FDA: Getting Ready for GUDID



how I got all this pretty welcome and thank you for standing by at this time all participants are in a listen-only mode during the Q&A session you may press star 1 on your touch-tone phone if you would like to ask a question additionally today's conference is being recorded if you object to this you may disconnect at this time I would now like to turn our meeting over to miss Irene I here maasai here you may begin thank you for calling me I have your pass code please hello this is a live operator may I have your passcode hello and welcome to today's second webinar for FDA's webinar on you di I am Irene I hear a cd-r HS office of communication and education in a moment we'll be hearing from endure can vary the CDRH program manager for the global unique device identification database also called the good ID in derry will present getting ready for good ID FDA's recommended best practices based on our experiences and on feedback from industry after in there's presentation we will host a Q&A session during which and there will be will be joined by loretta chi regulatory policy analyst in the Office of surveillance and biometrics and Annie terrain ER associate director for policy and communications also with the CDRH office of surveillance and biometrics our main goal today is to help labelers of class to implantable life supporting life sustaining and new class three devices be better prepared to get a good ID account and submit information to the database efficiently and correctly now I give you indira good afternoon it's a pleasure to have all of you tuned in today to listen to the webinar the topic of today's webinar is getting ready for a good ID good i d stands for the global unique device identification database as many of you probably are aware by now the UVI final goal requires that device identification information they submitted to the good ID by device labelers so what I plan to do today is to prepare I deal with a very brief introduction to the good ID and followed by a detailed recommended preparatory steps to get you ready to submit to the good ID so let's get started and for those of you who are list who listen to the UDI 101 webinar because this provided a few minutes ago you have the basic information for those of you who did not we highly encourage you to take time to listen to the UDI 101 webinar the recordings will be available next week on our website and that will provide you a lot of information to get you going so again just to recap diversity would listen before you di stands for unique Device Identifier this is composed of the device identifier potion and the production identifier component the DI span is basically the static question of the device identifier and it identifies the specific portion or a model of the device and the labeler survived device the p.i is the variable potion that changes and as you can see it can be the latter the batch serial expiration date manufacturing date and for human tissue and cellular based products it is the distant identification code so these things change frequently and therefore this is the dynamic component of the UDI so together the DI and the pea i will basically make le di so what is the global unique device identification database so the good ideas we lovingly call it is a repository of key device identification information our goal is to have information available to the public once it's populated and we're working to provide that the good IV contains only the static component of the UDI just the device identifier component the production identifiers are not submitted to all stored in the good ID so this means that we're not going to have every single device widget that's out there captured in a good idea all we will have is a record for a given version of a model of a device which is identified by the device identifier we will however capture information about which of the pis attributes meaning the locker the badge the cereal the expiration manufacturing date which is that which is included in your UTI that information we will have in good ideas and i'll show you in just a couple minutes what i'm talking about this slide is a fictitious medical device label and the purpose here that I'm trying to convey is to tell you that a majority of the information in good ID is directly found on the device label so if you see here on the top to see the compu hyper global man that would be the brand name you see the GMD and description GMD and stands for global medical device lemon creature which is a way to categorize medical devices in two broad categories and in the right in the middle here you see the UDI it is composed of the DI and the p.i components the p.i components I have identified for you as a production identifier the expiration date manufacturing date lot and the serial number as you move from left to the right and in the bottom here you see the labeler name and physical address so this basically shows you that a lot of the information that is found captured in the good ID come directly from the label of a medical device we captured additional attributes that a majority are directly found on the device label from moving right along to the next slide here I'm just showing you screenshots from the good ID which shows you what we capture for device information on the top you see the primary di number which stands for primary device identifier number and you see I have captured in brand name here the version of the model number of the device and device description and the commercial distribution end date is the product for example where you were to stop distributing the product you would have to come back and update the good idea with that information on the left-hand side here in the bottom you look at the DI record published you just make a note of that and we'll talk about it in just a minute on the next slide here sliding I should I'm showing this to you just to show you what I meant when I said production identifier we don't actually capture the lot or the batch number what we're asking you to do however is to let us know which of these production identifiers are actually in a top part of your the UDI so if the locker the bag to spar udi your answer would be yes for this question if its serial number then your answer would be yes so on and so forth so that's the information we capture about the p.i but really the main component we use is the device identifier so moving on the next slide is a sort of a pictorial overview of good ID the blue box shows you the submission options that are available and the pink parts on the right hand side shows you the search and retrieval options and we will go through this in detail one by one as you can see there are two submission options there is a file submission option and there is a web interface option and for search and retrieval also we have a web option and we also have some web services and download capabilities so let's take them one at a time starting with the good idea babe interface good idea web interface is basically a secured web applications folks up wanting to submit information to good ID such as labelers will need to get a good idea account we'll get into that a little bit more later also and it's basically a manual data entry option you will get a username and a password once you log in you can put information in one record at the time and this option is suitable for people who may not have a ton of the articles to submit to good ID the good ID hl7 SPL submission option to quickly go over some acronyms here hl7 stands for health level 7 and health level 7 is a standard development organization and what they do is develop messaging standards in the healthcare space and they have put together a structured product to labeling standards which is the SPL standard and we've taken the SPL standard and what they've done is to constrain it to the good ID space and we have technic stl standard and we're going to ask you to take your device identification information that you want to submit the good ID instead of submitting it manually by typing it in you take your information and you put it an XML file and once you have your file together if you look on the right hand side pictorial there you have your green xml file you then send it to the FDA electronic submissions gateway so what is the FDA ehg on the FDA electronic submissions gateway is a way that the FDA receives all electronic regulatory submissions the gateway basically make sure that the submission is secure and the Gateway also authenticates who the sender it so we know if label or a is sending a file to the good ID we have a way to verify that it is in fact label erase and in the submission so once you send it through the FDA ESG babies routed to see dr h once it comes to southcenter we will process it and load it to the global unique device identification database so in this case since you are taking your information and you are putting it as an xml file we want to make sure that the way you put your xml file together works and we are able to take it and load it and process it therefore we're going to ask you to do some testing so there is this thing required and they have information on what testing and how much testing is you need to do on our website so once you complete testing then we will allow you to submit information to the production system and testing helps you and it helps us because we all make sure that once you get the production we have no issues so the technical specs on how to do all this how to format your file as an XML file is all available on our website and again this option is suitable for those of you who may have a large number of records to submit a good ID its resource intensive as you can see the number of steps involved in getting your XML together and the testing required but once you set it up it should be fairly smooth sailing so all the labelers come in and they put the data in good ID and what do we do with it if we don't release it to the public and of course we want to get it out to the public so we are working with the National Library of Medicine as we speak to provide for good ID public search and good ID database download and web services initially we will start out with the basic search and download capabilities and then down the road we plan to provide web services and what type of information are we going to release not everything that you submit will be released there are certain data elements which we consider to be confidential such as the listing number will not be released what we are releasing than not is on our website i will point that out to you shortly but if you remember the DI record published 8 that i asked you to keep in your mind that's how you tell us when your record is ready to the release to the public so you have the ability to indicate that this record is good to go it can be released to the public for once the record hits the DI record published date then it published the article is what we're going to send make available for the public and we're looking to have this capability available by spring 2015 so stay tuned for more information on that as we get closer to the date a quick word about data quality as if you listen to the UDI 101 webinar you know that an important step in UDI implementation is adoption of you di and we are really actively working to get udi's adapted in electronic health records and claims data and registries and so on it's very important to us to make sure that the data you submit the good ID is a top quality and we are working actively to labelers and the things that we are looking for and the things that we have learned so far is that it's very important for you to take the time to make sure you were UDI is constructed as it should be according to the issuing agency standards for example if you are using the gs1 standard and you construct your device identifier number which for you would be a d-10 the g10 has effect check digit number the check digit has to validate if not that jayden is not constructed correctly we are finding di submitted to good ID that are not validating correctly against the check digit so we ask you know we're checking those sorts of things that's number one the other thing too for you to keep in mind is devices come in to see dr h they get approved and you provide us some information and we approve the device based on the information provided then you come in and you register and list the device you provide information there and then you're going to come into good ID and provide us the device identification information so we're looking to see that there is consistency across all these different touch points and if there are any discrepancies we may contact you and try to understand you know what the source of those discrepancies are so the point here is as you gather your data and as you get ready to work on good ID please keep in mind data quality make sure your source systems are accurate and correct and there may be clean up necessary basically the data quality has to be a main theme for you as you work on that ID all right moving on so that's the introduction and very brief introduction into good ID now let's talk about how do you prepare to submit information to the global unique device identification database there are based on our experience working with class three labelers over the last year we have these nine recommended steps that we have that help you prepare and be more ready to submit good ID and hopefully give you a smooth sailing gay people but that's our hope for you and for us so let's let's start right into it so everybody likes to say everything is on everybody's website you know you want information they say go to this website go to that website is all on our website so somebody told me you know it would be really helpful if you kind of give me a map there is so much information on the website and web sites by nature kind of take you tangentially to different places so here is a proposed map you don't have to follow it but this is a map that we think might be helpful so start with the simple beautiful URL WWF dalsu di you come into this page then i recommend you go to the you div section and what does this tell you this will tell you what is a UTI who is a labeler and information such as this if you are ready new to it it doesn't hard to repeat the more you repeat you know the better it gels and active that's what helps me repetition so there is what is the UDI and who is a labeler the question of who is a labeler is something that we heard a lot come up in the UDI 101 webinar and it does can be confusing so take your time and look here gives you the basics then you may want to want me ender to the UDI resources section and here you have our famous final goal it is pretty good reading surprisingly i'm not a bad person but you should read it and you may also want to consider looking at the small entity compliance guide you see it on the slide here right about the bottom there with the little red circle the small entity compliance guide was written to help smaller businesses understand the final rule it may be a little more readable and that are also frequently asked questions which we have gathered over the last year may already have the question you know answer to a question that you have and the training that we work to put together so this is definitely worth pursuing the UDI resources section then you may want to come over to the good ID section the good ID section on the left hand side really as I was preparing for this I realized the sequence of how you should pursue this website for the good ID section it's pretty well laid out if you just follow it from top to bottom you pretty much have it made so let's look what's there if you look at the top the first thing is good idea guidance it's an absolute must-read if you are going to be submitting data to good ID it lays out all the details but they account the device identifier record and of course it is a life cycle for the device identifier record it's absolute must-read so read it in sections reread it dollar it it will help you then you may want to go to preparing for good ID which is really what I'm doing is pretty much telling you what's in that website and if you are listening to this webinar that means you are a class 2 labeler or you are a labeler for life supporting life sustaining and implant devices and you should be doing this right now so a good job and listening to this the information is really on there in the website you once you have done that once you've done and let the guidance and understood what's needed then you go on and you are ready to the cluster good idea Pam and go to that website it tells you what you need to do then you can go to the good idea web interface if you remember the two submission options if you decide that you want to use the manual data entry here you have a user manual the user manual has screenshots and it will tell you how to actually use the web interface so that might be very helpful for you we talked about the xml file submission option the hl7 SPO technical specification files are here that gives you all the information you need to pursue that option the good ID system status another important page mainly because just like any other IT system we do have to take the good idea and this is where you'll find information on when the system is going to be down and enhancements and fixes if we make any changes to good idea we keep a running tab of what has been changed over here which won't be helpful for people too dumb so really if you go from top to bottom I think that's a good map for you that would be a recommendation last but not believe the good idea resources section is very important the good ID data elements reference table it's a mouthful but what it basically does is it provides you a list of good ID data element so all the things that we captured in good idea and if you look you could give you a description and some of the data entry notes to keep in mind whether it's a required attribute what is the length and whether it's numeric scale alpha numeric field this will be very helpful for you as you gather your data on to submit the good ID so definitely take a look at the good ID data elements reference table in fact we just updated this this morning so you have a brand new copy there with more clarity and information that we've updated based on all the questions we have received over the last year you're good to go there moving along so that's the web site map for you and let's say you went through all of that next thing to do is you need to select an issuing agency and as well as you learned in the UDI 101 what is an issuing agency issuing agency is the organization that basically comes up with the way to a fine create and assign udi and they follow iso standards and we have accredited three of them gs1 epic or equus and you may choose any one for you that works for you once you choose a shipping agency you will create the UDI are based on their guidelines and then you need to place it on the label of the device or on the device itself it has to be human readable and machine readable format so you did all of that then what do you need to do then you need to determine which good idea submission option you want to choose again we have to look them web interface for the SPL the web interface is probably for you know those of you with less records to submit hl7 SPL is one for a lot of Records but it's completely up to you we don't limit you to one or the other you may want to do both but the thing to keep in mind though is you must have good standard operating procedures for record-keeping mainly because it's very easy to send a file to SPL and then somebody in your organization can login to the web interface and make a change so you need to make sure that you have good outcomes procedures and make sure your record for all and think that what you sent to us and Watson your own source system you also have the option to outsource all of the good ID work to somebody you could recall them the third party submitter and if you want to do that you're welcome to do so identify them and there are steps that you need to follow the let us know it is so we can actually allow them to submit on their behalf and information on that isn't a good idea guidance fact in it so please take a look at that so then you've done all of that you may gather your device identification data and if you remember the data elements reference table that will be very helpful to do this don't forget data quality there are some data elements that will take you some time together and two dimension on the global medical device nomenclature preferred term again as I mentioned earlier GM DN basically allows you to categorize devices into broad device categories and the GMD and agency is the one that manages GMD in preferred terms you need to identify one for your device if you don't have one then you have to obtain one so that might take time so please take a look at that right away and work for identify a DMD in preferred term FDA listing number only the owner/operator within an organization usually has access to FDA listing number so make sure you identify the correct listing number for your device and think about data quality as I mentioned earlier so now you have the data you've gone through all the material you know what submission option you want and you are ready to go what do you do next well we need you to get a good idea count mainly because we need to know who is putting information into our database because data quality is so important so good idea account is needed regardless of which option you choose whether web interface or the hl7 SPL in order to do so before you ask us you need to understand a good idea account structure and i am now showing you a very busy slide with a lot of you know boxes and arrows going all over and we won't get into the details such as the details are in the good idea guidance except to note that there is a regulatory contact and it is a good idea coordinator user and it is a good ideal able data entry user for each label organization so it is important that you spend time to understand the good idea account structure and the different user roles identify who in your organization will take on these user roles and make sure they understand the functionality and the responsibility that comes with each of those user roles so that's very important to do once you do that you also need to identify dance numbers dance numbers many of you may know stands for data universal numbering system it's mostly used in the financial reporting arena but it is taking a foothold in the regulatory space and in fda particularly and it's a nine-digit number that's assigned by dun and Bradstreet and what we are going to do in good ID is to use the dance number to identify the labeler name and the labeler address so at no point in all the submissions you'd be sending the good ID will you be typing your company name you will just provided the dance number and then we grab the name of your company and address directly from the guns database and in good ID we have three types of uses for dance we use it to identify the good ID account for your organization and we call that the organization guns we also use it to identify the label ardent and what that is we identify the need your company name as shown on the medical device label so if you remember the fictitious medical device label that I had after a while ago i'm just now showing you the labeler name and address as we have on the label so in good ID when you are ready to submit your good idea can't request you need to provide as a dance number that gives us the labeler dame as shown on this medical device label and that's what we have as label or dance and then the third party down this is optional if you choose to use a third party to do your good idea submissions for you you need to let us know who the third party is and it's important because we associate the third party to your organization so the submissions come we verify and make sure that that person is authorized to submit on your behalf so please take the moment understand the good ID structure identify the dance numbers for these different types of users within good ID and let us know if you have any questions so you have a good idea account and you're all pretty much set so for those of you who choose to do the web interface option the manual data entry option you basically request that obtained a good idea account you don't need to do any testing within the system we have built-in capability for you to get familiar with the system by creating draft records as the name implies the draft record is just that it's a draft so it's only visible to whoever creates the records you can create them save them the FDA does not get to see them and then once you are ready you may submit your records now even when you submit your records if you remember you get to tell us when your record is ready for publishing so you may put a future publish date and the reserve will remain in the unpublished state it won't be available for public view so when you are ready you may submit and publish the derive eckerd into good idea for a 12-7 SPL submitters a few more steps to go here and you would have to pattern in parallel as work on good ID we recommend you register with the FDA electronic submissions gateway they have testing that they require you to do and if you already have a test account and some of you do if you are an adverse event reporter you are familiar with emdr then you probably already have an fda ESG account you can reuse that if you don't have one then definitely get a brand new BSG account and then you get a good I detest account so in your case you need to start with the test account and if you remember you have to you have a testing requirement then you complete hl7 SPL testing and please take the time to do title testing the more testing you do the more already you are to go to production we have provided a few test scenarios that must be passed before you get production accounts but that's really the bare minimum other recommendation is to think through the DI record lifecycle and do to make changes to the record and make sure they're all successful and really touched all your device lines because there are multiple business tools associated with different data elements and if you only test the limited ones you may not run into issues that you may encounter in production the goal really is to make sure by the time you go to production you pretty much our issue free and once you're done with testing you will request and get a good idea account for production submissions and then you may submit your records the other thing to note is there is no draft di capability in the hl7 is real option and the studies in testing is very important so if there are any third parties listening and third parties are basically software vendors or companies that may want to put together a software solution to help label or submit to good ID you are welcome to do so you're welcome to test your submission or your solution independently of having any label or clients you can get a test good idea account and if you need any dummy data for required attributes we can tell right back for you for testing purposes only so once you're done with that we talked about earlier about the good ID system status page we have capability for you to subscribe to get good idea email alerts if we know that the system is going to be down this weekend or this friday we send an email to all the users who have subscribed to the senior list and let you know that the system will be down when the system is down please do not send any submissions are trying to send the submissions it's better to wait on the during the downtime and then send submissions once the system is back up occasionally we have unscheduled downtime if that happens with the website to see if we have any information if we don't have it then maybe you are the lucky user who found the issue please report it to us to the FDA urea I help desk so what's the status well as a reward for all of you for listening to the webinar today you are left one of the first ones to listen to the news we presently are accepting submissions from class three medical device labels and devices labelers of devices license some of the PHS act on Monday January 26 we will open for business for labelers of life supporting life sustaining and inclined devices so welcome aboard on Monday January 26 we look forward to working with all of you and we have now provided you plenty of homework to do between now and then so the distance of things you can be doing to prepare you know hopefully you'll find this helpful and we're happy to work with you starting the 26 we also mentioned to you we're working to provide the daddy search and retrieval spring 2015 stay tuned for that and we'll have more information coming soon so we provided all this information how do you contact us before i get into the UDI bit those of you wanting to do the FDA and sorry hl7 SPL work you need to get the FDA ESG accounts or all ESP questions please go directly to FDA ESG I am sorry but they have they don't help desk they support the entire agency so we rather they answer questions about their program so the email address is on there for you but for all other inquiries regarding UDI and good ID whether its regulatory or technical you contact us we are the famous FDA UTI helped us and it has worked very beautifully for us and I think over time you will you will come to appreciate it as well so the FDA UDR helped us you go to our website and you complete a very simple form as you can see it's just us name last name email phone don't forget to give you an email because if you do not and there are people who forget to fill in the e-mail you won't hear from because that's how we communicate with you you put your question and then you hit the submit question button and what happens is it becomes the case and our helpdesk tool we're using salesforce as our helpdesk tool once we get the case the case it's assigned to folks in our team regulatory stuff goes through regulatory people technical stuff gets out of the technical people and we review your stuff and you will hear from a health care staff member and you we will respond to you via email if you have follow-up questions all you do is hit reply and you respond to that same email and it's important you do a direct reply because we need to append to the case and the only way we can append it is if you'd better reply there are people who have had issues receiving it because it's done to this fan poll der so please make sure you can receive emails the help desk and spam us if you will and we are here to help we are looking forward to working with all of you and the last year has been phenomenal for us working with class 3 labelers we've learned a lot and we have provided a fake use and training and this webinar honestly is a direct response by is a result of working with the Levellers and realizing all the steps and rawls and we hope that this will help you out and whatever you do whether you submit help those questions account request submit di records please for take the time to provide us complete and correct information don't forget data quality and there is a ton of information already there you take the time to review it if you send us a question on something that's already out there we pretty much are going to give you the answers authority there anyway so instead of waiting on us you might as well take the time to review what's out there so look forward to working with all of you thank you for listening and we're ready for questions thank you at this time we will begin the question-and-answer session to ask a question from the phone lines please press star 1 you will need to unmute your line and record your first and then last name clearly when prompted if you choose to withdraw your question please start to once again if you would like to ask a question from the phone lines please press star 1 one moment for our first question please our first question is coming from Patricia Rupp shock disrupt childcare question is up at this time thank you on slide number 27 it talks about the different d uns numbers from the previous webinar I understand that if you're a manufacturer and you make a product that is in private labels for another company the other company is a labeler that's as correct right hello yes but correct okay I wasn't sure if I was coming through or not okay can we though put into our own good idea count their information or do they have to have their own account with that information in so if they are the label or they would be getting a good idea account okay so they would have to actually do that they could not request that we do that because we would not have their convent is that correct um in that case you might be the third party if you plan to submit information on behalf of the labeler okay and in both case is in that case either way the organization to you n s and the labeler d uns would be the other companies numbers right yes okay okay that's that helps thank you very much you're welcome our next question is going to come from to show free her manto mr. ha manto your question is up at this time oh yeah hi thank you for the presentation is very informative here I have two short quick question if I may the first question that i have i had a chance to download the good ID tables and i noticed some of the elements or the attributes listed there his mark as optionals does it mean i just like to have confirmation here we can skip them as blank when we submit the data so in the good ID data elements reference table we have yes you are right there are optional elements and then there are some that are called conditionally required so if you have an option few fully completely optional element yes you may submit information without providing that however our recommendation is for you to provide complete information where possible as you know the Enders the end goal of this is to make sure complete information is available for consumers but from a record of substance perspective yes you may be you may be you will be able to submit it and you do not need to provide the optional data attribute I say okay thank you my second question is relate to one of the attributes if called the DI record published date when I look at the data entry notes it says that the day if are not interpret it interpret this thing wrong I have to enter the date of publishing minus seven calendar days is that correct I'm sorry what's the last part of her question what calendar date yep so on the DI record published 8 elements under the good ID tables mm-hmm he says that on the data entry notes that the date determine the grace period the second date calendars start today's after the DI record published 8 so my interpretation the seven days indicates that when we going to submit the data we have to identify the DI record Provost day minus seven calendar days to the actual dates where I would like to have that date is published that correct so this again the the presentation was very high overview we did not talk about the DI record published a car the grace period so your question pertains to the grace period and you need to publish the DI that Gerda and make sure that is in a published state to fulfill the UTI final rule requirements so that should definitely be a consideration when you determine when you're published page should be as far as the grace period and the seven calendar days that is talking about your ability to edit the DI record once it's submitted and the purpose of the grace period is give you an opportunity to make any edits after the record is in a published state noting that once a record is in a published state it's available for publicly or bright so our recommendation is by the time you publish the record it should be locked and ideally you should not have to edit the record unless for example commercial distribution end date you and discontinue the product and you have to come back in and update the record so we would like to see record as stable as it's possible to have it practically by the time it's published so the grace period really is giving you an opportunity to edit the record once it's in a published 8 I think I see ya because the confusion i'm coming from on the same note it says that we recommend you that this date in the future but seven days prior to any compliance date deadlines all right the VI record published it can only be a record it can be set to today or in the future you can't have a data core published in the past that is a system business so that is correct oh I see okay so i can set the date in the future and seven days prior to release i have a great period if I like to do edit on that data before it goes public right the Great Spirit is really your choice too it's just providing you ability to edit the record once obscure how you manage it it's up to you but the published state is which is the publisher the brothers it go public it goes published on the date that is put on the DI record published 8 so if you set the I record published 8 to be today the record will be in published date today and if we had public search available today the public would be able to access your record today sorry I'm sorry but if you have any we would prefer that you do not have to make any changes to it but you have that grace period in which to make those changes but the publish date is still the date that it goes public not to nothing one the grace period ends I think okay so on the cluster medical device the military date to go live in September 24th 2016 correct yes katsu product yes correct and that's going to be the publish date that's the date that is the last date in which you can be in compliance with the right with the data submission requirements under the UDI rule I see saying that we're not in any way saying please wait until sup number 24 2016 when we open the good ID to class 2 labelers we will accept the DI records from that moment on I see I see I think I get it okay thank you very much and they also add and something that if you are a class 3 laidler and you have class two products and you already have a good idea account because you had class 3 products and submitted di records you may submit your records for your class to product you do not have to wait I think got it thank you and same thing for you know if you get a good idea can't now because you have a life-supporting sustaining an implant device with you and you want you get those divides records then you don't need to wait you can continue submitting so anybody who has an account and who have records to submit you can you can set the DI record published it to a future date but you don't have to so you have the capability to submit this whole open for business and giving accounts only the first you're getting the good idea account but as part of submitting di records once you have an account you don't need to wait for those device class compliance date to hit you may submit the only reason we are opening accounts and that is if you will is to make sure that we have the capability to provide the support that you need in getting your account making sure that we can turn those requests that on quickly and we are able to address all your questions so once you know the system go right ahead and keep it submitting you don't need to wait for anything I think uh uh if your your explanation figure another question for me here let's say if the company where I work now also making a drop product and we already have a good idea count right so what you're saying we can use the same good idea account to load at the medical device good idea information is that correct did you say a drug product drug product correct no the good i D is for medical devices only it's not for drugs sold if you have medical devices that are covered under the UDI final rule once you have the good idea count yes you may continue to submit okay all right thank you welcome our next question comes from kathryn williams miss Williams or question is up at this time who is currently pending are we able to apply for a G udid account before we get our final approval or do we have to wait for approval before we can apply to the account and we're sorry miss Williams you're a first part of your question car after you mind repeating the first half please be sure yet we are currently awaiting final approval of our PA and we wondered whether or not we can go ahead and apply for a G udid account before our approval is made final or if we will have to wait for final PMA approval before we can actually go ahead and do that do you have any approved products at the moment no we're a single product company yeah no unfortunately you have to wait till you get approval before you can apply for a tidy account that's ok good at least we know what we have to do was forgettable thank you thank you thank you friends but when you are you keep in mind though although the regulations require or the way the regulations are written the minute you put your product and distribution you're supposed to have it you're supposed to have your data submit and good ID but in fact we're actually giving you a 15-day interval of time because we know that it's impossible for you to to do the simultaneously so because you have to get a list of registration listing number and so forth so there is a 15-day period from the day you put your product first time you put your product and distribution and then you're required to submit the data to good ID ok great thank you for the clarification our next question comes from Brian mcbrian mr. might bring your question is up at this time yes once wondering is it required to use these third party of credit issuers for uti's party what was your question can you defeat yes is it required to use their party accredited issuers for uti's oh yes such as gs1 oh yes so I think you're asking about issuing agency so just to clarify third party the way we use that term in the good ID in do di world is third party somebody you are using to submit information on your behalf so I just I guess I consider them as third parties but I mean the accredited issuers such as ds1 all right so if your question is who should you use to create and assign your DD eyes and yes you have to use one of the three accredited issue engaging yes well I guess my question is from what I understand is the accrediting issuers are is a quite costly thing to take into consideration for small businesses and I'm just wondering how that's going to adversely affect these businesses that are not aware of these costs thank you our next question comes from Catherine no word work we're looking at each other I apology we don't get into the fee structure that the issuing agencies charged however my understanding is they are volume-based so I'm just wondering if it was taken into consideration before your final guidance it was it was wide and I guess why what why isn't the FDA issuing okay so you know the eyes and why are they why are they looking towards needs a party to the first of all let me say that and I don't have the regulations in front of me but the regulations do provide that it for some reason the fee structure is charged by the issuing agency become so cost prohibitive that it adversely impacts the small businesses at that point FDA may may intervene and become an issuing agency but we're not at that point yet so more than we hope or expect to ever be at that point but that provision was made in the final regulations and and whose determination was that is the Congressional FDA I'm just wondering you know who decides and do I would write to well the UDF final rule was reviewed you know by multiple entities before it was approved it was here did there was the economic analysis done by those by the propagation it just seems like it will not covered in a lot of these things that I I think it's kind of it was an overlooked subject to the call I mean cuz there's already cost and just implementing it alone and whether it's revalidated for direct marketing put on you know or whatever it may be I might have to send another fight NK for whatever reason just because of the direct marketing alone so I'm just wondering if anyone not about the costs involved for small businesses um I all I can say well first of all the purpose of this webinar really is to talk about getting ready for good ID so um yeah why I guess I'm I needed to burn myself financially event and other businesses do too so it would be good be kind of nice to get an understanding of the costs that are involved in just signing out when for instance thought work lots to device and I understand you're only working you know trying to get these implantable class three devices and the higher end class two devices in the works first but companies like us need to you know understand these costs two or three years ahead of time before you know we're ready to go you know we wish we could help you but all we can say is they were there was a commenting time when the proposal was out there is what it became final they were several opportunities provided for folks to comment on the rule and the requirements in it so at this point we're focusing on helping people getting ready to submit a good ID just one quick question how long after i submit like I understand after i get the initial di from GS one for instance if i add an additional product how long will that take to be reviewed and be okay to use oh you're asking about that are tools or I'm gonna have an approval so that pre-market approval you know you will have to ask their the correct group about that we do not have any no no I'm talking about um let's just say I have any product it's already readily available I want to add it to the list and good once you have a product and you have a good idea account it takes no time it takes the time that it takes you to enter the information or senator there's no one like to have to review it and then then we'll send it back and they say okay you can use it you know once you come if you do the SPL once you do testing you're good to go we don't they're not going to look at every di record and Bernard we don't need to approve every di okay alright that's good thank you very much great thank you more like our next question comes from Catherine wand miss Wang your question is up at this time hello hi there hello can you hear me yes okay all right my company makes a combination product it is accentuated by logic a drug but in the same kid there are the packaging for devices like a transverse edge syringes some are prefilled syringes so who is the labeler and these vices are not manufactured by my company yes supplied all ready to go in his own individual several plastic case practic container so who is the labeler i think are the labelers and this an UDI amended okay so so when you have an instance of a combination product that is about the combination of a drug and a device the question of who is fertile whether it a UTI is required or whether an NDC is required is a determination that's made under the office of the combination products and and then then once that determination is made then it either goes to cedar or comes to us so without knowing more we can't really answer that question what I know for sure that it is an NDC because at the main one the by logic and it's registered on the lid in the in the drug listing for what about all the little packaging that grows ripped from the device packaging do they need ruby eyes because right now we just say manufactured by the device manufacturer not under my company's name for the individual record unit what yeah what this is a little bit complicated so it's hard to sort of answer this and in this form so can you submit this to help desk and we can answer you more thoroughly okay all right thank you sure and I have another very small question I was down the road it's this FDA udi system Universal which it also can it be useful canada me you know this UDI system is solely for the United States and Foley for products that are in commercial distribution in the United States other countries out there are other countries creating their own UGI systems but this this system that we're talking about is only for products that are commercial distribution the United States hang on we have another question right sorry I'm with Catherine wall but if the company in EU has their own identifiers system can that does that mean UDI do we have to have to it's imported into the u.s. don't know as I understand that the u.s. is the first first country to have this UTI system so whatever you have and did ya EU is first of all probably not official yet and second of all no you have to be in compliance with the u.s. UDI requirements in order to commercially distribute the product in United States thank you thank you to our next quest our next question comes from Paul Hazelwood mr. Hazelwood your question is up at this time thank you with regard to class two devices when would we be able to apply for a good idea count at the moment as I as we mentioned we are trying to do this in batches to make sure that you know we are able to provide the assistance the group that is trying to meet the compliance deadline needs so we will open plus two accounts for ability for class to labelers to get good idea counts sometime this year and we'll keep you posted as we get closer to the date at the moment unfortunately I don't have a date that I can share with you okay thank you you're welcome our next and final question is going to be coming from Dylan Alou mr. Alou your question is up at this time okay yes good afternoon and good presentation I not to rehash what the form and gentlemen had already asked but I have a little bit of confusion about the issuing agency basically what is their primary role what do they provide and is it and are they mandatory in other words we have to go through the issuing agency yes so the issuing agency what they provide is they are basically accredited by us they use the international iso standard to establish a way to create generate and maintain the unique device identifiers so we have accredited the three agencies that we have been talking about gs1 and bacon APA and if you you would basically choose one of them and which you choose one of them then you are in compliance with the ud Idol as long as you follow their system to uniquely generate and assign you the eyes so once you're playing physically generating them or they're just guiding us on how to generate that exactly they have guidelines that you will follow once you decide which one you want to use and you will follow their guidelines to generate the udi's yourself so you will be donating it they'll just provide you the guidelines on how to do it okay so there are middleman basically for the FDA yes no no they're not a middleman for the FDA what we need is to have a standardized UDI system right shunt a mailman but I guess I understand how I the other gentleman saying well why didn't you provide those guidelines because well these three you know systems have been operating in the marketplace already and we did not want to introduce another entirely new UDI systems that would probably be more burdensome to companies and then going with what's already existing okay all right well thank you very much you know you're welcome okay thank you this is irene I hear we appreciate your participation and thoughtful questions recordings of today's UDI webinars along with the slide presentations and transcripts will be available at WWF da co / training third / CDRH learn by friday january 23rd under the tab unique device identification system if you have additional questions about the UDI or the good ID systems please use the contact information provided at the end of the slide presentation as always we appreciate your feedback again thank you for your participation and this concludes today's webinar thank you for joining today's conference as Messiah here has says today's conference has ended please disconnect our audio lines at this time again this does conclude today's conference where this connects all audio lines at this time you see here if you'd like to remain on the line we will debrief in the post conference one moment please

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