Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k).

Since the FDA will refuse to accept submissions that are missing the appropriate documentation, it’s vital to understand what this is and when it is needed.

Today’s guest, Allison Komiyama, PhD, RAC, is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation.

She started her consulting practice, AcKnowledge Regulatory Strategies, in order to serve clients all over the world, large and small, who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley.

In this episode Jon and Allison have a very insightful conversation on the 510(k) submission process with lots of actionable insights.

Listen Now:

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Some highlights of this episode include:

• What happens to new submissions at the FDA, and where the 510(k) fits in

• The “Refuse to Accept” policy: What it means and how it can be a positive thing

• Where the FDA stands on “I promise” statements

• Advice for companies using materials that require biocompatibility testing

• Tips for design controls and 510(k)

• Biggest mistakes that Allison has seen with 510(k) documents

• The timeframe for getting your 510(k) through the FDA, and what factors it depends on

Links:

Allison on LinkedIn

Acknowledge Regulatory Strategies

Premarket Notification Acceptance Checklists for 510(k)

FDA 510(k) database

FDA Guidance for ISO 10993-1

Information on De Novo Summaries

Memorable quotes by Allison Komiyama:

“You don’t want to ask for forgiveness instead of permission. You want to play by the rules.”

“My recommendation is to include that RTA checklist... That really saves some time.”

Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical-device experts and companies.

Jon Speer: Okay. I have a pop quiz for you. Do you know what happens on September the 24th, 2016? Well, if you're a medical device company in the United States with Class II products, you need to know about September the 24th, 2016. Why? That's the date when your UDI submissions are due to the FDA for all Class II medical devices. Folks, it's happening in a very short period of time from now. And there's a lot of work that you're gonna need to do. And you need to know all sorts of information to be able to submit your UDI information to FDA on time. And that's why on today's episode of The Global Medical Device Podcast, I have as a guest Gary Saner. Gary is with Reed Tech and Reed Tech is one of the best experts in the space of UDI, and they can help you solve all of those needs on time, ahead of time. In the notes to this podcast, I also have links for you, for the Reed Tech Class II Submissions Guide e-book, as well as the Reed Tech data elements chart. Be sure to check those links out, and be sure to listen to my conversation with Gary Saner of Reed Tech on this episode of the Global Medical Device Podcast.

Jon Speer: Hello, this is Jon Speer, the Founder and VP of Quality and Regulatory at Greenlight.guru, and welcome to another episode of the Global Medical Device Podcast. Ladies and gentlemen, there's a hot topic in the medical-device industry right now. It is quickly approaching and that topic is UDI. Well, the good news is we have an expert on today's podcast. We have Gary Saner. Gary is the senior manager of Information Solutions in the Reed Tech Life Sciences group. He's a subject matter expert on UDI, and other structured content submissions to regulatory agencies. Gary has over a decade of experience in the life-sciences industry and has worked for over 30 years in areas of software development, process management, and data conversion. Gary is an active member of the HL7 SPL working groups and co-chairs the HL7 technical team. He is a frequent presenter at industry conferences for regulatory of the life sciences professionals. He holds a bachelor's degree in mechanical engineering from LeTourneau University with graduate studies in Computer Science and Statistics at Villanova University. Gary, welcome to the Global Medical Device Podcast.

Gary Saner: Jon, so happy to be here. It's gonna be a good discussion about UDI, and thank you so much for the invite to participate.

Jon Speer: Oh, you're welcome. I've had a chance to hear you speak a couple of times on webinars, and we had a chance to meet a few weeks back at 10X, and you scared me a little bit. The reason you scared me is you reminded me of this important date that's coming up. And I'm sure we're gonna get into it here in a moment. So why don't you give our audience a little bit of background of UDI. What is it? What does it mean? Why should I care?

Gary Saner: Yeah, that's a good place to start. Going back to, actually, 2007, there's a couple FDA Amendments Act that laid some groundwork for this particular activity. And then in 2012, there was another Act put forth where it identifies the FDA Safety and Innovation Act. Both of those laid the groundwork for a UDI. And in September 24 of 2013, the FDA responded to that and finally issued a UDI final rule to the Code of Federal Regulations. And basically, that rule said you need to... Medical device labelers that distribute products here in the US, need to identify their products with something called a unique device identifier. And then simultaneously, that same mandate said the FDA is gonna start collecting information and attributes about that product, and put it into a database, and make that available. So they talked about a timing, a year out from that September 2013 release, where the implementation would begin in 2014 and actually run through 2020 before all the activities would be hitting the deadline.

Gary Saner: We're two years into that compliance timeframe. And the objective from the FDA was to provide a standard granular identification of medical devices. And at that point in time, there wasn't anything available along that lines. There was a lot of proprietary identification, and the FDA wanted to basically reduce medical errors, and make the adverse-event reporting much more accurate, provide medical-device recalls with improved accuracy, and basically improve the patient's experience. Before we go too far, the definition of that UDI has two parts. And as you know, we've talked about this where it includes a device identifier and a production identifier. So that device identifier identifies the labeler, and the product and, as necessary, a production identifier includes the information about a serial number or a batch number. And that number, that identifier, needs to appear on a label and also needs to be reported to the FDA. That's the quick summary, Jon.

Jon Speer: Yeah. No, I appreciate that. And what I heard from what you just described, is this is really all about me as a healthcare consumer, giving me some further assurance, or guidance, or direction that this is all about, it's all driven about making sure our devices are safe, that there's any information in the adverse events that are happening about the products out there that really FDA and other regulatory bodies have a means to be able to track and trend those types of events.

Gary Saner: Yeah, absolutely. There is an analog in the pharmaceutical arena where you have an NDC number, National Drug Code identifier, and that's universal for products in the US. But there wasn't anything like that for devices, and this is why it's so significant for the device arena.

Jon Speer: Right. It feels like one of those "who moved my cheese?" kinda moments [chuckle] that I haven't put down. And I'm sure you've been very busy. You mentioned that this really started to hit med device companies back a couple years ago. Talk about that. We're a couple years into this process, and there's a critical timeline. It's a critical date thats coming up here in a few months, in September of 2016. Give us a brief rundown of what's happening from 2014 to 2015, and this other deadline that's coming up on us here in just a few short months. Talk about who should be concerned about that and why.

Gary Saner: Yeah. There's a couple deadlines that have taken place. The implementation was based on risk of the particular product, so Class III labelers needed to submit their device data and change their labels by September 2014. And then this past September, in 2015, the implants, life-sustaining, life supporting products needed, again, to update their labels and report the data to the GUDID. This September, to be honest with you, and I don't mean to scare you, but we only have 78 working days left. [laughter] But this September, those Class II manufacturers need to make those label changes and get their records into the FDA. Some of the challenges, by the way, are not only the time is very tight, but there's higher number of companies being involved in this deadline and a much higher number of submissions. We expect another 400,000 records to be added to what the database has today. There's a lot of activity. And those Class II labelers should be well underway. We know of some that are just now getting started, but good news is it's not transpired to the point where they're late yet.

Jon Speer: Right.

Gary Saner: The bad news is, time is running out.

Jon Speer: Right, right. And I'm sure we're gonna talk a little bit about that in a moment, about that timeline that's ticking. 78 days at the time of recording. By the time this podcast goes live, Gary, it'll be less than that. Time definitely is ticking.

Gary Saner: Yeah, without a doubt. I was just gonna mention that for those Class II labelers that need additional information and so on, I believe your site, as well as our site, will have a Class II submissions guide e-book available to help those labelers come through and read about it and get some more information.

Jon Speer: Absolutely. Well, Gary, we'll be sure to send that out to our listening audience and even those who might not even be listening, so that they are aware of this information that's coming to a regulatory body, an FDA office near them. That deadline, again, is September 24th, 2016. Talk about some of the challenges that are involved with that. Do you think that big companies are better equipped for this than smaller companies, can you talk a little bit about that? Talk about some of the companies that B-Tech works with on these types of initiatives.

Gary Saner: Yeah, our solution, actually, is a tool and a service we offered in both particular modes, and we're able to scale that down to very small companies. We actually have some clients that have one submission, and they're very much interested in the expertise that we can offer and being able to hold their hand and walk them through this. And yet, on the other hand, you definitely want to have a lot of submissions and spin it in electronic format, so we'll talk a little bit more about that later, perhaps, but there's a number of organizations that will need to respond. We have seen Class II companies, typically with less staff. A larger company might have Class III devices and they've kinda walked through this submission process already and have a solution in place. But for those new Class II companies, less staff in the regulatory arena makes it difficult, and then they have to put together a solution, whether it's small or large, and that task is pretty daunting.

Jon Speer: Right, right. And I can imagine... I remember when you had spoke at Tenex a few weeks back, I can imagine that you anticipate, as we get closer and closer to that deadline, that there could be some... Oh, what's the right word? I wanna say delays, or things are gonna get clogged pretty quickly 'cause it's all basically... It's going through a single choke point called the FDA.

Gary Saner: Yeah, exactly. There's a lot more companies involved, so the number of questions that we expect the FDA helpdesk to field go up, as well as the actual data submissions. There was some delays in response by the FDA last deadline, in September, where acknowledgement coming back from the FDA for an electronic submission would normally take about 12 minutes, but with the workload, it turned into be three days. That last week was really intense. The bottom line is those Class II labelers ought to try submit as early as possible and try to get some of this out of the way.

Jon Speer: 'Cause we know there are a way more Class II devices in the United States than there are Class III. If there were some delays in the Class III, we can surely anticipate that if you're not on the ball, you're gonna see the same sort of thing here come mid to late September.

Gary Saner: Yep, absolutely. We expect, actually, over twice the number of volume submissions of this round than in the previous round.

Jon Speer: Sure. Let's talk a little bit about that UDI process. Reed Tech's gonna work some magic, but really, your magic is all about knowing... I'm not trivializing this by any stretch, believe me. But it's all about knowing what information to capture, and how to communicate that to the FDA and get that imported into the FDA database. Can you talk a little bit more about that submission, and what that process is, and what kind of data is gonna be provided as part of that submission?

Gary Saner: Yeah, that's a good discussion. The number of fields that need to be submitted to the FDA are 55 in total. And then the FDA derives seven additional data fields; so a grand total of 62 fields are actually stored in the database. And the various categories include product identification; information about the labeler; the organization; in this case, the manufacturer, in many cases; regulatory information; packaging information; production control; and there's a number of other characteristics about the product that need to be gathered. And again, I'll mention a Reed Tech data elements chart that we have available to identify these items and start to work your way through and go through a check list, see what items you have readily available. In some cases, you'll have them. We have seen some fields are somewhat difficult to come by. Digging up the GMDN code, for example, or finding the Dunn and Bradstreet number for your company.

Gary Saner: In some cases, you'll find information about a single use might be showing up on a label template as a graphical icon, but not anywhere as an electronic data value. It does take some work, and across many departments. It spans regulatory, operations, in some cases IT, and other departments to get this data collected.

Jon Speer: Right, and now you mentioned something that I've had some experience with: GMDN codes. Does Reed Tech help companies acquire GMDN codes? Or tracking that if you don't know what they are?

Gary Saner: There's actually two data values that are related to the GMDN code. One is the actual GMDN code, The Global Medical Device Nomenclature code from the company that maintains that database, and that's a subscription. The FDA also offers a free alternative, which is a four-letter code that the FDA put together. The actual definitions are the same. We help clients find those particular databases and obviously they need to pick the one that's most appropriate for your product. But, yeah, we do offer a lot of Q and A, and helping and consulting to get this data set collected.

Jon Speer: Right, because your mission is, of course, to help companies meet the impending UDI requirements from the FDA. And I can imagine there's a lot of, excuse the expression, but hand holding, and guidance, and direction that you're following along the way, because you're the only expert that I've come across when it comes to UDI. I don't know this, and any time somebody asks me a question about UDI, and I, "You need to talk to Gary at Reed Tech. He's the man."

Gary Saner: Thanks for the recommendation there.

Jon Speer: Oh, absolutely, absolutely. So when it comes to making that actual submission of the UDI data to the FDA, can you talk a little about how that actually happens?

Gary Saner: Sure, there's two basic methods that the FDA has created. One is something called the FDA GUDID web interface. Now, the GUDID... I don't know if we've actually defined that.

Jon Speer: And when you say GUDID, it's G-U-D I-D, right?

Gary Saner: Yeah, so that stands for the Global Unique Device Identification Database. And that specifically, GUDID, is the way the FDA pronounces that.

Jon Speer: Okay.

Gary Saner: They're a national database of these medical devices. So you can access that database through a web interface, and key individual data records manually, and then go through a quality verification to make sure that transcription errors did not come into play. You wanna make sure everything's correct. That's one way, is to use that online web interface. The second way, the FDA knew that many companies that would just overwhelm them with some manual effort, and have provided an electronic submission. Putting together this data into an XML file is actually one of our core expertise we offer, and submitting that electronic file through the electronic submission gateway. This particular method has been a well-oiled machine now for a couple years, and you can make fast, accurate, electronic submissions. And since there's a database that's underlying that data preparation and maintenance, you can make maintenance and provide for future support, not only to the FDA.

Gary Saner: And then Jon, as we know, there are other regulatory bodies around the world, so there's some global UDI submissions. So having a database of that data record is able to be leveraged, not only for the FDA, but the EU, Health Canada, Australia, Brazil, and it goes down the list.

Jon Speer: Sure.

Gary Saner: One of those things that you want to look at, and especially because of the time, it's very difficult to set up a electronic submission database at this point on your own, internally, and do the validation, and as you know, do all the quality checks and IQ, OQ, PQ sort of thing. I would recommend looking at a well-experienced vendor that has a system up in place. And some of these vendors, including us, we offer this electronic submission gateway setup, it's already in place, and have tiered pricing for those companies that have low-volume submissions. Basically, your two options, then, to summarize that question or that answer, would be the FDA GUD web interface, GUDID web interface with manual entry, or use an electronic submission.

Jon Speer: Right. I was gonna ask about the value, or the importance, or the meaning of the UDI submission even beyond just this impending FDA guideline, and you hit on it for those, of course, but for our audience, there are a lot of quality and regulatory and other medical device professionals who listen to the Global Medical Device Podcast. What are the last, or a few more tips or pointers that you would recommend that people consider as they go through this process?

Gary Saner: Well, it's certainly highly advised by the FDA that you submit high-quality, accurate submissions, and not only to do a good, high-integrity submission, but realize that this data becomes public, and there's a lot of downstream users. There's other downstream users that include hospitals, data aggregators, systems that would go into other types of uses to support the life-sciences area, and specifically, medical device use. You wanna look at something that is able to accommodate very high-quality data collection and submission, and look at the full cost of your solution. Not only the data faction and installation costs, but any manual effort that you might wanna put into play.

Gary Saner: One take-away point that I... Well, couple take-away points. One was, the UDI submission is not a one-time effort. There has to be some ownership for long-term changes. In the event that there's data values that change over the course of time, updates need to be sent to the FDA before that label change is actually applied to the product and shipped out the door. It's one of those checkmarks that need to be done upon releasing new data. That flows into the quality system to make sure that not only all your other quality checks are in place, but that UDI submission has been submitted, and it is accurate. I would imagine that many quality systems, devices, are very typically sold globally. Again, this will affect the global marketplace. Being able to checkmark and say, "Okay this product is now ready for release in EU. Have I made my UDI submissions for EU?" And being able to use your efforts and all your funds that you put together for a US solution, we wanna be able to leverage that for a global.

Gary Saner: And then the last thing I'll mention is timing is really close, Jon, [chuckle] and we wanna try to recommend that this data-collection process is typically underestimated, and it takes a little bit longer than everyone thought it would. And then putting that data... Submitting it together, getting it together, and submitting it to the FDA is another activity, and that's where we can help customers along the way.

Jon Speer: So, start now. And Gary, I appreciate your insights about UDI today. Obviously, we're just skimming the surface, but I wanna let the folks know that we will provide them a link to the Reed Tech Class II Submissions Guide ebook, and we will also provide a link to the Reed Tech data elements chart. Again, if you have a question or comments about UDI, call Gary Saner at Reed Tech, very easy to find. Reed R-E-E-D, tech, T-E-C-H, Gary Saner, S-A-N-E-R. Gary, thanks for being my guest today on the Global Medical Device Podcast, and just one parting word for our audience. Of course, you know about Greenlight.guru. We help companies with design controls, and mismanagement, and quality management systems as they're bringing new devices or dealing with existing devices. If you're interested in learning more about our software platform, be sure to check us out at Greenlight.guru, and request a demo for more information. Until next time, this is Jon Speer the founder and VP of Quality at Greenlight.guru. And this has been the Global Medical Device Podcast.

About The Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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