eSTAR 5.0, Are You Ready

Hello, and welcome everybody to Estar 5.0. Are you ready with Michelle? A lot? I'm really happy to have you here today, Michelle. Welcome.

Thank you. I'm happy to be here. You share with everybody

few announcements before we get started. I believe this time I have gotten the ish the the chat functioning functioning properly. So if somebody wants to drop a chat in there and let me know. Let's start with a really easy question in the chat. If the chat doesn't work, go to the Qa. Where is everybody dialing in from? Just wanna know, you know Tucson, New York, Germany. Amsterdam, Copenhagen, Boston, Texas, Michigan, Toronto, India, Wales. Wow! Czech Republic, Austin. This is amazing. Bermuda, North Carolina, San Diego, Oregon. I love it. I love it. Thank you. Welcome, everybody. This is gonna be a really great event. And I

we're gonna have some poll questions. I want you to feel free to use the QA. To submit questions that you have for Michelle. We're trying to try to get to the questions at the end. But if we don't we'll also try to follow up with you by email. So don't be shy about submitting your questions. A couple of things at the end. There's gonna be a survey that pops up. So it's just a 5 question survey. And we really ask for your participation in this, because it's gonna help us understand. Second of all, I wanna point out that next week Michelle is gonna be speaking again at a very special summit that we just launched. It's the global regulatory Pathways summit. And she's gonna be speaking about the path to market in the Us.

Herit boss is gonna be speaking from Q. Serve on the path to market in the EU. And Matt Burton is gonna be speaking on Pat's market in the Uk Northern Ireland. It's gonna be moderated, not by me, but by David Fillmore from market pathways. So it's a really exciting line up. Make sure you check that out on med tech leading voice, or look for an announcement in your email. we're gonna tell him something else, weren't we? It's oh, qms, alright. And you tell them.

Yep. So for those of you that didn't see the notice in the Federal Register. It. The Qms. Are published informally yesterday, and it's gonna publish officially, Friday. So it's about a hundred pages and links. The notice in the Federal Register is not necessarily the the context of the regulation itself. So join us in March, and we're gonna unpack the changes and the impacts for you.

Great! That's exciting. Shall we go ahead and jump in with the E star. Tell us.

yeah, absolutely so. You know, as you guys are probably familiar Eastar, or was official in October of this past year and in December. They have already updated the template to written version 5. So there is a lot of changes. So we're gonna go through Estar as a whole. We're gonna do a swap on E star. And then we're gonna talk specifically about some of the changes in Version 5 their impacts. And then we're gonna also talk about what this means or the takeaways that you might can anticipate for future changes in the template

great. So before you jump right in, I would like to launch poll. Question number one. Are you planning to make a 5, 10 k. Submission or Pma in the next 12 months. That's wow over overwhelmingly. Yes. we're gonna give this a few more a few more seconds to run but in the meantime, Michelle, if you want to start sharing your screen.

and I want to give a shout out to Matt in Tucson because, I don't know you. Personally, I don't believe but I'm also located in Tucson. So

welcome, Matt. and everyone else.

Yes, and for all the people that are around the world. Thank you for being up late or early, depending on where you are. And I think you'll find next week's webinar on the seventh about the pathways to market. Really interesting.

agreed, and I'll put a link in the in the in the chat for that as well. Once once once the presentation gets underway. So 67%, yes, 13%, no, 19% uncertain. That's great. Gonna let this run for 3 more seconds. And nearly everyone answered, so thank you for your participation in poll question. Number one. It really helps us frame, you know the conversation. So thank you again or participating end poll share results.

And those are the results. If you can see them. can you see them?

Umhm Yup, 68%? Yes.

okay, great

I will stop sharing and get out of your way.

Okay, can you see my screen? Now?

I can.

Okay, yeah, there's. And so we'll get started here. So if we just look at the basics of Estar, the template itself is an interactive Pdf. and it's a form that guides the applicants through the process of preparing a comprehensive and complete medical device. Submission. The it is automated so the form construction has got some auto fill sections. The content and structure is complementary to the Cdr. H's internal review templates. And it's an integration of multiple resources that include guidance documents and other databases. They have guided instructions for each section, and the best part is that there is automatic verification built in

the software and operating systems required is acro dot acrobat, pro DC. Or the latest acrobat, acrobat, pro windows, versions, or foxit. FDA created this to create advantages in their own review process to make it more efficient and consistent, and to improve overall productivity. It also fulfills a Medusa commitment that they made to streamline and make more efficient. The pre-market reviews, with the goal of ensuring patients more timely access to safe, effective, and high quality medical devices. So, as we mentioned before, this was mandatory, as of October 1, 2023, for all, 15 k submissions. They have to be used submitted using E. Star and the pre-submissions Denovos and Pmas submitted through Eastar are still voluntary. Until further notice. But you can anticipate that those are gonna be required probably sooner rather than later, especially for the pre-submissions

starting February 4, of 2024. Only version 5 of the template will be accepted, and older versions are gonna be retired effective that day. So this also means that if you've got an E star if you're in the process of building Eastar with Version 4, you need to retire. You need you. You will need to move to version 5 before you submit. If you're not going to make it in before February the fourth, which is this Friday. So something that's interesting is that if you are working in a version of Eastar, you can't necessarily assume just based off of the links on the website or the names of the links on the the FDA website that you're working in the current version, because right now, if you were to click this link, it doesn't look download just version 5, but it downloads the most current

revision, which is version 5.1. So they've already made a change to this since December when they launch version 5. Yeah. So version 5 was released December the sixth. It includes increased cyber security details, improvements to the flow of the biocompatibility sections, and it added a lot of detail to the clinical investigation updates. And we'll go into some detail about what those changes were and what they mean later overall. Eastar represents a changing strategy to FDA's Documentation Review prior to Estar and the E copy format. It was more of a pull documentation from the FDA about any any documentation that the FDA felt

either wasn't in the submission or wasn't complete and accurate in submission that they would have to either write an AI or send interactive request to for that information with E starts more of a a push in from industry to the FDA, because the template is expected to to help flush out in advance while the is being compiled, so that manufacturers push the right information, and enough of the right information to the FDA.

I understand that there are as many as a hundred different or or more separate Pdfs that get attached.

Yup. So we will talk in depth about the the attachments. It's really tricky because you have to. Normally, there would be in like a traditional E copy, there would be multiple different attachments here. You're supposed to consolidate all your attachments for a particular section into one giant attachment which causes problems with pageination like, How do you, page name based off of the overall count for the the total Pdf, or do you pay donate across like for each sub attachment within the attachment. So it gets, it gets a little unwieldy for the Pdf.

so it's an interactive review format basically on how you answer questions, opens up or closes down different sections of the of the the template. So by selecting a pre market notification for a it is going to automatically close off questions that are only applicable to Denovo or Pmas. So by selecting pre-market notification, then you've got an option to select select which type of pre-market notification. New in this version, 5 in December is that they've added Pma in addition to the novos and so then it just continues to to build custom content based off of your answers to the questions.

So you're supposed to streamline supporting attachments like I just mentioned, you combine at attachment, so that you only have one attachment provided in E star to each question. So so each question will have a section where you can upload an attachment relevant to that section. And and all of the questions in that section

one person asks, Can we do zip file attachments?

That is a good question. I don't believe they. I have not used a zip file. I've I've just done one big attachment. I don't think that they have the capability on the other side to open zip files or links to other file sharing platforms in case it gets too big, and we'll talk about file size. Here shortly. So tips for for making your file attachments is to use smart naming conventions to facilitate finding the attachments. Use things like sub sequential numbering a title that matches the attachment description in the Eastar and then there are acceptable attachment formats that include Pdf word excel and new with the E star is that they'll take

in the past. You did not have the luxury of putting into e copy format. But now with the Eastar that they will, they're they're starting to accept video clips which you can, you know you have, the old phrase, you know pictures worth a thousand words. But now that you can add video to it, too, you know it can tell a whole story about your product and how it works. So but this means you're not gonna have those all those miscellaneous file folders like Shawn just alluded to, where you've got hundreds and hundreds of of random kind of random attachments that that it's not really clear what section that they go with.

So be sure to review all the questions carefully. For instance, the device description that's included in the template. You've got a a part where you can in enter a device description directly in the template, and or you could do it in an attachment, or you could put one level of detail in the template and put a full device description. In the attachment. But be very mindful that anything you put in a yellow text box is can be made into the 15 k. Summary that is publicly available. So anything with a yellow header up here like this?

You need to be very careful that you don't put anything that's a proprietary or overly detailed because, we'll talk about how to build a 15 K summary in the template in a minute. And so that's gonna be really important. So if we look at East. But the differences in E star is a whole versus the normal 5, 10 K's. There is additional traceability information that's related to guidance, documents used, and each section in the template has a has a a subsection to fill in applicable guidance documents that you might have used. Be it a product specific or a technology specific or a scientific like, maybe biocompatibility.

Which this is unique in in the context of how the content, the contents of a normal 5, 10 k. How? Which. if you look at what this infers, though you know, I, when I was in industry, and even still I have clients argue with me that guidance documents are voluntary. Well, if every single section of the 5 of the 5 10 K. Now has an opportunity for you to talk about the guidance document. This voluntary guidance document that you use to demonstrate that you are compliant, or that you fully fulfill requirements? Is it

optional? Is it really voluntary? So to me this is a a big thing that that is showing you where FDA's mindset is around these guidance documents. If you're not going to implement on, you need to be prepared for my. What you did was appropriate or better than what's in the guidance document

would now be a good time to do. Poll. Question number 2.

Sure.

if I can find it. Can you see it?

Yes.

so have you previously use the Eastar program for submission to the Fti one person had asked about if the Pdfs are gonna be confidential. But you mentioned that the yellow part is not. I imagine, that any any attachments are is that they are, that the difference. With the confidentiality.

Correct, correct. It's only the text that's entered in the box that's not confidential. When it has a yellow header. It's everything in the attachment is treated confidential. Yeah, I would think that's an important thing for people to be aware of. So I just wanted to underscore. You know

what is confidential and what isn't. And then there was another question about Pdf. Or word, Doc, I believe the answer is, Pdf. does it matter?

It technically? Doesn't you have the option to send attachments? In a word document? I, personally wouldn't, because I would want to know that what they're looking at wasn't unchanged either, you know, even even unintentionally change.

Okay, so here are the poll results. 27 of 137 people are in previously done this, and 110 are awaiting their chance. Perfect?

Well, then, this is some some good context, then, for the bulk of the people here. Okay, so we'll continue discussing kind of just the E star program as a whole versus the normal way of submitting the in in the old E copy. So of another difference is that now, in the Eastar application you have you have to upload or or attach your previous communications. That includes 5, 13 G's pre-submissions previous nscs, or withdrawals, or Eua's so you can imagine how bulky

size, wisear template could get because you know maybe a pre-submission isn't huge, but if you had a previous submission that was Nsc. Or withdrawal, you have to attach the entire previous submission, which is already huge. plus all your ais that that came with it. So just just be aware that this is a difference, and it's gonna put at the FDA's fingertips. All of that prior communication, so they don't have to go back and look forward in their own records. You you did have to talk about in the old 5 10 case you had to mention if you had one of these. But you didn't have to physically put the documents into the submission. So that's that's a big difference.

So there is a requirement in the in the E star, where you have to give very specific details for sections like labeling. And this is a change that we're gonna talk about in version 5 that opened up even more sections where you have to say cite the attachment number name. However, you've chosen to identify it, and the page number that where they need to look across reference, your answer to some specific questions. So this isn't just an example of the you know. The FDA is not gonna go digging for this information anymore. Again, they expect you to push the information to them, and exactly where to find it in the submission.

So some sections are different, and this is where they took an opportunity to make a lot of things. Make more sense in the way that Estar builds forms. There are several that you don't need as independent attachments anymore. And so things like the separate submission cover sheet and indications for use form have essentially gone away because that information auto builds and populates as the E star gets populated and then it also is excluded. Some previously required forms that in some of these didn't make sense like the class. 3 summary statement as part of

as 20 first century cures. In about 2018 the FDA started reclassifying all that weird little niche of class 3 products that required a class 5 to a a 5, 10 k. As opposed to a Pma, there's none of those left anymore. And so, therefore, that that form has been removed. They've removed the financial disclosure form. and then one of the best features of the Esr is the the declaration. Summary reports for standards. No longer required you to fill out a separate form or report. These are now generated for you in the way that the E start populates. So if we look at a slot or strength, weaknesses, opportunities and threats. Analysis. Of the E star

we have got the strength is that there is no refuse to accept anymore due to this automatic verification that's built in. So this in theory, means that you could get faster substantive interaction in your review. But some people have said that they've seen no difference in the timeline, and the reason is they don't call it rta per say anymore. There's not that form that you have to fill out, or should have been filling out about the Rta process. They don't have to do an internally, but they do do a technical documentation review which they still review your E. Star, and make sure that you answer the questions correctly, and then therefore have the right set of information attached.

So why don't you start? We know of still, the the Technical Documentation Review still took 2 weeks. So it's really no faster than the Rta. So you can't. You can't always guarantee that. So it aligns with the FDA's Internal review templates, and it has the integration of guidance document. Integrations. So you've got these blue question marks that have help pop ups that tell you. You know some informative text or expectations of the FDA associated with that question. So if you're wondering exactly what they mean, there's more context with under these blue question marks. And then the questions, if you answer yes or no, they kind of have a self check built up built in, for instance, like you indicated that the device has wireless technology. But you said that the device uses software and wireless communic. You did not indicate that it has software. Sorry. So how can you have wireless technology and not have software. Make sure that you answered those questions correctly so that could be helpful

to make sure it's consistent. So Strings continued, is you have the option to automate that 15 k. Summary in creation. By clicking by checking. Yes, you would like to either. Yes, you would like to attach one on your own that you you created in a document? independently of this auto creation or no, you want the template to build it for you? So then, that means that any topic throughout the whole template not just the device description section that I gave as an example earlier, but any topic in yellow will be a part of that 5, 10 k. Summary. And anything that you enter as an answer in that text box will be included automatically in that 5, 10 k. Summary, if you check. No.

So again, you know, I just can't emphasize this enough. Be very careful about the proprietary information that you put in those text boxes for yellow prompts. This is what an automatic. 5, 10 k summary looks like we saw one in a recently cleared. Need join. And so you can tell that it auto populates because it looks in almost the exact same format in which the questions were asked in those sections. In the Eastar template. But it has a lot of information in some level of detail that people typically don't put in a 15 k. Summary, because you know, as regulatory professionals, you know that you know your competitors are looking at your 15 K. Summary to be able to say that they are the same or equivalent to you.

So these are very guarded. In the way you craft these, and then also the format while it's more standardized. It's a little clunky in the way it shows up in some of the the sections, particularly in pertinent to the the testing. So if we look at the strengths continued. we have automated completeness, completeness, verification. and so when you start out, it will have based off of the questions that you answered about your product technology. It will have all the sections that you need to populate based off of those answers. And if they're complete or incomplete, so always make sure that these are green and not read so that you can get to a positive effectiveness, verification

we talked about the the a new thing in the Eastar in general is the creation of a standards, forms, and it auto populate. The FDA recognition number and title. So so these drop downs. If you know just one of these numbers, you put it in, and then it's gonna put in the the opposite number of of what you put in, and it's gonna fill in the name of the standard and then and the type and this is also interesting. If you are, you have to select, if you are using this standard for either general use or for a declaration of conformity. So a general use means you didn't follow the standard necessarily to a T, but you used it for a general purpose of maybe a particular test or acceptance criteria selection.

But if you selected a declaration of conformity, that's when it starts building the form the the declaration of conformity for you. So another strength is that once you populate the product code in the classification section, it will automatically populate a guidance document for you. Now, this is not necessarily technology specific, you know, for something like software. But you know, again, this this one we're doing in fusion pump. The guidance document is infusion pumps, total product, life cycle, guidance for Fba, industry and staff. And so it prompts you to make sure that you have considered elements of this guidance document.

But don't necessarily rely on this feature all on its own, because this doesn't include draft guidance documents. Now, you don't necessarily have to be compliant to draft guidance documents. But they do show you what FDA's current thinking is for a particular product code, and it may foreshadow types of additional information requests that you you could get so new new and improved to version 5 is is that when before inversion for and and prior for the Biocompatibility section, you actually had to click through each type of test and put in either a justification for not doing it or an attachment for it.

So now you don't have to. You just select which ones you did. It starts populating the template based off of that, and you put in a single attachment that has all of the bio compatibility tests that you did compiled into a single file. So the this is also an improvement. They've improved the help drop downs and biocompatibility that gives the FDA's interpretation of some of these classifications to make sure that that the way that you you selected to do your testing in terms of maybe the way the communication pathway

or the contact duration is consistent for how the FDA is going to interpret and testing that they're gonna expect. For instance, this is, if your device or system includes a breathing gas pathway component, be aware it is evaluated as externally communicating with contact to tissue. Don't bone and didn't. So if you didn't do your testing to that you know, right right off the bat, you can tell from the help help text your submissions likely going to get an AI. So cyber security was a huge change in prior revisions. It only had, you know, maybe 4 questions that made up less than half a page of the submission drop downs before the answers and attachments were put in.

And now it's gone into several pages worth of the submission and the cybersecurities are for the Eastar. They're they're very stringent. They're very specific now. and make sure that you read carefully, because again, these questions and the Help text are loaded with the FDA's expectations and interpretations, and you have to make sure that you made the right decisions. In your cyber security, documentation and development process.

Yeah, my understanding is that they they realigned 5.0 with the October 2023 cyber security regulation for medical devices. And so now, everything that's in the legislation is is, or in the regulation is in 5.0

Yup. It's exactly right. And we'll talk about that a little bit more in a second. But you, when you remember when I gave the example earlier about the specificity that was required in certain sections like the labeling of what attachment was it in, and what page number is it on? Well, the cyber security has really gone far down a rabbit hole, or trying to avoid the FDA going down the rabbit hole. But now you have to go down the rabbit hole in your own attachment. And now not only do you have to say what section and page number in the attachment? Is it on? You have to break down very specific topics that are required in that particular report or question? And where that topic is not just the broad question in general.

So what this means is that Fba is not playing. Where's Waldo with your 5, 10 K. Anymore? They're not gonna go rummaging through all your attachments trying to look for the specific thing out of the guidance document. And this is one of the things that I feel like is a take away. If you have a lesson learned about what to expect in future. 5, 10 K's or future Eastar versions is, I feel like you're gonna see more and more sections move towards asking for that specificity. And where it's at in your Eastar.

should we do a poll? Quick poll question. And then while we're doing that, you know, there's been one person asking. They think that they're working in a previous version do they need? Does? Does that person need to start over?

Unfortunately, yes. you know I don't, that I don't think that that's required for minor revision. So like, if you're working in 5 and you download it and see it's 5.1. FDA is not requiring the minor revisions to be updated but effective. February the fourth, they're not accepting any more version force.

Okay, so just, I mean, is there any way to update from one to the other. Or do you need to just simply start over?

I don't know if any way to port anything over. I think you're just gonna have to start over.

You know, it's interesting. We've gotten like, really, like hundreds of questions at this point. And one of the things is that I have a request into the FDA to do an interview with David Axel? Who is spoken publicly about this before, and they've asked me exactly what I'm gonna ask. So I'm just gonna take the questions, a lot of the questions which are really, really specific and and forward them onto him as well for comment, and see if we can get an answer from the FDA directly on some of these questions, so might take a while for us to get back to you on on everything. But rest assured. That we will

try to address all of the questions in one way or another presented. Today.

I'm gonna in the poll and share the results. And this time I'm gonna stop sharing the results. Because apparently it was blocking the screen. So I apologize for that. Still getting used to this Zoom Platform. So it looks like a fairly even split between haven't done

on. I don't have products on the Us. Market, a few products on the Us. Market, number of products, and more than 10 products. So it's it's a diverse audience. Thanks for sharing where you're at and hopefully the thing went away this time.

So you know, back to this cyber security changes. The FDA is now requesting, you know, so many details. And so it's it's going to be important again. Not don't just read the question, which is specific, pretty specific already. But make sure you read that whole text about what their meaning and the details that they're meaning behind the question that they're gonna be expecting in your attachments. So like Sean mentioned, this guidance document came out in September of 2023. And it is it? It contains a lot of recommendations that are exactly the same as the E. Star template. So we're just right back to my point of this guidance is the voluntary.

you know cyber security, and yet the E. Star for the content of a 5, 10 k. Is exactly the same. So how can you argue that this is voluntary. When. if you don't answer those questions, you know you're not, gonna you're gonna get a additional information request. So what else is interesting is that I am seeing a people regardless of the you know the classification of their software, the risk level of their product. the likelihood of of it having any type of cyber security issue the FDA is requiring all of this documentation period. Now, maybe your level of detail can vary. But there's it's it's it's a huge undertaking to have a device that has any type of software for any purpose.

So secrets to success. Make sure that you answer your initial questions correctly, or you may have whole sections about the cyber security and the interoperability that are blocked off from being able to be completed. So the FDA has tried to build in those cross section. Reminders of hey? You said no up here, and by clicking. No, this means you're not gonna have access to this section. And for more information, if this applies, go see the guidance document, etc. So a again. You know that help text. Don't just assume that you you understand what the questions asking. Make sure you understand the thought, the current thinking behind the question.

So more of 5 updates. They have started. They've added a lot of detail for 15 K's that that wasn't there previously, and the purpose was to ensure clinical investigation. Supporting submissions are disclosed. and so they have. Not only do they have a lot more questions related to clinical, but then they have a a lot of help that tells you the other regulations you need to comply with and some some context around the clinical data. particularly in the Pma and Denobo section. Those have even more questions related to particularly compliance with 21 Cfr. Part 8. So I to me, you know, these more questions are are actually helpful in some of these areas. To make sure you you understand their expectations.

So weaknesses of the E star be aware that there are file size limitations, so the processing of the submission may be delayed if it exceeds 1 GB and file size, which can be tricky if you get a little video, happy and heavy. The file count combine attachment so that only one attachment is provided to each question in the E star and bookmarks or tables of contents. Are recommended. File versions make sure to use the current version of the E star template for the before complete required content. And again, note that version just because it says, version 5, if there might be a 5.1 5.2, you know so and so forth. So they come out with 5.6 just by clicking through that. The title itself won't tell you that.

So use the most Updated versions of the Pdf. Applications. There is a known Javascript bug in certain adobe acrobat pro applications that causes dynamic Pdfs like Estar to run slower than normal and so this is even directly on the FDA's website, where they warn, warn you of this and warn you of which ones are more friendly, and that they are working directly with adobe to resolve this bug. This process is still being worked out because, you're supposed to submit the e-star through the collaboration, portal or communication. I can't remember if it's collaboration or communication portal. But that II say the FDA, like kind of broke their own Internet here because the even though that it was required. On October one there are known issues with the portal being able to upload some E stars, and in those cases you have to send them in on a flash drive like the old days of E copy.

And you've got to send those to the document control center instead of through the portal. There are several sections that require signatures like the truthful and A/C accuracy, and other ones that the official correspondent must finalize, which can be very tricky, and and a Pdf. Of the of this sort. And and then and then how to manage the attachments how to validate the signatures. So there are workarounds. But but again, it takes some creativity. And in practice file collaboration has to occur outside of E. Star, because the E. Star does not track changes. Your files file sharing of the template itself can be very difficult, and if you rely on interactive editing or editing with multiple people like from a collaboration between the manufacturer and the consultants using solely eastar template can get complex and difficult because you don't know what the people reviewing it who made a change where they made a change, what the change was.

So personally, we still work in word documents outside of the E star, and then everybody blesses it, gives their seal of approval, and then we copy and paste completed sections over into the text boxes which brings us to our next weakness. There are limited text sections, which means there's limited space for viewing and scrolling, and that there's no formatting support supported, and the content again is used to populate the 5, 10 k. Summary, if that's used. So again, don't include confidential information. But here's an example. So no matter how much text you put in there, you only see 3 to 4 lines of text. So if you wanted to work with with somebody else on your team you've got, and they put they put some text in here. You've got to click and scroll and scroll and scroll 3 lines at a time, which is very hard

for text, heavy applications to mentally keep up. Well, what did I just read? What was that last sentence I just read, then you guys scroll back up and scroll back down. And so that's why we we still work and work opportunity. So what does this mean for the future of the 5 10 K program? Well, they're still working towards global harmonization initiatives. Particularly with health Canada. But this still has a lot of questions, because, you know, Canada and other countries have different classifications. They have a a method, classification methodologies. Some devices might be class one in one country class 2 and another. So it's kind of there's a lot

that's gonna have to come together from a regulatory perspective, besides just standardizing the submission format.

It's they plan to continue the expansion to other submission types. Last year they launch both pre-submissions and pmas. We anticipate other types of queue submissions like 5 13 g's coming down the path threats a temp like crashes. It's so big and so slow, yet you could be in the middle of something, and if you didn't save early and often you could lose a good chunk of your work. Another threat is that somebody in your organization made it change, and you didn't realize it. And maybe what they said wasn't accurate wasted time. There's way too much time in front of your computer waiting for this interactive Pdf, to cooperate and to populate or to load or upload

minor template revision changes, or major ones while you're in the middle, like the person who asked the question earlier. and the threats might be mostly to your mental health in this whole process between the template crashing, changing, and your wasted time definitely need to be playing a game on your phone on the side when you're you're trying to upload

shall we do another call poll.

that would be a good cause. We're, this is a we're in the home stretch here, the summary.

Okay, so that's poll question number 4 launch. So this is about your confidence level. Tell us how you're feeling about this. Yeah. interesting, interesting.

What's the verdict? Everybody seem like they're feeling good or

awesome. Be funny to know how many people thought they were feeling good about it. They're like, I don't know about this anymore. 20% are feeling very confident at this point. 19, what's 60% are feeling somewhat confident. And 21% are not not feeling very confident.

So I'm gonna end the poll. Share the results. Thank you all for sharing where you're at the journey. And those are the results. 2160, 19

went away this time.

so just a recap of the strength, weaknesses, opportunities, and threats. And so if we look at you know, what are what are people really saying about this, my favorite is, it's pain short and sweet. But it's a little bit of a of a mix. If people either really love it, or they really hate it. So it's new to everyone even the FDA. So there's a learning curve for for everybody in this process and the user face on the FDA and is different. So they're working out their own kinks as well. And then the FDA has a FAQ, you know will be pu publishing an FAQ. From questions we didn't get to throughout this discussion. And we'll be asking Patrick Axel from the FDA as well from once. We we haven't come across yet.

Rims has a training where Patrick and another gentleman from the FDA actually gave the presentation. So if you want to hear the FDA talk about this directly, if you need more information, you know, be sure to check that out. So if you look at how to optimize the process. You know, there's steps to success which is download the current. E. Star from Fba, populate the required sections. Note the color, if they have changed from red, green, or gray and then at the end, you know. Make sure the status bar, says E. Star complete. But your secrets to success. To get there are, to use the most recent template version, recommend preparing the word document for team co collaboration and then enter that text into the Eastar, utilize that instructional and help content where applicable, even if you felt confident and the way you understood the question do not include confidential information in those text boxes.

Use the smart name naming convention for your file attachments. and save the template after every single change, every attachment, every text at addition, every everything to prevent preliminary crashing. Or if it does, you've lost a minimal amount of work. Make sure you use that verification section to see what's missing, and track your pro progress, and then make sure that each section turns green and gives you an ultimate green status E star complete. Send it electronically, unless you manage crash the customer collaboration portal. again, there's another issue there. So what about requests for additional information? Your first option is to continue to submit responses to additional information request in an E copy format.

or your second is that you can use the eastar templates, and you just se select instead of new submission, you select additional information and then copy the deficiency into one of the fields provided, and then the response into the other. and then new attachments, but it kind of gets a little wonky in the Easter template still. So right now we are still submitted on during through E through the E copy yup. So those text boxes may not be sufficient for providing lengthy explanations that require tables, figures, formatting, etc. So here's some links for you for the for future reference. And so you could cross reference these things if if you need to.

And I've got some templates available these and more on my website. So if you want to check those out and get get some ideas about how we how we go about doing these activities. And then, like I said, we will be getting the Faqs together and following up with you guys about your questions and weeks in the week to come here.

Yes, and as I mentioned, there's going to be a a a quick survey. Which is gonna get sent to you right now. So, or show up on your screen, or something like that as soon as I hit end. So please take a moment to fill out those 5 questions. If you will, we'd greatly appreciate it.

Loved. Having you all here so many great questions. As I said, we're gonna regroup go over them and submit some to the FDA as well, because we can answer all of them necessarily. But we're gonna do our best to try

again. Join Michelle and a number of others for the mid tech global summit next week on the seventh and the at the end of the month I'm actually going to do a cyber security webinar speaker to be announced to help you further with that. So. Thanks everybody for your time and attention the survey should launch itself right now. Thanks.