FDA 510K Premarket Notification Webinar



welcome and thank you for standing by at this time all participants will be in a listen-only mode until the question and answer session of today's call at that time you may press star 1 to ask a question from the phone lines I like to inform all parties which today's call is being recorded if you have any objections you may disconnect at this time right now at the turn the call over to miss Irene I hear thank you you may begin thank you hello and welcome to today's FDA webinar to discuss the recently published final guidance document titled by 10k program evaluating substantial equivalence and premarket notification I am I arena here of CDR HS office of communication and education and I'll be your moderator for today's discussion on July 28 FDA published the final guidance document which clarifies the current regulatory framework policies and practices of the 510k premarket review process today Marjorie Schulman the director of the premarket notification program in CDR h's office of device evaluation will present an overview of the guidance document following Marjorie's presentation we will open the call for questions at that time Marjorie and several other regulatory experts and CDRH will be available to provide clarification and answer questions today's slide presentation audio recording and written transcript will be available on the CDRH learn section of the FDA website now I'd like to turn it over to Marjorie thank you welcome my name is Marjorie Schulman and I want to thank you for taking your time today to listen to this presentation we hope you find it helpful and informative first I'll start with a little background k 86 3 Blue Book memorandum the guidance on the CDRH premarket notification review program also known as 510 K issued on june thirtieth 1986 there is a general description regarding the process of determining substantial equivalence between a new device and a predicate device it issued prior to FDA implementation of good guidance practices the new 510 K paradigm alternate approaches to demonstrate in substantial equivalence and premarket notification guidance document issued March twentieth nineteen ninety eight it introduced the special and abbreviated 510 K program and it explains the differences between traditional special and abbreviated 15 k s with respect to the scope and Submission content neither document has an updated since neither document is an updated sense initial publication but for the background the draft guidance document evaluating substantial equivalence and premarket notification 510 K issued to summer 28 2011 there is a grand undertaken undertaking by a number of dedicated FDA's FDA employees who put in a lot of time effort and thought into this document it's intended to offer greater clarity on topics discussed in k 86 3 and the new 510 K paradigm Giants documents we received over 400 comments most of the comments are on the special 510 K technological characteristics and predicate device sections FDA carefully reviewed all the comments and modified the draft guidance document to address those we do believe we reviewed all the comments into each one into consideration and as a result we did as I just said a modified the document so the draft guidance document was revised to give a clearer to clearly clear explanation than the intent and value of the primary predicate concept which I'll explain a bit later include more examples to illustrate FDA's decision making process which we hope you will find very helpful and including the appendix with a sample 15 case summary to demonstrate the level of detail expected in each session affection which all also go into more detail later in response to the comments there were there was industry concern related to the inclusion of the special 510 K program section given the connection to deciding when to submit a new 510 K for device modifications so we heard you and in response the special and abbreviated sections were removed FDA intends to finalize these sections separately and the new 510 K paradigm guidance remains in effect but now we'll move on to the discussion of the final guidance we are announcing the availability of the guidance titled a 510 K program evaluating substantial equivalence in premarket notification 510 K it describes FDA's current review practices for 510 K submissions by describing the regulatory framework policies and underlying practices it does replace k 86 3 guidance and it was issued in accordance with FDA's ggp regulation 21 CFR 10.1 15 the guy in highlights is there is a flowchart modification discussion of new term illustrative examples for different not substantially equivalent categories and a 5-10 case summary context context context a Content explanation I know what I'm saying we'll get into further detail on these subjects in the following slides for the flowchart modification it's been previously unmodified since its introduction in k-8 e63 and there is updated to incorporate statutory terminology and the language mirrors section 513 I of the federal Food Drug and Cosmetic Act and 21 CFR 807 point 100 it is cosmetically reorganized its for increased clarity and visually streamlined it is available in Appendix A of the guidance document and it's not intended to be used to the standalone document the most important message about this flowchart is the decision points did not change we've introduced some new terms primary predicate and reference device primary predicate is the device the identified predicate with indications and technology most similar to the device subject to the subject device when multiple predicates are identified and this can facilitate a tiling review and well supported decision a reference device is a legally marketed device intended to provide scientific information to support safety and effectiveness reference device is not a predicate and cannot be used to support decision points 1 through floor for on the flowchart there are illustrative examples of each in the guidance document and there's a glossary of significant terminology and appendix D other terms that may not sound familiar are one multiple predicate which is where two or more predicate devices that have been provided to fort NSE decision if using multiple predicate devices to demonstrate substantial equivalence each predicate device must have the same intended use as the new device and any different technological characteristics between the new device and the predicate must not raise different questions of safety and effectiveness multiple credit kits can also include devices such as a multi perimeter monitor and in a vise construct examples are available in the guidance document and everyone's favorite term split predicate which is using one legally marketed device for intended use and a different legally marketed device for technological characteristics to demonstrate substantially equivalent the use of split predicates is inconsistent with the 510k regulatory standard as we try to clarify this in the guidance you do not need a primary predicate you do need a primary predicate to get you through all the way through the flowchart this is not a change from how we have made decisions in the past so the illustrative examples the NSE categories are unchanged and fully explained we have lack of predicates new intended use different questions of safety and effectiveness and inadequate performance data the first three remove the device from the 510k pathway the fourth inadequate performance data allows the device to be resubmitted as a 510 K with the adequate data we also have multiple examples of each NSE type described in the science and finally in one guidance document we have discussed both intended use and indication for use the 510 case summary is part of this guidance document and the guidance includes additional discussion and examples on 510 case summary requirements and context Appendix B is a discussion on the 510 case summary document requirements and it provides clarification to facilitate compliance with 510 case summary content requirements which can be found under 21 CFR 807 point 92 each sub part of the regulation is explained with suggested contact content appendix e is a sample of a compliant I 10k summary that's intended to provide an example of the format and the content expected the information required in the summary follows 21 CFR 807 point 92 we believe by following these requirements the summaries will be more helpful to companies by showing what information was required for the predicate and will increase transparency a file will not be refused during the refuse to accept process for missing information in the summary this will be a substantive review item but the summary should contain all the elements outlined in the regulation one of my favorite scenes by George Bernard Shaw is the single biggest problem in communication is the illusion that is taking place we hope you find this guidance helpful and it's clarifying the 510k program for you we want to continue the communication so doc comments on this final guidance may be submitted at any time to the following website and electronic comments wwa galatians gov we will now take any questions on this guidance or comments or accolades thank you for participating you can send your questions to the division of industry and consumer education at dice at fda HHS gov and for more information on the regulation of medical devices please visit CDRH learn and device advice in the medical device section of fda gov thank you thank you if you would like to ask a question from the phone lines please press 41 you will be prompted to mute your phone and record your name again it's star 1 to ask a question one moment please for the first question and there no questions thank you at this time I think we should just give it a few more minutes can you just double check to make sure all of the caller's understand how to confer question absolutely again to ask a question from the phone lines please press star one ok and one moment we do have a question in queue our first question comes from Sam Martha sir your line is open hi this december's are from philips healthcare mr. Coleman I think you alluded to it in your presentation that special and abbreviated pipes and cater excluded from this guidance is that correct yes that is correct but they still are in effect under the new 15k paradigm we gotta track it came out it was included all in the draft that we addressed specials and abbreviated but now it's been we removed it from this guy in stock document and the other one is still in effect so we that has not changed it all we're still accepting them very good thank you welcome okay we can take the next caller please thank you and our next question comes from Greg Levine sir your line is open because I thank you this is a Greg Levine with ropes and gray thank you for their presentation in the guidance have a question about the the use of the primary predicate by FDA and wondering if you could explain a little more about the purpose of that and the function will serve from FDA's perspective and in particular I'm thinking because the FDA has said it will accept multiple predicates opportunity if you have a device that combining features from other previously clear devices you know what so if I have let's say a device is combining features from two previously clear devices what is the purpose of identifying a predicate because it seems like in some instances that could be frankly some of something of an arbitrary determination which one's predicate vs but which one primary versus non-primary thank you that's an excellent question the purpose of the primary predicate is the device with the indications and reuse and the technological characteristics that are most similar to the new device so it should be identified within the fighting k submission the multiple predicates are certainly allowed also but you need one primary predicate to get you all the way through the flowchart sometimes two things could be equal and you are just picking one to be the primary predicate you can also would on for a multi perimeter monitor you could have the primary predicate be that monitor so it's really a combination of a lot of devices I'm sorry what was the other part of question was well I mean that you know I guess I guess that answers that is a question that addresses whether you you know the decision frankly could be flip a coin in some cases I guess what I'm really trying to stand is when you know why is why is FDA requiring a primary you know what is what is the role of that and how does that frankly so that's not new to the program we've always required a primary predicate and its really to determine a substantial equivalence so you need a legally marketed predicate device and the legally marketed predicate device can be one that's been five Kincaid it could be one that was pre amendment twice it could be one that's been reclassified or de novo device so that's your primary predicate but then you may change the indication for the technology and that's where you might bring in other examples but you have one primary predicate that has the overall intended use of the device that you're looking to market thank you and our next question comes from Patricia Lehman your line is open hi thank you sis Patricia lineman from in your core and I was just wondering if you could tell me if the agency anticipates that there will be any changes on the application forms that might reflect any kind of new term in the new guidance I'm sorry that changes on the application form yes are the cover sheet are you talking about the cover sheet for any of the corn yet yes we are looking to update any forms that do need to be updated for these changes and then we're just looking to update that anyway to make some just cosmetic changes that were needed anyway but we will announce those when they do come out in the meantime you're welcome to use the forms that are out there they're still valid for logging in ne 510 K or any application and the information that we pull off of them is the same for the trade name and the company name and the email address etc hey thank you thank you thank you and our next question comes from JD sir your line is open yes thank you very much my name is Jane keep calling you from any discorporation in Ottawa the question is not exactly on the guidance but on the mechanism to provide the information to the FDA if the electronic method is the only method to be used to communicate with the FDA for submission of a 510 cake yes that's a good question we do require an electronic copy of your 510 K at this point I like trying to copy and a hard copy we don't accept just a hard copy see we do have an electronic submission guidance document that's available on the way I can walk you through that on how to submit that so any information submitted to us even as a supplement or anything that comes through the document centers should include an electronic copy okay thank you very much thank you thank you and our next question comes from James fedora sir your line is open yes I James fedorko from sylvan fiber optics were we have a product that was 510 K back in 1991 been around for a while and we're looking to we're exploring another product would be we feel that are substantially equivalent to the product we have but I guess if you could please explain to me what a split predicate is please so a split predicate is uh what we do not accept and we haven't accepted in the in the past maybe I'm sure someone out there probably can come up with an example where we have what a split predicate is where you're taking one legally marketed predicate device and it doesn't get all the way through the flowchart it might be not substantially equivalent for a new intended use and at that point you're bringing in another predicate to get it further down the flowchart and technology so really it's kind of like a it really doesn't have a full price if I can get you all the way through the flowchart it's some almost an imaginary device at this point because we don't have a legally marketed predicate device court okay well so our product then it is already 5 10 8 and the new product which will be manufactured will be actually private labeled for us it's five in a 510 K but as a I'm not sure if it's going to meet exactly the wording so to speak in oil 510 K we originally filed that's that's okay that's the beauty of the 510 K process you don't have to be exactly like your predicate you can have a new indication for use or new technology okay great right well very good thank you very much grateful to appreciate it thank you thank you thank you and her next question comes from bob hoy your line is open hi Bob boy from searchable frontiers here thank you for the presentation period I had a question about the reference device example one in the guidance and as a predator who it seemed like the actual subject device and the predicate device the subject device would have made it all the way through the flowchart without the reference device so my question is what what is the purpose of the reference devices if the rationale or the performance data is enough to to tell us that the difference in technological characteristics raises no known issues of safety or effectiveness why would a reference device be included so we're not saying you need a reference device per se we're saying if you have a reference device that may help the review then then it's certainly helpful to add that if you can get all the way through the flowchart with just the predicate device a reference device is not needed if there's some information that we may gain from the reference device that maybe it's a material that's been used before so we know what kind of testing or questions are asked or the material of the device itself or anything like that that's going to be helpful in the review but it's not a requirement to have the reference device it's just any other information you may know about the your device that you think would be helpful in showing substantial equivalence okay so even though it has different indication for use the technology has been cleared and it's helpful to understand how it was cleared right so that's that's a helpful for us and probably helpful for you too if you look at the other companies 510 case summary and especially one of these new ones that it will appear on the web soon that that will show you what testing was required for that technology and because as previously before and now new indications go through 15k all the time so does different technology as long as it doesn't raise different questions of safety and effectiveness okay great thank you thank you thank you and our next question comes from Maui ma'am your line is open my question has been answered thing thank you had our next question comes from Ivan Stengel your line is open thank you I am participating only via the audio and I don't have access to I didn't have access to the slide so this may have been more obvious in the slide but if we're developing technology that appears have substantial equivalence to legally marketed devices but it's a new application in a new part of the body with that then require additional demonstration of efficacy and safety for that particular new use I would yes so we're going to look at the indication of where on the body it's being used and then that's probably going to need some kind of data I would probably suggest that you submit a pre-submission to the division to make sure that everyone's on the same page before you go off and and do any studies for the data so that's that's a tool available for you too but that's probably going to need data okay okay sorry yes okay thank you thank you thank you and our next question comes from Lorraine helvetica your line is open I'm yes I am good afternoon my question is regarding the actual designation of the primary predicate is FDA now requiring us to actually state in the submission this is the primary predicate or is it just inferred as you go down the checklist that this is the primary and because I think another gentleman might have stated that sometimes it is a gray area because you actually have to that could both be primary predicate sand you're trying to combine and give a lot of information regarding the fact that you have a couple of predicates sighs could fit the bill so and then in terms of a reference device do they want you to actually stay this is a reference device or you're just using the back of information and there we would not that's a great question and we should have made that clear we would love for you to to clearly label what is the predicate device and what are the reference devices that's going to help us kind of build like a predicate tree on what would substantially equivalent to what and go back in time that way and then the reference devices we know if all things being equal and there's two primary predicates will then really you just get to pick one okay great thank you very much just an addition if there are two you would pick the one with the higher class and the one most like the device you're claiming equivalents to what if all those things are equal then you're just pick one okay fantastic thank you for your assistance thank you thank you and the next question comes from staying Jambo sorry your line is open thank you very much mr. lanai my name is Steve ziemba am a little bit confused on the difference between splitting predicate server or the infinities perhaps as well as better way to look at that and multiple predicates in other words I believe what you said was a split predicate the device that at least one device has a different intended to use whereas multiple predicates would have the same intended use except I heard you say several times that you could use the biood inking process to expand or add new intended uses or indications which I would presume would have needed some data from either some sort of safety and effectiveness study or from another predicate so if I can't bring it in as I split predicates and I can't bring it as a multiple predicate how do I bring it in so um no that's a good clarification and you're right that the difference in indication for user technology probably would require some kind of data what we're saying for a split predicate is that you don't have one predicate device that can get you all the way through the flowchart and that was not allowed previously in the 510k program and we just clarified it for this guidance document so what you're talking about if you're using a reference device or another predicate you can bring that in as long as you have one primary predicate to get you all the way through the flowchart to use the exact well do you see the example in the dinosaur got a knee implant whatever it wasn't there that it's cleared with material any and what indicated uses and saying well I want to bring in another the implant as you know made from a different material and maybe it's for a slightly different population like maybe an older or younger population is that appropriate to use as a multiple predicate that's a multiple predicate no I'm sorry that's a reference device I'm sorry oh but some of all of us i can write this is this is dr. jody boy from the office of device evaluation is so just to clarify the example that you're talking about is actually a reference device we don't consider a reference device a predicate when you are utilizing multiple predicate it is two or more devices that you can walk all the way through the flowchart and so the distinction that we're trying to make with identification of a primary predicate is to pick the one predicate that you think is most similar to your product it's not a requirement that you have to only identify one but it helps to streamline the review process because we look and your characterization comparison is done to that particular product so that's the impetus for a primary predicate is to try to streamline both the testing that you do on your end as well as the review process on the agency side thank you thank you dr. Foley thank you and our next question comes from Craig cones sir your line is open hi this is Craig combe terms medical device consulting a Michelin up we're still trying to sort through this issue of when different technological characteristics raise new questions of safety and effectiveness and you provided several examples and I'd like to focus in on that first one that you did of showing the different technology and have the same intended use as far as serving as biological indicators that's on page 21 um however you know I just when I look at that specific example I don't see that they do raise new questions safety and efficacy I mean the main questions of safety and efficacy for any diagnostic like that sensitivity specificity false positive false negative they're the same for both assets now certainly they do raise different testing methodologies because they have different technology different testing methodologies to show that they meet the same criteria I just what we're not understanding particularly cuz I don't want this to be chillin on innovation how is the need for different ways of testing the methodology interpreted as new safety and effectiveness questions so we look at that because these questions were not asked with the predicate device and that's what we consider a different question of Technology so that would be a question that wasn't asked with the predicate device and that's why after would be different again that that's not new to the decision-making process those are ones that we would have found not subsequent before the issuance of this guidance document I can understand what you're saying that it you may not read it the same way but that's what we believe that it is a different question of Technology because it was not asked in the predicate thank you thank you thank you and our next question comes from Robin statins sir your line is open hi this is Robin fastener Tom Tom Ian from a few lab thank you for your presentation in a follow-up that to the last question and I think it kind of leads into my question so I think one of the things that were a little concerned about our if we use a predicate that has a 510 K from maybe five to ten years ago or even further back a lot of time to information or 510 K summary is pretty big it doesn't have as much detail as what FDA is now requesting in this guidance so we may not know whether the agency had evaluated certain aspects of safety and effectiveness in that review so I guess then my question would be does FDA expect to receive a lot more genova requests in some of these de novo request made calm after an NSC letter so it seems I in the guidance there's a lot of examples of when you would get an MSC and based on maybe some of the things I'm hearing now it sounds like there may be a lot more NFC letters that are going to be given out to industry and therefore perhaps more de novo request yes thank you for your comment we do not expect the NSA rate to to increase we do not expect to issue more NSE determinations if you had a question on what information was required for maybe the predicate device you could always submit Q sub and discuss it with the division but we're looking for the change in your technology from the predicate that would be a different question of safety and effectiveness so that you don't necessarily have to know from the summary what was asked on the other within the in the predicate 510k you can also request the file through Freedom of Information if you're interested in that and that's why we're hoping that these summaries that the part of the reg that's been in the regulation since the inception of the summary in the statement is going to help with questions exactly like this thank you once just one other follow-up question does FDA feel that this guidance will have any effect on bundled fighting chains no we do not feel it it should change anything about bundling the 15 case if you could bundle before you can bundle now thank you thank you and our next question comes from Elaine Lee your line is open thank you thanks for the webinar the chance to questions this is Elaine Lee from Intuitive Surgical my question is also on reference devices I was a little confused by one of your slides that said a reference device cannot be used for a decision point on the flowchart but in the guidance it talks about using the reference device for supporting scientific methodology for at decision point 5a so I was wondering if you could just clarify what the distinction was regarding what you're trying to say about not being used as decision point so basically that kind of ties into the split predicate you can't use a reference device to bring in another predicate to get you past that decision point if you don't have a legally marketed device that can get you all the way through the flowchart for the first four points so the first four points on the flowchart so that's why but it certainly is going to be helpful to review and to end for you to include that so we know what kind of information you're looking for so that that's all we meant by that for the reference device that it shouldn't be to get you further down the flow chart but it certainly has a part in the review so you mean that it you can't use your reference device to get you through the first four decision points that what you're correct okay thank you the intended use the predicate the legally marketed products device intended use new technology thank you and our next question comes from quad force online sorry your line is open yes good afternoon this is human this is claude verlon I'm with John Gillespie of data price international FDA consultant we've talked to you before thank you for your presentation and nice to talk to you again I take the opportunity today to ask you to have any plan to open a new category down the road of 10k in the future for lack of a better name I'm calling and labeling this category Amy to product and let me define what I'm thinking about this is when the same device is already clear multiple times by independent OEM of the same manufacturer obviously the situation is the manufacturer did not file a 510 K and then you know that part component is actually a full device and each distributor is filing a 510 K so MVA already has the information already has all the tests safety and effectiveness has been demonstrated we're wondering why how we could short cut in a way a device that's already been approved and in the knowledge of the FDA as an example there is a manufacturer of a dental sensor in France who then is important the US and there is eight companies that are filed the exact same sensor under different names etc and we're about to do a ninth one and we're kind of like frustrated we think this should be simplified and certainly equivalency has been demonstrated so thank you for your question I do understand what you're saying and you're right if the person had filed a 510 K then the private label distributors would be exempt under the 510 K program and that's in the regulations we don't have it right we don't have any plans of making a another type of 510 K has anyone talked to the manufacturer and suggested that they submit a 510 K we have actually they don't want to consider themselves a medical device manufacturer and that's kind of an odd situation because of the physical characteristic of the device you know they are a electronic wafer company but actually the device we produce is the exact device software is simply the additional components but already three companies of using the same software so that's kind of a hard situation we wish we could have access or peer reviewers would have access to information and could say yeah you writes the same thing you know let's take a shortcut we have a ruling here or a second category that allows me to products if I can comment that way and we understand our legal issues of reviewing other people's file but on the other hand this would simplify the work at FDA the money the distributor is always willing to pay the fee and you know the product is the same and you know we think that there should be something about this issue right I understand what you're saying and we may have to discuss this later offline there is something I can discuss with you later about a master file maybe that company would like to submit a master file and there's no charge for that and put that proprietary information in the master file than the other ones could reference it they're still going to have to submit a 510 K but I think we may want to discuss this later offline thank you so very much for to do that thank you you're welcome thank you and the next question comes from Cheryl webinar ma'am your line is open closest York Ragnar thank you for the presentation today I just had a quick question you'd mentioned about the additional we've done some special and abbreviated unit estimated timeline for when that may happen um that's a great question and no I don't um not this year I think that was a bank here for that already thank you thanks sorry sorry none of a better answer thank you and the next question comes from Kelly power Luca chips your line is open hello thank you for the opportunity to ask question I my name is probably can check my work with striker my question is in regards to combination devices so I notice here that a guidance of signed off by CDR a chance uber and I guess my question is more of us when you have a combination product you're taking to regulated components that have say that have the same intended use but when you add them together you're inherently altering the technological characteristics it is a kind of indicating that without being able to use predator most common to products what has to be we have to get on the path of either a de novo or a DNA so that may be a bit specific for this because we do have plenty of 510 K devices that may have a drug component or a biological component it doesn't necessarily mean it would be not substantially equivalent we may have to go to the office of combination products see who which center would take the lead on it um okay book that's go ahead so would you be able to reference both it put both of the the drugs device were legally marketed before and you would be able to talk to balloon which you have to pick one of those as a practice session you would need to pick one as a primary predicate and then if you're adding the drug or the by logic but we may have to discuss this if you have something specific in mind as opposed to just a general question will probably want to discuss that with you before you get on the path of submitting any kind of application to make sure it's not a enemy or anything like that great thank you yeah new molecular entity thank you and our next question comes from Abby Micucci ma'am your line is open hi my question is around primary and predicate and reference devices and so for submissions that go and now is it an FD expectation that every submission if there are multiple devices clearly identify primary and reference devices um and if you didn't get did get a submission for the in the next month or so we're a primary predicate was not identified clearly would you refuse to accept so no we would not refuse to accept it in anything that's currently under review we're not going to contact the companies and go back and ask for which was the primary predicate in which were the reference devices it's just for any ones in the future and if you have one that you've already prepared and it's ready to be send here we don't expect you to redo it at this time either so it's not it's not going to be refused to accept item thank you so much thank you thank you and our next question comes from Harlowe till key sir your line is open this whole talking the Starkey Hearing technologies thank you for the seminar a chance to ask questions I was looking at your table and I was wondering if you add though Kate using that table as well for determining whether you need to send in a 510 K for a modified device or if you can have use that to help you determine if it a letter to file is sufficient so no this is not the guidance document that you would make that decision you would go to the window submit a 510 K for a change or modification that document is still in effect and that's the one that you were referenced to make that decision on whether or not it's a significant change that would require a new 510 K okay all right I understand I just need some clarification yeah no thank you thank you and our next question comes from Raj sir your line is open oh yeah hi this is rajesh McGurk as you would say I think you actually already answered my question my question was same similar to the one pose before as to when this is effective and if we are submitting in the next few weeks would you expect this new terminology right so for further reference device and all that the summary of course we would expect to follow the regulation but it will not be a refused to accept title thank you and our next question comes from Marcia hooker ma'am your line is open good afternoon thank you um do a lot of work with point of care devices and so we're working with whole blood devices usually we have a point of care predicate and a laboratory analyzer as a reference analyzer absence the point of care predicate could get us through points 1 through 4 in the flowchart but it be then reasonable assume that when doing the accuracy studies the method comparison studies be done to the reference is more for which is generally assumed to be closer to truth and another point of care device that is an excellent question which I do not have an answer for you right off the bat I can tell you a couple things that you can do right now there will be an IV d roundtable scheduled for Tuesday November eighteenth 2014 but in the meantime we can have you contact our division of my ivd devices and they could help you with that specific question I don't have the response right here but we would we will get you their response as soon as possible so you can send it the question to the dice address at fda HHS gov and we will certainly get you a response i'm sorry i don't have a response for you now okay thank you very much selcuk send a note to the dice email thank you thank you and our next question comes from John beasely sir your line is open thank you very much a question relates to understanding all these definitions when you put them together so for example we note that you have definitions for intended use you have definitions for indications for use then you have these new definitions for primary predicate and multiple predicate so when submitting a 510 K for a change in the clinical context or the clinical setting or the setting so you're changing for example from clinical use to home use all right is it a correct assessment that you cannot use your own device as a primary predicate because your original device is cleared for the clinical use because because of the difference in indications for use in 10 days now you can use your own device as the primary predicate and you know the most about your device the only reason maybe we would want to use another one is for any kind of maybe human factors testing or anything that you may have gotten out of the other file to know what kind of data would be need needed going from one setting to another but you certainly can use your own devices the primary predicate okay all right well so thank you very much still confused because it sounds as if it's a split predicate in that case but I'm not really sure so maybe and maybe I should look a little further right now you have a proper we could look at it further and I can further explain but it's not necessarily a predicate you're just bringing in a reference device to so that this has been cleared for the other setting but okay thank you very much without further okay thank you thank you and our next question comes from Brenda halwa ma'am your line is open hi we run the how from I mdx we're wondering that given the fact that you said it's necessary to choose a predicate a primary predicate that will take you all the way through the flowchart is there any advantage in FDA's eyes to submitting with multiple predicates if you already have one that carries you through the flowchart no that's totally your choice in making your best your best showing of how your substantially equivalent to a legally marketed device if there is one predicate and that gets you all the way through that's perfectly fine we're not insisting on multiple predicates it's just if there are additional ones that maybe can help the FDA with the review and then we can maybe leverage any of that kind of information or look up a previous decision to see what kind of questions were asked that's where it may be helpful but it's certainly not a requirement and plenty of devices go through the process with just one predicate device okay thank you thank you thank you and there are no other questions in queue at this time thank you this is Irina here thanks again for participating and for your questions today please remember that the slide presentation audio recording and written transcript that this webinar will be available on the CDRH learn website and three to five business days for this in other regulatory information please visit our industry with web resources at device advice and CDRH learn in the medical device sections of fda gov as always we appreciate your feedback this concludes today's webinar thank you that concludes today's conference thank you for your participation you may disconnect at this time

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