This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program.
Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.
To discuss this topic, we brought in the following experts:
As of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.
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"Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell
"Even after 30 years, I always open those help boxes in Estar...each submission is unique." - Lisa Pritchard
"The key with Estar is Estar(t). You just have to get started...no substitute for just getting familiar with the template." - Kathy Herzog
Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's podcast. Today we have a little bit different episode. Usually, we have a one-on-one conversation with somebody, but today it's three against one.
Maybe not three against one, but we have three specialists in the area of eSTAR that we want to talk about. So that is Patrick Axtell, who's a PhD and Assistant Director on the tools and template team for the FDA and Kathy Herzog, the senior regulatory quality and compliance consultant for DuVal & Associates and Lisa Pritchard, the vice president of Regulatory Quality, Clinical and Engineering for DuVal & Associates.
I would love to hear just a 32nd intro or origin story from each of you if you want to go roundtable. Patrick, maybe we could start with you.
Patrick Axtell: Sure. Thank you for inviting us, Etienne. My name is Patrick Axtell. I oversee the team that develops tools and templates for the center for Devices and Radiological Health at the FDA.
I developed the 510(k) Smart template used by reviewers to review 510(k), and I developed the 510(k) eSTAR for applicants to use when preparing their submissions for us. And before doing this, I was a reviewer for about seven years.
Etienne Nichols: Awesome. Really appreciate you being on the podcast today. Lisa, what about you?
Lisa Pritchard: Thanks for inviting us. I'm Lisa Pritchard. As you said, I'm vice president of Regulatory Quality Clinical and Engineering. Kind of a mouthful for DuVal & Associates, which is a boutique law firm that specializes in helping companies go through the FDA process.
And I have been in the regulatory space for a bit over 30 years at this point. So, remember submissions well before the eSTAR came into play and pretty excited about how it's changing things.
Etienne Nichols: That's great. I really appreciate you being on the podcast. I love to hear that kind of experience. Kathy, what about you? What is your origin story?
Kathy Herzog: Thanks, and hello, everyone out there. My name is Kathy Herzog. I am a regulatory consultant, also at DuVal & Associates. I've been on board with this FDA law firm for about four years.
My whole career has been in the medical device industry, primarily class two, class three devices, and my background is as a mechanical engineer.
Etienne Nichols: All right, that's mine, too. So mechanical is the best, if you ask me.
Okay. I first was kind of introduced to the presentation you all put together on eSTAR and I at the Regulatory Affairs Professional Society, the RAPS Convergence in September, I think it was.
I didn't get to go to it, which is why I'm excited that we get to have this conversation now. But I wonder if you could tell us a little bit about the story behind eSTAR and I and how that came about.
Lisa Pritchard: I would be happy to talk about that.
Kathy and I are both regulatory professionals at DuVal & Associates, and when the eSTAR program came out and became voluntary for 510(k)s and De Novo’s, we started using it just to get some experience with it before it was required.
And once we started diving into it, we recognized that this was a really great topic to turn into one of our client alerts, which is just something that our company puts out on topics that are of interest to the regulatory or legal community dealing with FDA, as people may or may not know. Usually when DuVal & Associates put something out, we come up with a theme for it, just to give it a little bit more entertainment value than Rayotre and legal usually lends itself to.
When we were kind of brainstorming the topics for this one, probably the easiest one, was an eSTAR is born, which I think I've seen somewhere online.
But we ended up rejecting that one just because the movie has kind of a dark side to it, and we wanted it to be more upbeat, I guess. So, we ended up landing on the East R and I, which is kind of a spoof of the classic Broadway musical The King and I, which seemed to be a much more natural fit, if you know the story of that. It tells the story of the King of Siam, who was just fascinated with science and innovation.
He was kind of on a mission to modernize his country and searched for looking for someone to care for his kids. He hired Anna, who was a schoolteacher, and through her really increased the knowledge and the innovation throughout the country. So, we saw that as a corollary to the which, you know, might not seem so apparent to everybody, but sometimes we make a stretch.
But in our version, we thought that FDA played a corollary to the King because FDA was wanting to use new technologies and modernize the submission process.
How they are achieving that one way, at least, is through the eSTAR program. So, we think of the eSTAR program as playing the part of Anna, the schoolteacher.
When we started going out and talking about it, we decided to capitalize on the headline song from the musical, which I don't know if you guys all want to sing it, but getting to know you getting to know all about you getting to like you getting to hope you like me maybe we'll put.
Etienne Nichols: A link to the song.
Lisa Pritchard: We could do that for sure.
And so, we used the getting to know you as just kind of introducing the basics of the eSTAR program and then the getting to know all about you as kind of diving into it, how to actually use it, getting to like you, how to achieve the advocacy in your submission, how to really make the eSTAR work for you.
And then the Getting to Hope You Like Me was the final part after you submit it, hoping that FDA is going to like what you put together and kind of what to understand from the review process.
So that's kind of how we came up with the concept of the eSTAR and I. For us, it just kind of creates a fun way to talk about the program.
For me, personally, I am secretly hoping that my parents, who were both active in community musical theater, are looking down and maybe smirking that their introverted engineer daughter, who would never be caught dead in a musical, is able to communicate in this mechanism absolutely.
Etienne Nichols: Well, and now you're on a podcast.
Lisa Pritchard: So, hundreds of people yeah, don't tell me that.
Etienne Nichols: Well, we'll definitely put a link in the show notes to Your client alerts, because I think those are very valuable, even on I mean, there's lots of different I don't know if you have 30 or 40, it seemed like last time I looked at your website.
I'm not sure how many you have, but those are I'm not sure how.
Lisa Pritchard: Many we have either, but there are a lot of them and on a lot of key topics. Another real popular one is our 510K series, and our pre-sub series are kind of must reads for regulatory people.
Etienne Nichols: Yeah, okay. So that's kind of the history of how you came up with the idea of eSTAR and I. But let's talk about eSTAR itself, what's the history of eSTAR and maybe what prompted it, how it came about. And maybe I'd look to you, Patrick, or whoever wants to jump in on this one.
Patrick Axtell: Yeah, I can handle that one.
It's kind of two parts. The history is more of the how it came about to be, the way it is, why a PDF, why it's not in some other format like eCTD or a web form.
And that story has kind of an internal and external story that leads up to it. But the other part about what prompted is kind of more the why? Why do we make it?
And so, I'll focus on that first and let me know if you want me to go describe the how afterwards. But the why is really the same reason why we had to make internal Smart templates for reviewers.
First off, we wanted to make sure that the submissions were comprehensive and that they were getting fully reviewed. So, we wanted to make sure that the submission contained all the information it needed to ensure that the device was safe and did not adversely affect public health.
There's also the automation aspect where there's a whole lot in the submission preparation process as well as the review process that we knew we could automate with these types of templates.
And so, we did that. And so, there's a lot of benefit there to saving time both by the applicant and the reviewer.
There are also these internal guides that walk the applicant through the process of completing different sections like biocompatibility and EMC and so on. And those sections help the applicant know what needs to be provided and it also guides the reviewer on reviewing that content.
And what those guides also do is it's interpreting our policies, our guidance and regs for both the applicant and the reviewer so that they're interpreting them the same way and not misinterpreting or doing it differently, which happened in the past.
So, there's that benefit as well. There's also the standardization of the structure, so you get a more standardized submission, and you also have a more standardized review template. And so standardized submission means that the reviewer can quickly find information in that submission because everything's placed the same way in every submission.
And I can tell you as an ex-reviewer, the thing that took the most time was simply finding different information that you're looking for in a submission, since it could be formatted in all sorts of different ways.
A table of contents has actually never been required in a submission. I got submissions that didn't have it made. It pretty complex. It's also a benefit for the review template to be standardized because future reviewers can then go back and quickly find information in those review templates as well.
Also, when you have templates for both applicants and reviewers, they complement each other. All the questions in eSTAR complement and match the questions that are in the smart template. So, the reviewer is getting what they're expecting, and the applicant knows that they're providing what the reviewer is expecting.
So, there's that benefit as well. And there are other benefits I won't go into, and there's some that have not actually been realized yet. For example, all the benefits that come with structured data. We're getting all this structured data in eSTAR. There's all sorts of things we can do with that that we haven't been able to do just yet, and we're working on that.
For example, automating the login process right now with eSTAR and e copies that come in your submission. It comes in and someone's actually transcribing all the information manually from your submission, typing it into a tracking system.
They're taking the documents and they're packaging them, they're converting them, they're doing all this manual processing and such. With the structured data, we can automate that whole process. And that provides a whole lot of benefits in the sense that if you're trying to provide a document at the very end of the review, and it's pretty big, you can't provide that over email. We don't have access to Box and Google Docs and that becomes difficult if it's too large to send it over email with this system.
Since if we can automate the login process, that speeds up that process. And so, with the CDRH portal where you submit electronically, we can make it potentially such that once you submit on the portal, the reviewer gets that, whatever it is, whatever size.
And there are other benefits as well with structured data, for example, we could automate the 510(k) summary. For example, we collect all the Five to K Summary information in eSTAR, in structured fields that correlate with regulation 8792, we could collect all those in structured and put those on the right.
Now on the we post the 510(k) summary document and the indications for use document, and those aren't really searchable. What you can do with this is if you're posting the structured data on the 510(k) site, indications for use is now there in a structured format.
So are all the parts of the 510(k) summary, like for example, the technology comparison summary. And so, all those fields can now be searchable by applicants as well, providing that big benefit, not only the automation aspect that's there too.
And then of course, the reviewer doesn't have to worry about extracting the 510(k) summary or the Indications for use and packaging it up. That all goes away. So, there's all sorts of ways we can simplify and make the process much more efficient with what we're doing with eSTAR.
And as a reviewer, I would have loved to have had something like eSTAR, having a structured format like that, that's standardized, that matches my template. It was talked about back when I was a reviewer about wanting something like this. And I think it's great we now actually have something that's working for us.
Etienne Nichols: That’s cool, and I'm glad whoever is putting this together well, such as yourself, has that experience as a reviewer too. I think that's really cool and I think that speaks to the value that it's going to bring.
While you were talking, there was a rabbit trail that I kind of thought about, and I didn't necessarily prep this question for you guys, it just popped in my head.
I know there's been an executive order on AI and driving that down through the system. Is that a potential use of AI? It seems like this could be a good use case.
I don't know if that's been talked about or thought about yet and feel free to punt. This wasn't.
Patrick Axtell: No need to punt. So, in order to first catch with how the government works, we need what's called an ATO and authority to operate for any software. And so, we haven't been able to get access to any AI applications yet.
We cannot provide our internal proprietary information to an AI that would be very they have I think Microsoft's got an AI set up that's specifically for government use, that it's for private use.
We haven't been able to get access to that yet. But we do have lots and lots of ideas for what we can use AI for beyond eSTAR. Mostly it's for the reviews.
So, using it for looking at the deficiencies and doing things there, there's all sorts of different uses, but we got to play with it first to be able to know what actually will work and what actually will not work.
Etienne Nichols: Yeah, for sure. So maybe another question that I'm curious about is how's the industry received eSTAR.
It seems like anytime something new comes along, people are going to complain about it, people are going to finally begrudgingly use it and then maybe they love it. But I'm curious how this has been received.
I know Kathy and Lisa, you said you've been using it for a long time. Early adopters.
Patrick Axtell: Can you speak to know?
Kathy Herzog: I think it's hard to know the whole pulse of the industry. Our experience in working with clients in the industry know they're allowing us to take the lead because we're contracted to prepare submissions for them, but we're educating them along the way.
I do think to the extent that the eSTAR is now standardized, like Patrick was mentioning, and the fact that there's a lot of embedded help within the template. So, if you are confused on a topic, I find the help section to be really meaningful.
It will sometimes clarify like, I'm not really sure how to answer this question.
Usually, the Help button provides an additional level of information. So, I think it can help. Maybe companies who are not as familiar with 510 K's feel more confident that they're supplying all the necessary information and have a little more insight as to am I doing this correctly?
It doesn't still change the fact that you need to have a full data set, you need to write clearly and articulately, you need to present your best package. You still have a lot of writing behind the scenes, but in terms of taking some of the guesswork out of hey, is this submission complete? Am I at risk of a refuse to accept? I think the eSTAR has gone a long way to provide increased confidence with the industry.
Etienne Nichols: Maybe if I ask one question deeper, are there any strategies? Because you mentioned that Help button and things that they can get in. I'd like to maybe hear both sides. So, Kathy and Lisa, any strategies you recommend?
And being able to do this well. And maybe from Patrick, some things that maybe you've seen companies not do well, or maybe they've abused it in a certain way. I don't know who wants to go.
Lisa Pritchard: First, but I could take a start at some of those strategies.
The one thing that you mentioned about maybe people being apprehensive about it and then kind of adopting it, I definitely fall into that camp that when FDA first came out with the concept of eSTAR, and we heard that it was coming down the pike.
Patrick, maybe you want to cover your ears for this. But I was super apprehensive about it. I kind of was thinking that it was a mechanism for FDA maybe to overreach in controlling how the submissions were prepared.
And so, it kind of was a hurdle for me to get over to actually become an adopter of it. And I think it's a real testimony to the work that they put into designing the templates that now I really am a big fan of it, and I agree with Kathy that all of the help features that are in it go a long way towards that.
And one thing that we noticed is in the help features, if you follow those, you probably are able to eliminate 50%, if not more, of the common deficiencies that we routinely would see people coming to us with and saying, help us resolve these, because the requests in those help boxes point them out to you.
So, if you use those to your advantage and that's one of my key strategies, is to always use those help boxes.
I like to use them as kind of a QC check before I do a submission. Just make sure, did I address everything that's in there?
And even though I've been doing it over 30 years, doing submissions over 30 years, I still always open those help boxes because every submission is unique. So, each time I want to know what is it that I need to put in there?
The other thing that I strongly recommend is that you begin at the beginning of the template. So don't kind of jump around as you're creating it, because since it is an interactive PDF, and Patrick could talk more about that, but if you jump around, I think you're just far more likely to miss something and have the template not populate or not show you a section that you need to complete.
For instance, if you missed identifying that your product has software, you're not going to even see the software sections of the template to be able to complete, and you could get yourself in trouble that way.
So just working from the beginning works really well.
I think one of the challenges that we've had to overcome is how do you organize it to be able to work with your internal review teams?
So, one of the strategies that I like to use is I create a version of the proposed text fields and the attachments. I create like word versions of those and work with them outside of the template with the internal review teams so that we can track the changes that everybody's making before we get to the final content, just because it's really difficult to do that just within the PDF version.
I think another one I would be reticent not to mention is eSTAR is very well designed to provide the evidence that's required in a submission.
The interaction with all of the guidance documents is kind of mind blowing when you go out to the FDA guidance document database, there are just so many of them out there that I think is a big challenge for industry to understand what applies to your products.
So, it does a great job of that, but people need to understand that it does not include anything about advocacy in the template and rightfully so. I don't think that it could, although I think if anybody could figure it out Patrick would.
Etienne Nichols: I actually want to ask you, having not delved really deeply into eSTAR, I've looked at and actually I have in front of me just kind of looking at the COVID here, how does that interaction with guidance documents work? Can you kind of walk me through that a little bit?
Lisa Pritchard: Patrick, do you want to do that?
Patrick Axtell: Yeah, I can do.
Kathy Herzog: So.
Patrick Axtell: First off, it's not just guidance documents is built into it, we've built in a lot of IMDRF documents into it as well as far as the attachments go and I can talk about the history on how Eastrock came about to be, the way it is in a PDF and so on if you would like later.
But when it comes to the guidance documents, we build those in as the guides. So, you have like the reprocessing guidance document. You have software, EMC, wireless labeling. You got all these different guidance documents.
And we built these in as different sections. And so, each guidance has been constructed as this guide that I was referring to earlier, and it walks you through what the guidance document is requesting that you provide.
And then there's all sorts of other guidance documents that get built in as maybe a single question or maybe sometimes just help. Text.
We struggle to try to keep the burden and the number of questions in eSTAR and our internal review templates since they correlate to a bare minimum as much as possible, focusing on only what is absolutely needed.
And so those questions are basically what we think are what is absolutely needed the bare minimum for that standard or that guidance to fulfill the requirements and recommendations of that guidance.
Does that make sense?
Etienne Nichols: Yeah, that's great. Very cool.
And Lisa, I kind of cut you off so I didn't know if you wanted to continue on with your best practices and strategies and tips.
Lisa Pritchard: No, not a problem.
Kathy Herzog: At mean the one thing that I.
Lisa Pritchard: Wanted to expand on a little bit was the building advocacy into the submission. And Patrick will probably smirk at this one because we bring it up every single time is we feel at DuVal & Associates that the executive summary needs to be considered a mandatory part of the submission that is central to creating your submission in a way that's telling a story.
So, you are conveying to FDA, to the review team about what your product is, why it's important, why the information that you presented in the submission is there, and why it is sufficient to reach the regulatory decision that they need to ponder.
And in a non-eSTAR submission, we always used the executive summary as kind of a key piece of that, of introducing the story. And in the eSTAR we also do that, but in the template, it is an optional attachment buried at the end of the template within the administrative documents.
And so, it's not a natural starting place.
So, we recommend, don't consider it optional, but consider it mandatory. And then for the strategy on that, to make it work with eSTAR is reference that in your cover letter so that the review team, the management, know that it's there and don't just come to it at the conclusion.
Of the review, but that they recognize that it's there and can be used kind of as a starting point to give them a nice foundation on what they're going to read.
And then I think the last thing that I was going to say for a strategy is just you're going to have questions come up as you start using the eSTAR templates and there are so many help features available to you.
I think the first place that I like to go when I come into something that doesn't quite make sense is go to the FAQ that is built into the template.
And a lot of times that will answer the questions if it doesn't. The FDA has a really nice webpage for the eSTAR program, and often you can get the responses there and then sort of as a last resort, is reaching out to the eSTAR staff. And I know people sometimes are hesitant to do that, but I think that was probably instrumental in getting me converted to eSTAR, is when I was having very early questions and I reached out to the eSTAR staff, they were so phenomenal in their responses, they were so quick to respond and thorough provided very helpful input.
You could see over time as the new versions of eSTAR came out, they're working really hard to address the little kinks that invariably come up with something kind of this just I can't say enough about Patrick and Etienne.
Etienne Nichols: That's very cool. And Patrick, I don't know if you want to speak to or even Kathy, some of the pitfalls that you've seen companies get. I don't know if it's possible to abuse it, having not, again, not used it extensively myself.
If you've seen any of those types of activities where, well, they should have used it differently, or is it built in such a way that it's almost pokey oaked, I don't know if you want to speak to that.
Kathy Herzog: The key with eSTAR is eSTAR? You just have to get started. You got to get familiar with the template. You got to play around with it, exercise all the radio buttons, the pull-down menus, explore the entire template, even if some fields are not applicable to your media project because they might be in the future.
And it's good to know the whole range of information that may be requested at some point for your device within the eSTAR. So first, explore the template. Second, to Lisa's point on best practices, set up a folder structure offline that parallels the section flow that's going to apply to your device.
Build your documents within those folders.
Review those as a team. The very last thing that I do is populate the eSTAR. I mean, I made the mistake at first of populating as I went, but then you're constantly trading out attachments.
So, I learned that you need to really build the entire content offline. And the day of submission, I actually populate it, and I have a folder of all the master attachments in the order that they'll be attached, and you just start populating the template.
So that kind of was a reverse of my thinking. With E copy you build as you go. With eSTAR, you build it off the line and then populate the template.
Good advice. Naming the attachments is important, I think, on the navigation pane in Adobe, when you open the attachment pane, you can change how it's shown. I think it defaults to alphabetical order. If you want to force attachments in a certain order, then you'd want to put a numerical prefix in front of your file name.
That's another way to bump the executive summary to the top. Put it as like a one or an A. You can also organize them by section.
Patrick, I'm going to put a plug in that it would be really nice if eSTAR counted attachments by section and in total so that we can compare that to our master attachment list and know for sure that every document we intended to attach has found its way to the template.
Otherwise, right now I'm manually counting to make sure, like, if I have 50 attachments, that all 50 find their way to eSTAR because there's not an account, you have to do that manually.
So that's just a personal plug. Because one time I missed an attachment. Not intentionally, but we thought we had it in there and we didn't.
Etienne Nichols: If I could do just an interjection there. If people do have comments or thoughts, maybe not everybody has a direct line to Patrick like you and Lisa do. What are the thoughts or what are the recommendations or ways.
You can comment or suggest improvements.
Patrick Axtell: Patrick I can take that one. Yeah. So, their method of getting to me and my team is the same as everyone else. So, we have an email address in there which is esubmitter@fda.hhs.gov.
It's in the eSTAR template at the top. It's on the website.
We know it's no longer a pilot. We're looking to try to have a forum instead of an email address where just like online forums, you can go type in questions and then search for other people's questions and get your information that way.
And then we would man that forum. We're trying to get something like that. It's in development right now. It's going to go out for internal use only at first.
But yeah, just email the east of Pilot email address and we're right there. I'm reading those. My team's reading those. My team is, as Lisa said, very responsive. We're a great team and typically respond within minutes.
And I was getting back to one of your previous questions, if I can quickly go on to that, is the missteps that applicants take.
So, from my perspective, based on the questions that we get in the inbox, the huge majority of missteps involve not reading the eSTAR web page, not reading the help text or the directions in eSTAR, especially the FAQ that Lisa mentioned.
The huge majority of questions would be resolved if applicants just read the website and the content in eSTAR. And so, I highly recommend that folks do that in their first time, and I think that would address the huge majority of their concerns.
Etienne Nichols: Okay, cool.
Lisa Pritchard: Another one I just wanted to put in there for when might be a good time to reach out to Patrick and his team is sometimes within the FDA review process; the reviewers are not always applying eSTAR the way it's intended to be.
So, one example I had from somebody who was a reviewer that was trying to apply a refuse to accept policy to mean they were doing it incorrectly in the first place.
But also, East Air is not supposed to have the RTA. That is one of the key advantages of it. There's a technical screening review that Patrick probably talk about more, but not the RTA.
And more recently had one where a client had used the automatic 510(k) summary generation feature and then the reviewers wanted to change the way the information was presented in there and include a table of comparing the substantial equivalence.
Information which can't really be done because the automated 510(k) summary is populated by the text boxes in Esar which don't have any formatting abilities.
But when you're talking about the 510(k) summary, you're right at the end of the review process. And so, people are probably more inclined just to jump through the hoops that the reviewer wants to get their clearance.
But that definitely is something that Patrick and his team should be aware of if nothing else, just for training within FDA to make sure that the review process goes as it's supposed to.
Etienne Nichols: Okay. No, that's really good feedback. And we'll put Patrick's email so that he doesn't have to take notes and remember during this podcast. But we'll be sure if anybody has comments, they can feel free to email his team.
Kathy, I kind of cut you off a little bit. You were giving some really good advice on submitting or filling out the eSTAR template. Did you have any other thoughts or comments about that?
Kathy Herzog: I would definitely take the time with your team to walk through the template, especially if it might be your first eSTAR, and get the project team, who's the primary contributors of the information, familiar with the requested content, and then work offline, as we mentioned, create a folder structure that's parallel to the sections that are applicable. Build your content offline. Vet it offline because it's very difficult once it's attached or you have information in text boxes to modify it within the eSTAR, it's just more cumbersome and then you can't track changes.
So as the submitter, you want to have absolute faith that the information you're putting in there is what you intend. So, if there has been a change and you weren't aware of it, you don't want that to happen.
If it does, take a little bit getting used to. Before eSTAR was mandatory, we had a couple of submissions where we started writing e copy and then converted to eSTAR.
That did not work well because eSTAR is written differently. It's just how the information is provided is chopped up differently.
It's also harder when you have a global change. Let's say you decide you're going to change the name of your device, and every document is affected. It's much harder to do a global edit.
And I don't know, Patrick, if you have any tips on that, but otherwise you have to go into every single individual attachment and make a change. Whereas in e days gone by, that might be a continuous document that you could just do one global search and find and replace.
So, there are some things that you've got to really know your document. You got to really know how the attachments the content relates to each other. So, if you change something in attachment one, does it affect something in attachment two?
So, you really do need to understand the connectedness of the information in your submission because you can't do that global seek and find.
Etienne Nichols: Very cool. Patrick, I didn't know if you wanted to comment.
Patrick Axtell: Sure, right. Just like with know you have multiple attachments, if you wanted to change the name of your device, you'd have to go through and do a search for each of those attachments and changing in each of those.
I think that applies for e-copy the same it would for eSTAR, since eSTAR has several attachment places like a device description and labeling and so on.
As far as within the eSTAR itself, though, if you change the device name right at the top of the device description section, that change will auto populate all the places that device name exists throughout the template, like the 510(k) summary in the Indications for use form and everything.
So, we try to automate it. So, you only make one change. It applies to everything, but again, within the attachments can't do that.
There is a place if you have attachments in eSTAR. If you've already attached them, there is a search in the attachment pane where you can do a search, and it'll tell you exactly what attachment and where.
A certain term, you know. Be sure you can use that as well to find things within all your attachments, if you'd like.
Etienne Nichols: Okay, great. Lisa had mentioned something about the technical review versus RTA. I wonder if you would like to speak to that as well.
Patrick Axtell: Sure, right. So, with ecopy, before you start, we had our RTA guidance documents, and it involved this long checklist that applicants would go through, and reviewers would go through when they received the submission, and the reviewer would go and check to make sure all these different aspects were provided.
And eSTAR has automated that. And as long as the responses in eSTAR are accurate, meaning if it's electrical device, they say yes, it's electrical, which enables the EMC section and other sections, and if they say yes, it's got software, it actually has software and so on, as long as they answer those responses accurately and the attachments are relevant.
So, when you're providing a device description attachment that includes what that question is asking for, make sure that your attachment actually is the device description attachment and includes that information.
So as long as you provide accurate responses and relevant attachments, we can be sure that that submission is complete, comprehensive, does everything it needs to do.
Couldn't do that with ecopy, right, because it's manually constructed. So that's why we have the RTA checklist.
And so, with eSTAR we don't have RTA and so the clock is not going to get reset as often with eSTARs because of that. And so that has been a big difficulty for reviewers because they have relied on that RTA, the ability to reset a clock.
I can tell you that reviewers actually would typically prefer to have a submission that came in as an ecopy that had maybe a couple missing things so they could then put it on an RTA hold, because that resets the clock and gives them more time to actually look at that submission because they can then go back and review all the other sections that were actually complete and then get ahead of themselves on this submission.
That's no longer possible with eSTAR. And that's been, I think, the one big drawback for reviewers when it comes to eSTAR is that lack of RTA, that inability to really put things on reset the clock as often as they used to do.
Etienne Nichols: I appreciate the transparency. Hopefully it will help the industry start putting in a little bit more complete submissions, at the very least.
Yeah, that makes sense.
I should have asked this question at the very beginning, and I don't know who wants to answer it, but who should be using eSTAR now?
Lisa Pritchard: Anybody that is submitting a 510(k) has to be using eSTAR now. I mean, 510(k)s are the vast majority of the submissions that go into FDA. Close to everybody needs to be using it now.
eSTAR is voluntary right now for de novo submissions, which are, I'll say, rapidly increasing, I think partly because of the speed of innovation and finding a good Predicate device is getting more challenging and it's not yet available, at least for general public, for PMA devices.
I think Patrick could speak to where eSTAR will be going in the future, but for right now, everybody that's submitting a 510(k) needs to be using eSTAR.
There's also a beta version for pre-subs right now that I think pretty cleverly. They termed pre-star.
Etienne Nichols: I like that.
Lisa Pritchard: Honestly. I think that one needs a bit of work but look forward to that one evolving just like eSTAR has.
Etienne Nichols: Okay, we'll have to talk about that on another episode. Maybe we can in the last few minutes that we have, I would like to hear maybe where we're going. If you could give a preview of maybe eSTAR's coming attractions.
I was looking at the template, and I saw the grayed-out pre-market application or PMA section. So maybe start there or Patrick or whoever wants to add something about the future.
Patrick Axtell: Right, so that is coming very soon.
PMA content. The PMA content will include PMA originals, 180 days real times and panel tracks.
And the next update, which will be version 5.0, will also include the Cybersecurity Guide, which we've been getting requests for and has been delayed for reasons I won't get into very soon in the new year, maybe late January, depending on how things work. We got a little bit of delay with 513 G. So, the pre-star that Lisa was mentioning, and I'd like to get your input, Lisa, on what you think we could do to improve the pre-sub content.
But we're going to be adding 513 G to that pre-star as well. And then eventually down the road, we'll be adding other Q Sub types to the pre-star and then also eventually IDE originals, and then after that their supplement types, because we got a whole bunch of different IDE supplement types.
Those IDE supplements will be the last thing that gets added into eSTAR. Maybe one day, maybe not. We'll add HDES, but we'll see if we get enough pressure. Maybe we'll do that, but that's basically where we're going. And then of course, we got the international pilot with Health Canada. We're looking at adding another jurisdiction or two.
So that's coming as well down the road. We'll see how that's going. We're in that pilot with Health Canada getting the feedback from the applicants in that right now. So, we got to make the changes for that.
Add IVD into the international spectrum as well. Right now, international pilot is only for non IVD eSTAR. So, there's a lot of things coming down the road. But yeah, very soon PMA, very soon cybersecurity and not too much later.
513 G right now.
Etienne Nichols: Very cool. Really appreciate all the work you're doing on this and I'm excited to see what the future looks like in the last few minutes that we have. I don't know if we wanted to do a quick round robin.
If you have any last comments or tips or recommendations for the listeners kind of as we close out, maybe we could start with you, Kathy.
Kathy Herzog: Like I mentioned earlier, there's always a first eSTAR you're going to do, so it truly is an eSTAR, so no substitute for just getting started. Even if you don't have an immediate 510(k) on your horizon, to gain familiarity and to be able to advise your internal project teams is really helpful.
So, if you haven't had a chance, download the template. They're free to do so and then just start exercising and recognizing how you're going to have to rethink your design and delivery of the content within the eSTAR framework.
Etienne Nichols: I always like the FDA acronyms, but the puns are even better today. eSTAR and pre-star. This is really cool. Lisa, what about.
Lisa Pritchard: Mean? I think the things I'd like to emphasize is just don't forget to include the advocacy in your eSTAR submission. And so, start with that executive summary. Build the advocacy through all of your attachments and use those built in help features to help with the QC process of the submission to make sure that you've got all of the information in there to successfully avoid the deficiency questions.
Because when we've seen eSTARs done right, we've seen a drastic reduction in the review time and the number of questions issued. So big benefits to be gained there.
Etienne Nichols: That's awesome to hear. Patrick, do you want to round us out?
Patrick Axtell: Sure.
My big thing is just please feel free to reach out to us at the email address I mentioned earlier. Any suggestions, feedback, please email us those things. If you're having problems with something, please let us know.
And that's the main thing I want to say. And if you have questions like we said earlier, be sure. Read the website, read the FAQ, read in the help text.
If you still have a question, please feel free to reach out to us as well.
Etienne Nichols: About that great. Thank you all for coming on the podcast. Those of you been listening you've been listening to the Global Medical Device Podcast. We'll include those links in the show notes, so be sure to check that out and we will see you all next time, everybody.
Take care.
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