determines the submission type whether it's a exempt or a 510 K or a premarket approval application all devices are going to follow general controls regardless of the device class that's just a basic expectation and there is many tools out there on your development path that can help you in designing the tests and information that you're going to put into your submission those are special controls there are that are available for specific devices and device categories there's consensus standards available and then again there's FDA specific guidelines that can be device specific as well as as generic so that is all I had to talk about but I'm happy to answer more questions I know that was a lot to take in yes it was but you did a wonderful job thank you so much luck um we actually do have a couple of questions so I good to start out by asking one that leads directly from what you were just the about and the question is are there standards or guidance documents or guidelines for all types of testing that FDA might want to see in a device submission there is not for everything out there unfortunately but but there is a lot out there so um again if you you know start with the consensus standards of voluntary standards you know what is out there that applies to your device again with this new found communicative FDA that we have and wanting to do these pre subs I highly recommend come up with your development plan we feel that these are the tests that are appropriate to demonstrate substantial equivalence you can be fairly high level on the types of tests and maybe the models your number of samples what you're going to compare to etc and submit it in a presa announced FDA this is what we're thinking this is why we feel this is appropriate based on our device design and our intended use and get their feedback and they will give you feedback on you know whether they feel it's sufficient or appropriate they might have suggestions on something different and remember FDA is not a consultant they will not consult or you know they will respond to questions you ask and give you feedback but they feel you're the expert it's your device you designed it so tell them what you think and why and they'll give you feedback great wonderful and a follow-on question to that one of our audience members wants to know is there a best time to approach the FDA with a medical diagnostic device pre-submission for instance before or after a prototype is made or even just in general should you target a few months before your submission or a year before your first products what sort of guidelines might you suggest to our audience members sure sure um if your device is very unique and new and novel I would suggest the earlier the better again treated as an education opportunity to FDA they they are interested in technology and what's happening out there so you could go with a fairly high level discussion with FDA and just give them your vision this is our new cool thing this is why this is how we think it'll impact it we have a three-step development process our first submission it's going to be this very general use and then our next one etc so that would be before you even come up with a prototype maybe it's when you just have the concept drawings and sketches if you're a more obvious Amy to device or something that's serving a market that's already served that may be a different way of doing it I would still go in be you know after prototype but before you've done any of your hardcore testing if you will if you're familiar with the qsr are you do it before your design freeze before your initial verification test just to talk with FDA your thoughts on verification testing on what you're thinking of doing just before you invest the time and money into that testing you want to make sure what you're doing is the best use of your time and money it'll result in information in your submission that old that'll carry through but definitely talk to them before you do testing that you think it's going to go in your submission wonderful and I actually have a follow-on question for that that I think our audience might want to hear an answer to and that is can you go to once you've had a pre-submission meeting with the Center for Devices can you go back to that same reviewer or review team for clarification or for a second pre-submission meeting about that same target technology yeah great question and absolutely they really encourage that every pre-submission again it'll get a cue number and the first two digits are year so this year you're getting q14 and then the other digits are consecutive they'll close that interaction out with minutes and they'll send you a note this is closed if you want clarifications or subsequent communication on it then you submit a supplement you use the same q number and then you just say s 001 supplement 1 and then you submit that and again it it ties all the documentation together it tries to keep the review team together and it just builds and that's what you would do these I've been involved in pre submissions that have gone on for years like three years and we're still we're passing we're out of our prototype phase you know now we're getting into you know our initial clinicals and so yeah that's how you do it by supplements you get there's no end in the number of supplements but you want your questioning at each supplement to be relevant and pretty specific so FDA's time is not wasted and it's fruitful and and you're getting valuable feedback to move you to the next development step wonderful thank you so we have another who have several more questions hopefully you're not in any rush mom our next question is how much supporting data is needed for a 510 K versus a PMA submission and what are sort of the basic timelines for those submissions both were putting you for submitting them but also for hearing feedback from the agency okay oh yes those are the hard questions and it's the first thing you should do is research for a 510 K research your predicate your devices that you want to compare to 510 case summaries are available on the FDA website and so look at those and see what testing they did and that will give you insight to the types of testing it will give you the end number like sample sizes etc um and remember with the 510 K you're just proving substantial equivalence that you're the same or no worse than this other device that's on the market when you're in the class three high risk the pre-market approval scenario you're having to actually demonstrate safety and efficacy so the amount of data is increased from a substantial equivalence the amount of increase I can't tell you that's very device specific again you'll be having lots of conversation with FDA to find out again what are those n numbers you know what's the burden of proof and the type of proof that's necessary um basic timelines a 510 K statutory it's 90 days there's tons of guidance that go through there's so many different scenarios there's administrator reviews and clock starting and stopping and what I tell people in your product development schedules put in a hundred and twenty days on your project schedule your Gantt chart for a 510 K because it's going to take more than 90 so put in some buffer a PMA again statutory is six months hundred and eighty days but I always say a year just plan on a year because there's lots of clock stops and all sorts of snares we won't get into but um so again for the actual review process for a 510 K put 120 days on your calendar for a PMA put a year um again detail of content you've got to talk to FDA and find out what that is 510 K easy look through 510 case summaries there's a ton of them out there and just see what others have done and that'll give you a good gauge on what you might need to do okay great thanks so much um there it is a question that some of those asked about whether there will be a PDF of the presentation slides and I would like to answer that because as a federal agency we would need to post things in an ad a compliant manner that is not possible but if you reach out to me directly after this presentation I would be more than happy to share them individually with you as a audience participant so um that is the answer to that person's question the next question that I would that our audience has is when would a software system be treated as a device um software just like any other device if you're you know the definition of a medical device if you're mitigating curing whatever that definition of medical devices you you are a medical device um I know catching me off guard there are it's a big hot topic software because it runs all of our devices pretty much there's lots of applicator like phone apps and ipad apps FDA's got guidance documents going on all over the place about that um mdds medical data device orange help me out with the name of that one Chris mdds too yeah yeah it's a guidance document it very nicely lays out scenarios where you need to get FDA clearance first scenarios where um how is a term they're calling it a regulatory oversight they're they're not requiring it to go through the agency because they're considering in a lower bar um I think its discretion regulatory discretion that's the word um yeah I know mdds I bet if you go into the FDA website and type in mdds that document will will pair up but it's if your software its same definition for medical device if you're curing mitigating etc or an accessory to a device that does that in a corollary guidance document that our audience members may want to also look at is the mobile medical apps guidance so it sort of goes hand in hand with the software development guidance document if that is the area in which you're working exactly good point so there are two question in here that I don't feel are appropriate for us to answer in this hangout I'm going to mention the two questions this just so that our audience knows that we're acknowledging them but we are going to talk in a minute about some potential hangout topics for 2016 so the questions are does this type of information that you share today also apply to the new guidance coming out for the laboratory developed test that most will be class 2 and also request to explain the difference between CLIA and FDA regulations and because today's presentation is focused mostly on medical devices I feel that these questions although very pertinent and current I may relate better to a future hangout which will focus on the development of in vitro diagnostics and no doubt also lab developed tests because that is a very current topic even just today there was a house and energy committee meeting where the director of CDRH was speaking about the proposed new laboratory developed test guidance document that is expected to be issued so um I'm looking and at this point that does cover all of the questions that were submitted do you have any final words of wisdom or guidance or audience participants that you'd like to share today Lori um I think in closing I would just say is just comb the FDA website look at what others have done in those five ten case summaries that are public on the website and engage FDA don't be afraid to talk to them that they will give you clear feedback through their pre sub system and go early go often to use FDA's term from the past very wonderful thank you and i would like to also just remind our audience that this is the third hang out in our series in the first due to dig cover both navigating the FDA website so you can find some of that information and then these sort of first contact aspects of interacting with the agency so to close at this first inaugural year of regulatory basics Google+ Hangouts we will be having a another hangout on the sixteenth of December at two o'clock eastern standard time and that will be focused on an overview of both drugs and biologics regulation and the URL for the Google+ page is there on that slide and we have a number of proposed topics for 2015 and those include a overview of in vitro diagnostics regulation quality system regulations 101 identifying predicates and an overview of orphan product development now these are just proposed topics not definite topics at this point in time I absolutely welcome your suggestions for additional topics or more timely topics this series exists to meet the needs of our NHLBI investigators and other small businesses and biomedical innovators in this space I don't want to be too device heavy so please help me identify some additional drug and biologic related topics that are of current and RF current interest and then finally I would like to close out today's hangout by saying thank you so much for your attendance these hangouts are organized and presented by the NHLBI office of translational alliances and coordination and if you are developing a product or technology that fits within the NHLBI emission space which covers cardiovascular pulmonary hematologic or sleep disorders and diseases you may contact us through our website listed here for additional assistance and find out about the SBIR and other funding opportunities that NIH does provide to our investigators and if you are developing a product or technology that falls outside of NHL the eyes mission space you can please use the resources that are presented in this hangout to reach out to the appropriate office at FDA or Institute at NIH for additional assistance and thank you again so very much and thank you Laurie for such a wonderful and informative presentation thank you very much

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